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ACCOAST: A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01015287
Collaborator
Daiichi Sankyo Co., Ltd. (Industry)
4,033
Enrollment
153
Locations
2
Arms
38
Duration (Months)
26.4
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this trial is to investigate the potential benefits/risks regarding pretreatment with prasugrel in non-ST-elevation myocardial infarction (NSTEMI) participants with elevated troponin scheduled for coronary angiography/percutaneous coronary intervention (PCI).

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

This trial consists of two arms. One arm is a non pre-treatment arm. Participants in this arm will receive placebo immediately after NSTEMI diagnosis and prior to the diagnostic coronary angiography. A 60 mg prasugrel loading dose will be given immediately after coronary angiography when proceeding to PCI. Subsequently, participants will receive daily maintenance doses of prasugrel until day 30. Participants who are greater than or equal to 75 years of age or who have a body weight less than 60 kilograms (kg) will receive 5 mg oral dose daily. All others will receive a 10 mg oral daily maintenance dose for 30 days.

The other arm is a pre-treatment arm where participants will receive a split loading dose regimen with 30 mg of prasugrel administered immediately after NSTEMI diagnosis and prior to diagnostic coronary angiography. The remainder of the loading dose (30 mg) will be administered when the participants are proceeding to PCI. Subsequently, participants will receive daily maintenance doses of prasugrel until day 30. Participants who are greater than or equal to 75 years of age or who have a body weight less than 60 kg will receive 5 mg oral dose daily. All others will receive a 10 mg oral daily maintenance dose for 30 days.

Study Design

Study Type:
Interventional
Actual Enrollment :
4033 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Comparison of Prasugrel at the Time of Percutaneous Coronary Intervention (PCI) Or as Pretreatment At the Time of Diagnosis in Patients With Non-ST-Elevation Myocardial Infarction (NSTEMI): The ACCOAST Study
Study Start Date :
Dec 1, 2009
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Feb 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Non pre-treatment

A placebo oral loading dose is given at the time of diagnosis and a 60 milligrams (mg) oral loading dose of prasugrel is given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.

Drug: Placebo
Administered once orally

Drug: Prasugrel
Administered orally
Other Names:
  • LY640315
  • Efient
  • Effient
  • CS-747

    		•
    Experimental: Split Loading Dose

    A 30 mg oral loading dose of prasugrel is given at diagnosis and a 30 mg oral dose of prasugrel is given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days

    Drug: Prasugrel
    Administered orally
    Other Names:
  • LY640315
  • Efient
  • Effient
  • CS-747

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The Percentage of Participants With Occurrence of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Urgent Revascularization (UR), or Glycoprotein (GP) IIb/IIIa Inhibitor Bailout [First loading dose (LD) through 7 days after first LD]

      The percentage of participants is the total number of participants experiencing a CV death, MI, stroke, UR or GPIIb/IIIa Inhibitor bailout divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.

    Secondary Outcome Measures

    1. Percentage of Participants With All-Cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding [First loading dose (LD) through 7 days after first LD]

      The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.

    2. Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke Through 30 Days From First Loading Dose (LD) [First LD through 30 days after first LD]

      The percentage of participants is the total number of participants experiencing a CV death, MI, or stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.

    3. Percentage of Participants With Incidence of Cardiovascular (CV) Death or Myocardial Infarction (MI) Through 30 Days From First Loading Dose (LD) [First LD through 30 days after first LD]

      The percentage of participants is the total number of participants experiencing a CV death or MI divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.

    4. Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Urgent Revascularization (UR) Through 30 Days From First Loading Dose (LD) [First LD through 30 days after first LD]

      The percentage of participants is the total number of participants experiencing a CV death, MI, or UR divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.

    5. Percentage of Participants With Incidence of Cardiovascular (CV) Death Through 30 Days From First Loading Dose (LD) [First LD through 30 days after first LD]

      The percentage of participants is the total number of participants experiencing a CV death divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.

    6. Percentage of Participants With Incidence of Definite or Probable Stent Thrombosis (ST) According to the Academic Research Consortium (ARC) Criteria Through 30 Days From First Loading Dose (LD) [First LD through 30 days after first LD]

      ARC criteria were used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause. The percentage of participants is the total number of participants experiencing a definite or probable stent thrombosis divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.

    7. Percentage of Participants With All-cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding Through 30 Days From First Loading Dose (LD) [First LD through 30 days after first LD]

      The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.

    8. Change in Standardized Troponin From Baseline to Percutaneous Coronary Intervention (PCI) [Baseline, before PCI (not greater than 48 hours after randomization)]

      Standardized troponin is defined as the ratio of the assayed troponin value divided by the upper limit of normal (ULN). Least Squares (LS) means were obtained from an Analysis of Covariance (ANCOVA) model with treatment as a fixed effect and baseline standardized troponin as a covariate.

    9. Percentage of Participants With Incidence of All Coronary Artery Bypass Graft (CABG) or Non-CABG Thrombolysis In Myocardial Infarction (TIMI) Major Bleeding [First loading dose (LD) through 7 days after first LD]

      The percentage of participants is the total number of participants experiencing a CABG or non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.

    Other Outcome Measures

    1. Summary of All-Cause Death [Randomization through 30 days]

      All deaths, regardless of possible relatedness, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Have acute coronary syndrome consisting of non-ST-segment elevation with elevated troponin

    • Scheduled for coronary angiography/PCI greater than or equal to 2 and less than 24 hours from time of planned randomization, but no more than 48 hours from randomization

    • Must be eligible for treatment with prasugrel, aspirin (ASA), and a glycoprotein IIb/IIIa receptor (GPIIb/IIIa) inhibitor as per respective labels

    • May be on a maintenance dose of clopidogrel 75 mg and must be able to switch to prasugrel

    • Must be enrolled at a cardiac catheterization laboratory hospital or at a hospital/ambulance service affiliated with a cardiac catheterization laboratory hospital

    Exclusion Criteria:

    • Present with ST-segment elevation myocardial infarction (STEMI) at the time of entry or randomization

    • Have cardiogenic shock

    • Have refractory ventricular arrhythmias

    • Have New York Heart Association (NYHA) Class IV congestive heart failure (CHF)

    • Have had cardiac arrest within 1 week of entry or randomization into the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Braunau Am Inn Austria 5280
    2 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Graz Austria 8020
    3 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Linz Austria 4020
    4 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Vienna Austria A1090
    5 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bonheiden Belgium 2820
    6 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Brugge Belgium 8000
    7 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Charleroi Belgium 6000
    8 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Genk Belgium 3600
    9 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Leuven Belgium 3000
    10 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Yvoir Belgium 5530
    11 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Calgary Alberta Canada T2N 2T9
    12 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Vancouver British Columbia Canada Vancouver
    13 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Toronto Ontario Canada M5B 1W8
    14 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Montreal Quebec Canada H4J 1C5
    15 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sainte-Foy Quebec Canada G1V 4G5
    16 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Saskatoon Saskatchewan Canada S7N 0W8
    17 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Brno Czech Republic 625 00
    18 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hradec Kralove Czech Republic 500 05
    19 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Olomouc Czech Republic 775 20
    20 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Plzen Czech Republic 30460
    21 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Prague Czech Republic 169 02
    22 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Usti Nad Labem Czech Republic 40113
    23 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Turku Finland 20521
    24 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bastia France 20600
    25 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bron France 69500
    26 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Caluire Et Cuire France 69300
    27 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cannes Cedex France 06401
    28 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Chateauroux France 36019
    29 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Corbeil Essonnes France 91106
    30 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lagny Sur Marne France 77405
    31 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Le Coudray France 28630
    32 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lille France 59037
    33 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lyon France 69317
    34 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Marseille France 13015
    35 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Metz Tessy France 74370
    36 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Metz France 57085
    37 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Montauban France 82017
    38 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Montreuil France 93105
    39 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nimes France 30029
    40 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Paris France 75743
    41 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Pau Cedex France 64046
    42 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Pierre Benite France 69495
    43 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rennes France 35033
    44 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Toulouse France 31076
    45 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Valence France 26953
    46 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Vannes France 56017
    47 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Vienne France 38209
    48 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Villeurbanne France 69100
    49 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bad Nauheim Germany 61231
    50 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bad Segeberg Germany 23795
    51 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bochum Germany 44791
    52 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bonn Germany 53105
    53 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Coburg Germany 96450
    54 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Dachau Germany 85221
    55 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Eutin Germany 23701
    56 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Frankfurt Germany 60596
    57 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Halle Germany 06120
    58 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hamburg Germany 20099
    59 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hannover Germany 30625
    60 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Heidelberg Germany D-69120
    61 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Jena Germany 07740
    62 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kassel Germany 34125
    63 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Leipzig Germany 04289
    64 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ludwigshafen Germany 67063
    65 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Mainz Germany 55101
    66 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Munich Germany 80336
    67 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rastatt Germany 76437
    68 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rostock Germany 18057
    69 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Villingen-Schwenningen Germany 78050
    70 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Balatonfured Hungary 8230
    71 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Budapest Hungary 1096
    72 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Pecs Hungary 7624
    73 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Zalaegerszeg Hungary 8900
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    145 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Adana Turkey 1330
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    148 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fatih Turkey 34300
    149 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Isparta Turkey 32100
    150 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Istanbul Turkey 34303
    151 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kayseri Turkey 38039
    152 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kocaeli Turkey 41900
    153 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sisli Turkey 34381

    Sponsors and Collaborators

    • Eli Lilly and Company
    • Daiichi Sankyo Co., Ltd.

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT01015287
    Other Study ID Numbers:
    • 12918
    • H7T-MC-TADF
    First Posted:
    Nov 18, 2009
    Last Update Posted:
    Feb 28, 2014
    Last Verified:
    Jan 1, 2014
    Keywords provided by Eli Lilly and Company
    Acute Coronary Syndromes
    Heart Disease
    Percutaneous Coronary Intervention
    P2Y12
    NSTEMI
    Additional relevant MeSH terms:
    Myocardial Infarction
    Acute Coronary Syndrome
    Non-ST Elevated Myocardial Infarction
    Infarction
    Prasugrel Hydrochloride

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Non Pre-treatment Pre-treatment
    Arm/Group Description A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days. A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
    Period Title: Overall Study
    STARTED 1996 2037
    Received at Least 1 Dose of Study Drug 1996 2037
    COMPLETED 1924 1958
    NOT COMPLETED 72 79

    Baseline Characteristics

    Arm/Group Title Non Pre-treatment Pre-treatment Total
    Arm/Group Description A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days. A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days. Total of all reporting groups
    Overall Participants 1996 2037 4033
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    63.59
    (11.239)
    63.80
    (11.270)
    63.69
    (11.254)
    Sex: Female, Male (Count of Participants)
    Female
    558
    28%
    552
    27.1%
    1110
    27.5%
    Male
    1438
    72%
    1485
    72.9%
    2923
    72.5%

    Outcome Measures

    1. Primary Outcome
    Title The Percentage of Participants With Occurrence of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Urgent Revascularization (UR), or Glycoprotein (GP) IIb/IIIa Inhibitor Bailout
    Description The percentage of participants is the total number of participants experiencing a CV death, MI, stroke, UR or GPIIb/IIIa Inhibitor bailout divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
    Time Frame First loading dose (LD) through 7 days after first LD

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug.
    Arm/Group Title Non Pre-treatment Pre-treatment
    Arm/Group Description A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days. A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
    Measure Participants 1996 2037
    Number [percentage of participants]
    9.77
    0.5%
    9.97
    0.5%
    2. Secondary Outcome
    Title Percentage of Participants With All-Cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
    Description The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
    Time Frame First loading dose (LD) through 7 days after first LD

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug.
    Arm/Group Title Non Pre-treatment Pre-treatment
    Arm/Group Description A placebo LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days. A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
    Measure Participants 1996 2037
    Number [percentage of participants]
    7.57
    0.4%
    8.64
    0.4%
    3. Secondary Outcome
    Title Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke Through 30 Days From First Loading Dose (LD)
    Description The percentage of participants is the total number of participants experiencing a CV death, MI, or stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
    Time Frame First LD through 30 days after first LD

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug.
    Arm/Group Title Non Pre-treatment Pre-treatment
    Arm/Group Description A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days. A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
    Measure Participants 1996 2037
    Number [percentage of participants]
    7.21
    0.4%
    7.07
    0.3%
    4. Secondary Outcome
    Title Percentage of Participants With Incidence of Cardiovascular (CV) Death or Myocardial Infarction (MI) Through 30 Days From First Loading Dose (LD)
    Description The percentage of participants is the total number of participants experiencing a CV death or MI divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
    Time Frame First LD through 30 days after first LD

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug.
    Arm/Group Title Non Pre-treatment Pre-treatment
    Arm/Group Description A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days. A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
    Measure Participants 1996 2037
    Number [percentage of participants]
    6.51
    0.3%
    6.63
    0.3%
    5. Secondary Outcome
    Title Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Urgent Revascularization (UR) Through 30 Days From First Loading Dose (LD)
    Description The percentage of participants is the total number of participants experiencing a CV death, MI, or UR divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
    Time Frame First LD through 30 days after first LD

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug.
    Arm/Group Title Non Pre-treatment Pre-treatment
    Arm/Group Description A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days. A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
    Measure Participants 1996 2037
    Number [percentage of participants]
    7.31
    0.4%
    7.71
    0.4%
    6. Secondary Outcome
    Title Percentage of Participants With Incidence of Cardiovascular (CV) Death Through 30 Days From First Loading Dose (LD)
    Description The percentage of participants is the total number of participants experiencing a CV death divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
    Time Frame First LD through 30 days after first LD

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug.
    Arm/Group Title Non Pre-treatment Pre-treatment
    Arm/Group Description A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days. A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
    Measure Participants 1996 2037
    Number [percentage of participants]
    1.10
    0.1%
    0.69
    0%
    7. Secondary Outcome
    Title Percentage of Participants With Incidence of Definite or Probable Stent Thrombosis (ST) According to the Academic Research Consortium (ARC) Criteria Through 30 Days From First Loading Dose (LD)
    Description ARC criteria were used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause. The percentage of participants is the total number of participants experiencing a definite or probable stent thrombosis divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
    Time Frame First LD through 30 days after first LD

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug.
    Arm/Group Title Non Pre-treatment Pre-treatment
    Arm/Group Description A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days. A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
    Measure Participants 1996 2037
    Number [percentage of participants]
    0.25
    0%
    0.10
    0%
    8. Secondary Outcome
    Title Percentage of Participants With All-cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding Through 30 Days From First Loading Dose (LD)
    Description The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
    Time Frame First LD through 30 days after first LD

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug.
    Arm/Group Title Non Pre-treatment Pre-treatment
    Arm/Group Description A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days. A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
    Measure Participants 1996 2037
    Number [percentage of participants]
    8.52
    0.4%
    9.47
    0.5%
    9. Secondary Outcome
    Title Change in Standardized Troponin From Baseline to Percutaneous Coronary Intervention (PCI)
    Description Standardized troponin is defined as the ratio of the assayed troponin value divided by the upper limit of normal (ULN). Least Squares (LS) means were obtained from an Analysis of Covariance (ANCOVA) model with treatment as a fixed effect and baseline standardized troponin as a covariate.
    Time Frame Baseline, before PCI (not greater than 48 hours after randomization)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug, had standardized troponin measured at baseline and before PCI (not greater than 48 hours after randomization).
    Arm/Group Title Non Pre-treatment Pre-treatment
    Arm/Group Description A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days. A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
    Measure Participants 454 511
    Least Squares Mean (Standard Error) [ratio of assayed troponin/ULN]
    -11.24
    (8.93)
    2.82
    (8.42)
    10. Secondary Outcome
    Title Percentage of Participants With Incidence of All Coronary Artery Bypass Graft (CABG) or Non-CABG Thrombolysis In Myocardial Infarction (TIMI) Major Bleeding
    Description The percentage of participants is the total number of participants experiencing a CABG or non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
    Time Frame First loading dose (LD) through 7 days after first LD

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug.
    Arm/Group Title Non Pre-treatment Pre-treatment
    Arm/Group Description A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days. A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
    Measure Participants 1996 2037
    Number [percentage of participants]
    1.35
    0.1%
    2.55
    0.1%
    11. Other Pre-specified Outcome
    Title Summary of All-Cause Death
    Description All deaths, regardless of possible relatedness, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table.
    Time Frame Randomization through 30 days

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug.
    Arm/Group Title Non Pre-treatment Pre-treatment
    Arm/Group Description A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days. A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
    Measure Participants 1996 2037
    Congestive Heart Failure
    1
    0.1%
    0
    0%
    Cardiogenic Shock
    5
    0.3%
    5
    0.2%
    During or Immediately Following a CABG Procedure
    5
    0.3%
    1
    0%
    During or Immediately Following a PCI Procedure
    2
    0.1%
    1
    0%
    Myocardial Infarction
    2
    0.1%
    1
    0%
    Dysrhythmia
    0
    0%
    1
    0%
    Sudden Cardiac Death
    4
    0.2%
    1
    0%
    Intracranial Hemorrhage
    1
    0.1%
    1
    0%
    Stroke, non-hemorrhagic
    0
    0%
    1
    0%
    Other Cardiovascular
    2
    0.1%
    2
    0.1%
    Non-Cardiac Hemorrhage, Not Intracranial
    0
    0%
    1
    0%
    Infection
    1
    0.1%
    0
    0%
    Cancer
    0
    0%
    1
    0%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Non Pre-treatment Pre-treatment
    Arm/Group Description A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days. A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
    All Cause Mortality
    Non Pre-treatment Pre-treatment
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Non Pre-treatment Pre-treatment
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 167/1996 (8.4%) 206/2037 (10.1%)
    Blood and lymphatic system disorders
    Anaemia 1/1996 (0.1%) 1 1/2037 (0%) 1
    Anaemia vitamin B12 deficiency 0/1996 (0%) 0 1/2037 (0%) 1
    Hyperchromic anaemia 1/1996 (0.1%) 1 0/2037 (0%) 0
    Splenic infarction 0/1996 (0%) 0 1/2037 (0%) 1
    Thrombocytosis 0/1996 (0%) 0 1/2037 (0%) 1
    Cardiac disorders
    Acute coronary syndrome 1/1996 (0.1%) 1 1/2037 (0%) 1
    Acute myocardial infarction 3/1996 (0.2%) 3 6/2037 (0.3%) 6
    Angina pectoris 1/1996 (0.1%) 1 5/2037 (0.2%) 6
    Angina unstable 2/1996 (0.1%) 2 6/2037 (0.3%) 6
    Aortic valve incompetence 1/1996 (0.1%) 1 0/2037 (0%) 0
    Aortic valve stenosis 0/1996 (0%) 0 1/2037 (0%) 1
    Arrhythmia 0/1996 (0%) 0 1/2037 (0%) 1
    Arteriospasm coronary 2/1996 (0.1%) 2 0/2037 (0%) 0
    Atrial fibrillation 4/1996 (0.2%) 5 3/2037 (0.1%) 3
    Atrioventricular block 1/1996 (0.1%) 1 0/2037 (0%) 0
    Atrioventricular block complete 1/1996 (0.1%) 1 1/2037 (0%) 1
    Atrioventricular block first degree 0/1996 (0%) 0 1/2037 (0%) 1
    Atrioventricular block second degree 1/1996 (0.1%) 1 0/2037 (0%) 0
    Bifascicular block 0/1996 (0%) 0 1/2037 (0%) 1
    Bradycardia 0/1996 (0%) 0 2/2037 (0.1%) 2
    Cardiac arrest 3/1996 (0.2%) 3 5/2037 (0.2%) 5
    Cardiac failure 4/1996 (0.2%) 4 3/2037 (0.1%) 4
    Cardiac failure acute 0/1996 (0%) 0 2/2037 (0.1%) 2
    Cardiac failure congestive 2/1996 (0.1%) 2 0/2037 (0%) 0
    Cardiac tamponade 2/1996 (0.1%) 2 3/2037 (0.1%) 3
    Cardio-respiratory arrest 1/1996 (0.1%) 1 0/2037 (0%) 0
    Cardiogenic shock 5/1996 (0.3%) 5 7/2037 (0.3%) 7
    Coronary artery disease 0/1996 (0%) 0 1/2037 (0%) 1
    Coronary artery dissection 2/1996 (0.1%) 2 3/2037 (0.1%) 3
    Coronary artery embolism 0/1996 (0%) 0 1/2037 (0%) 1
    Coronary artery occlusion 0/1996 (0%) 0 2/2037 (0.1%) 2
    Coronary artery thrombosis 4/1996 (0.2%) 4 5/2037 (0.2%) 5
    Coronary no-reflow phenomenon 1/1996 (0.1%) 1 0/2037 (0%) 0
    Coronary ostial stenosis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Haemorrhage coronary artery 0/1996 (0%) 0 1/2037 (0%) 1
    Intracardiac thrombus 1/1996 (0.1%) 1 0/2037 (0%) 0
    Left ventricular failure 2/1996 (0.1%) 2 0/2037 (0%) 0
    Myocardial infarction 10/1996 (0.5%) 10 15/2037 (0.7%) 15
    Myocardial ischaemia 1/1996 (0.1%) 1 0/2037 (0%) 0
    Myocardial rupture 1/1996 (0.1%) 1 0/2037 (0%) 0
    Pericardial effusion 4/1996 (0.2%) 4 0/2037 (0%) 0
    Pericardial haemorrhage 0/1996 (0%) 0 3/2037 (0.1%) 3
    Pericarditis 1/1996 (0.1%) 1 1/2037 (0%) 1
    Pericarditis constrictive 1/1996 (0.1%) 1 0/2037 (0%) 0
    Pleuropericarditis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Postinfarction angina 1/1996 (0.1%) 1 0/2037 (0%) 0
    Sinus arrest 1/1996 (0.1%) 1 0/2037 (0%) 0
    Sinus bradycardia 0/1996 (0%) 0 1/2037 (0%) 1
    Supraventricular tachycardia 0/1996 (0%) 0 1/2037 (0%) 1
    Ventricular fibrillation 5/1996 (0.3%) 5 7/2037 (0.3%) 7
    Ventricular flutter 1/1996 (0.1%) 1 0/2037 (0%) 0
    Ventricular tachycardia 4/1996 (0.2%) 4 4/2037 (0.2%) 4
    Ear and labyrinth disorders
    Vertigo 0/1996 (0%) 0 1/2037 (0%) 1
    Endocrine disorders
    Hypothyroidism 1/1996 (0.1%) 1 0/2037 (0%) 0
    Gastrointestinal disorders
    Abdominal pain 1/1996 (0.1%) 1 0/2037 (0%) 0
    Colitis ischaemic 0/1996 (0%) 0 1/2037 (0%) 1
    Faeces discoloured 1/1996 (0.1%) 1 0/2037 (0%) 0
    Flatulence 0/1996 (0%) 0 1/2037 (0%) 1
    Gastric haemorrhage 0/1996 (0%) 0 2/2037 (0.1%) 2
    Gastritis 0/1996 (0%) 0 2/2037 (0.1%) 2
    Gastrointestinal haemorrhage 3/1996 (0.2%) 3 5/2037 (0.2%) 5
    Gingival bleeding 1/1996 (0.1%) 1 0/2037 (0%) 0
    Haemorrhoidal haemorrhage 1/1996 (0.1%) 1 0/2037 (0%) 0
    Intestinal perforation 0/1996 (0%) 0 1/2037 (0%) 1
    Mesenteric artery thrombosis 0/1996 (0%) 0 1/2037 (0%) 1
    Oesophagitis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Peritoneal haematoma 0/1996 (0%) 0 1/2037 (0%) 1
    Rectal haemorrhage 0/1996 (0%) 0 2/2037 (0.1%) 2
    Retroperitoneal haematoma 0/1996 (0%) 0 2/2037 (0.1%) 2
    Retroperitoneal haemorrhage 1/1996 (0.1%) 1 3/2037 (0.1%) 3
    General disorders
    Asthenia 1/1996 (0.1%) 1 0/2037 (0%) 0
    Chest pain 8/1996 (0.4%) 8 9/2037 (0.4%) 9
    Device dislocation 0/1996 (0%) 0 1/2037 (0%) 1
    Non-cardiac chest pain 3/1996 (0.2%) 3 1/2037 (0%) 1
    Puncture site haemorrhage 1/1996 (0.1%) 1 1/2037 (0%) 1
    Pyrexia 1/1996 (0.1%) 1 0/2037 (0%) 0
    Spinal pain 0/1996 (0%) 0 1/2037 (0%) 1
    Sudden cardiac death 1/1996 (0.1%) 1 0/2037 (0%) 0
    Sudden death 1/1996 (0.1%) 1 0/2037 (0%) 0
    Thrombosis in device 4/1996 (0.2%) 5 1/2037 (0%) 1
    Vessel puncture site haematoma 2/1996 (0.1%) 2 1/2037 (0%) 1
    Vessel puncture site haemorrhage 0/1996 (0%) 0 2/2037 (0.1%) 2
    Hepatobiliary disorders
    Biliary tract disorder 0/1996 (0%) 0 1/2037 (0%) 1
    Cholecystitis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Cholecystitis acute 1/1996 (0.1%) 1 0/2037 (0%) 0
    Cholelithiasis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Hepatic necrosis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Immune system disorders
    Hypersensitivity 1/1996 (0.1%) 1 0/2037 (0%) 0
    Infections and infestations
    Bronchitis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Cystitis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Gastroenteritis 0/1996 (0%) 0 2/2037 (0.1%) 2
    Groin abscess 1/1996 (0.1%) 1 0/2037 (0%) 0
    Labyrinthitis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Nasopharyngitis 0/1996 (0%) 0 1/2037 (0%) 1
    Pneumonia 1/1996 (0.1%) 1 4/2037 (0.2%) 4
    Puncture site infection 1/1996 (0.1%) 1 0/2037 (0%) 0
    Sepsis 1/1996 (0.1%) 1 2/2037 (0.1%) 2
    Sinusitis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Urinary tract infection 0/1996 (0%) 0 2/2037 (0.1%) 2
    Injury, poisoning and procedural complications
    Accidental overdose 0/1996 (0%) 0 1/2037 (0%) 1
    Cardiac procedure complication 1/1996 (0.1%) 1 0/2037 (0%) 0
    Fall 1/1996 (0.1%) 1 0/2037 (0%) 0
    Graft thrombosis 0/1996 (0%) 0 1/2037 (0%) 1
    Overdose 1/1996 (0.1%) 1 0/2037 (0%) 0
    Post procedural haematoma 1/1996 (0.1%) 1 4/2037 (0.2%) 4
    Post procedural haemorrhage 0/1996 (0%) 0 6/2037 (0.3%) 6
    Post procedural myocardial infarction 1/1996 (0.1%) 1 0/2037 (0%) 0
    Postoperative thrombosis 0/1996 (0%) 0 2/2037 (0.1%) 2
    Procedural haemorrhage 4/1996 (0.2%) 4 6/2037 (0.3%) 6
    Subcutaneous haematoma 0/1996 (0%) 0 1/2037 (0%) 1
    Toxicity to various agents 0/1996 (0%) 0 1/2037 (0%) 1
    Vascular pseudoaneurysm 2/1996 (0.1%) 2 6/2037 (0.3%) 6
    Vena cava injury 0/1996 (0%) 0 1/2037 (0%) 1
    Investigations
    Blood creatine phosphokinase increased 1/1996 (0.1%) 1 0/2037 (0%) 0
    Cardiac output decreased 1/1996 (0.1%) 1 0/2037 (0%) 0
    Ejection fraction decreased 1/1996 (0.1%) 1 0/2037 (0%) 0
    Haemoglobin decreased 2/1996 (0.1%) 2 2/2037 (0.1%) 2
    Inflammatory marker increased 0/1996 (0%) 0 1/2037 (0%) 1
    Troponin increased 0/1996 (0%) 0 2/2037 (0.1%) 2
    Troponin t increased 1/1996 (0.1%) 1 1/2037 (0%) 1
    Metabolism and nutrition disorders
    Diabetes mellitus 1/1996 (0.1%) 1 0/2037 (0%) 0
    Hypokalaemia 1/1996 (0.1%) 1 0/2037 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/1996 (0.1%) 1 0/2037 (0%) 0
    Musculoskeletal pain 0/1996 (0%) 0 1/2037 (0%) 1
    Rhabdomyolysis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Spondylitis 0/1996 (0%) 0 1/2037 (0%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bronchial carcinoma 0/1996 (0%) 0 1/2037 (0%) 1
    Central nervous system lymphoma 1/1996 (0.1%) 1 0/2037 (0%) 0
    Colon cancer 1/1996 (0.1%) 1 0/2037 (0%) 0
    Lung neoplasm 0/1996 (0%) 0 1/2037 (0%) 1
    Rectal cancer 0/1996 (0%) 0 1/2037 (0%) 1
    Renal neoplasm 1/1996 (0.1%) 1 0/2037 (0%) 0
    Nervous system disorders
    Carotid artery stenosis 0/1996 (0%) 0 1/2037 (0%) 1
    Cerebrovascular accident 2/1996 (0.1%) 2 2/2037 (0.1%) 2
    Convulsion 1/1996 (0.1%) 1 0/2037 (0%) 0
    Dizziness 2/1996 (0.1%) 2 0/2037 (0%) 0
    Haemorrhage intracranial 0/1996 (0%) 0 1/2037 (0%) 1
    Haemorrhagic stroke 1/1996 (0.1%) 1 0/2037 (0%) 0
    Hypotonia 0/1996 (0%) 0 1/2037 (0%) 1
    Intracranial aneurysm 0/1996 (0%) 0 1/2037 (0%) 1
    Ischaemic stroke 2/1996 (0.1%) 2 2/2037 (0.1%) 2
    Monoplegia 0/1996 (0%) 0 1/2037 (0%) 1
    Syncope 2/1996 (0.1%) 2 3/2037 (0.1%) 3
    Transient ischaemic attack 1/1996 (0.1%) 1 2/2037 (0.1%) 2
    Psychiatric disorders
    Disorientation 1/1996 (0.1%) 1 0/2037 (0%) 0
    Renal and urinary disorders
    Haematuria 1/1996 (0.1%) 1 2/2037 (0.1%) 2
    Nephropathy toxic 0/1996 (0%) 0 1/2037 (0%) 1
    Renal failure 0/1996 (0%) 0 3/2037 (0.1%) 3
    Renal failure acute 2/1996 (0.1%) 2 1/2037 (0%) 1
    Renal failure chronic 1/1996 (0.1%) 1 1/2037 (0%) 1
    Renal impairment 0/1996 (0%) 0 1/2037 (0%) 1
    Renal tubular necrosis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema 0/1996 (0%) 0 1/2037 (0%) 2
    Bronchospasm 0/1996 (0%) 0 1/2037 (0%) 1
    Chronic obstructive pulmonary disease 1/1996 (0.1%) 1 0/2037 (0%) 0
    Dyspnoea 2/1996 (0.1%) 2 0/2037 (0%) 0
    Epistaxis 2/1996 (0.1%) 2 0/2037 (0%) 0
    Hyperventilation 0/1996 (0%) 0 1/2037 (0%) 1
    Laryngeal oedema 1/1996 (0.1%) 1 0/2037 (0%) 0
    Pleural effusion 3/1996 (0.2%) 4 0/2037 (0%) 0
    Pulmonary alveolar haemorrhage 0/1996 (0%) 0 1/2037 (0%) 1
    Pulmonary embolism 5/1996 (0.3%) 5 4/2037 (0.2%) 4
    Pulmonary haemorrhage 0/1996 (0%) 0 1/2037 (0%) 1
    Pulmonary oedema 4/1996 (0.2%) 4 3/2037 (0.1%) 4
    Respiratory failure 2/1996 (0.1%) 2 1/2037 (0%) 1
    Respiratory tract haemorrhage 0/1996 (0%) 0 1/2037 (0%) 1
    Skin and subcutaneous tissue disorders
    Acute generalised exanthematous pustulosis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Photosensitivity reaction 1/1996 (0.1%) 1 0/2037 (0%) 0
    Rash 0/1996 (0%) 0 1/2037 (0%) 1
    Surgical and medical procedures
    Coronary artery bypass 5/1996 (0.3%) 5 6/2037 (0.3%) 6
    Coronary revascularisation 1/1996 (0.1%) 1 0/2037 (0%) 0
    Percutaneous coronary intervention 10/1996 (0.5%) 10 16/2037 (0.8%) 17
    Thrombolysis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Vascular disorders
    Aneurysm 0/1996 (0%) 0 1/2037 (0%) 1
    Arterial haemorrhage 0/1996 (0%) 0 1/2037 (0%) 1
    Arterial rupture 0/1996 (0%) 0 1/2037 (0%) 1
    Embolism 0/1996 (0%) 0 1/2037 (0%) 1
    Femoral artery occlusion 0/1996 (0%) 0 1/2037 (0%) 1
    Haematoma 3/1996 (0.2%) 3 6/2037 (0.3%) 6
    Haemodynamic instability 1/1996 (0.1%) 1 0/2037 (0%) 0
    Haemorrhage 2/1996 (0.1%) 2 3/2037 (0.1%) 3
    Hypertension 2/1996 (0.1%) 2 0/2037 (0%) 0
    Hypertensive crisis 0/1996 (0%) 0 1/2037 (0%) 1
    Hypotension 0/1996 (0%) 0 2/2037 (0.1%) 2
    Ischaemia 1/1996 (0.1%) 1 1/2037 (0%) 1
    Peripheral arterial occlusive disease 1/1996 (0.1%) 1 0/2037 (0%) 0
    Peripheral artery thrombosis 2/1996 (0.1%) 2 0/2037 (0%) 0
    Peripheral ischaemia 0/1996 (0%) 0 1/2037 (0%) 1
    Shock 1/1996 (0.1%) 1 0/2037 (0%) 0
    Thrombosis 0/1996 (0%) 0 1/2037 (0%) 1
    Venous thrombosis limb 0/1996 (0%) 0 2/2037 (0.1%) 2
    Other (Not Including Serious) Adverse Events
    Non Pre-treatment Pre-treatment
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 860/1996 (43.1%) 876/2037 (43%)
    Blood and lymphatic system disorders
    Anaemia 10/1996 (0.5%) 10 17/2037 (0.8%) 17
    Anaemia macrocytic 1/1996 (0.1%) 1 0/2037 (0%) 0
    Coagulopathy 0/1996 (0%) 0 1/2037 (0%) 1
    Haemorrhagic anaemia 1/1996 (0.1%) 1 0/2037 (0%) 0
    Iron deficiency anaemia 1/1996 (0.1%) 1 2/2037 (0.1%) 2
    Leukocytosis 3/1996 (0.2%) 3 4/2037 (0.2%) 4
    Macrocytosis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Normochromic normocytic anaemia 1/1996 (0.1%) 1 0/2037 (0%) 0
    Pancytopenia 0/1996 (0%) 0 1/2037 (0%) 1
    Polycythaemia 2/1996 (0.1%) 2 1/2037 (0%) 1
    Spontaneous haematoma 1/1996 (0.1%) 1 2/2037 (0.1%) 2
    Thrombocytopenia 4/1996 (0.2%) 4 5/2037 (0.2%) 5
    Cardiac disorders
    Accelerated idioventricular rhythm 3/1996 (0.2%) 3 0/2037 (0%) 0
    Acute coronary syndrome 1/1996 (0.1%) 1 0/2037 (0%) 0
    Acute myocardial infarction 1/1996 (0.1%) 1 3/2037 (0.1%) 3
    Angina pectoris 18/1996 (0.9%) 19 14/2037 (0.7%) 15
    Angina unstable 6/1996 (0.3%) 6 4/2037 (0.2%) 4
    Aortic valve incompetence 5/1996 (0.3%) 5 5/2037 (0.2%) 5
    Aortic valve sclerosis 0/1996 (0%) 0 2/2037 (0.1%) 2
    Aortic valve stenosis 3/1996 (0.2%) 3 3/2037 (0.1%) 3
    Arrhythmia 2/1996 (0.1%) 2 3/2037 (0.1%) 3
    Arrhythmia supraventricular 3/1996 (0.2%) 3 0/2037 (0%) 0
    Arteriosclerosis coronary artery 1/1996 (0.1%) 1 1/2037 (0%) 1
    Atrial fibrillation 28/1996 (1.4%) 28 36/2037 (1.8%) 38
    Atrial flutter 5/1996 (0.3%) 5 3/2037 (0.1%) 3
    Atrial tachycardia 1/1996 (0.1%) 1 0/2037 (0%) 0
    Atrioventricular block 2/1996 (0.1%) 2 0/2037 (0%) 0
    Atrioventricular block complete 1/1996 (0.1%) 1 1/2037 (0%) 1
    Atrioventricular block first degree 2/1996 (0.1%) 2 2/2037 (0.1%) 2
    Atrioventricular block second degree 0/1996 (0%) 0 6/2037 (0.3%) 6
    Bradycardia 21/1996 (1.1%) 21 25/2037 (1.2%) 25
    Bundle branch block right 1/1996 (0.1%) 1 0/2037 (0%) 0
    Cardiac aneurysm 1/1996 (0.1%) 1 0/2037 (0%) 0
    Cardiac arrest 0/1996 (0%) 0 1/2037 (0%) 1
    Cardiac disorder 0/1996 (0%) 0 1/2037 (0%) 1
    Cardiac failure 21/1996 (1.1%) 21 15/2037 (0.7%) 15
    Cardiac failure acute 0/1996 (0%) 0 1/2037 (0%) 1
    Cardiac failure congestive 1/1996 (0.1%) 1 1/2037 (0%) 1
    Cardiac valve disease 0/1996 (0%) 0 1/2037 (0%) 1
    Cardiomegaly 1/1996 (0.1%) 1 1/2037 (0%) 1
    Cardiovascular disorder 0/1996 (0%) 0 1/2037 (0%) 1
    Cardiovascular insufficiency 1/1996 (0.1%) 1 0/2037 (0%) 0
    Congestive cardiomyopathy 0/1996 (0%) 0 1/2037 (0%) 1
    Coronary artery disease 1/1996 (0.1%) 1 4/2037 (0.2%) 4
    Coronary artery dissection 3/1996 (0.2%) 3 1/2037 (0%) 1
    Coronary artery embolism 0/1996 (0%) 0 1/2037 (0%) 1
    Coronary artery occlusion 2/1996 (0.1%) 2 6/2037 (0.3%) 6
    Coronary artery perforation 0/1996 (0%) 0 2/2037 (0.1%) 2
    Coronary artery stenosis 2/1996 (0.1%) 2 2/2037 (0.1%) 2
    Coronary artery thrombosis 3/1996 (0.2%) 3 7/2037 (0.3%) 7
    Coronary no-reflow phenomenon 1/1996 (0.1%) 1 0/2037 (0%) 0
    Diastolic dysfunction 0/1996 (0%) 0 2/2037 (0.1%) 2
    Dressler's syndrome 1/1996 (0.1%) 1 0/2037 (0%) 0
    Hypertensive cardiomyopathy 1/1996 (0.1%) 1 0/2037 (0%) 0
    Hypertrophic cardiomyopathy 0/1996 (0%) 0 1/2037 (0%) 1
    Intracardiac thrombus 0/1996 (0%) 0 1/2037 (0%) 1
    Ischaemic cardiomyopathy 0/1996 (0%) 0 1/2037 (0%) 1
    Left ventricular dysfunction 2/1996 (0.1%) 2 6/2037 (0.3%) 6
    Left ventricular failure 1/1996 (0.1%) 1 0/2037 (0%) 0
    Left ventricular hypertrophy 0/1996 (0%) 0 1/2037 (0%) 1
    Mitral valve incompetence 17/1996 (0.9%) 17 19/2037 (0.9%) 19
    Myocardial haemorrhage 1/1996 (0.1%) 1 0/2037 (0%) 0
    Myocardial infarction 49/1996 (2.5%) 50 41/2037 (2%) 41
    Myocardial ischaemia 0/1996 (0%) 0 2/2037 (0.1%) 2
    Myocarditis 3/1996 (0.2%) 3 2/2037 (0.1%) 2
    Palpitations 7/1996 (0.4%) 7 2/2037 (0.1%) 2
    Pericardial effusion 2/1996 (0.1%) 2 1/2037 (0%) 1
    Pericarditis 3/1996 (0.2%) 3 0/2037 (0%) 0
    Pericarditis constrictive 0/1996 (0%) 0 1/2037 (0%) 1
    Pulmonary valve incompetence 1/1996 (0.1%) 1 0/2037 (0%) 0
    Sick sinus syndrome 2/1996 (0.1%) 2 0/2037 (0%) 0
    Sinoatrial block 1/1996 (0.1%) 1 0/2037 (0%) 0
    Sinus arrest 1/1996 (0.1%) 1 0/2037 (0%) 0
    Sinus bradycardia 2/1996 (0.1%) 2 3/2037 (0.1%) 3
    Sinus tachycardia 3/1996 (0.2%) 3 0/2037 (0%) 0
    Stress cardiomyopathy 2/1996 (0.1%) 2 0/2037 (0%) 0
    Supraventricular extrasystoles 0/1996 (0%) 0 1/2037 (0%) 1
    Supraventricular tachycardia 3/1996 (0.2%) 3 3/2037 (0.1%) 3
    Tachyarrhythmia 2/1996 (0.1%) 2 1/2037 (0%) 1
    Tachycardia 3/1996 (0.2%) 3 7/2037 (0.3%) 7
    Tachycardia paroxysmal 0/1996 (0%) 0 1/2037 (0%) 1
    Tricuspid valve incompetence 10/1996 (0.5%) 10 6/2037 (0.3%) 6
    Ventricular arrhythmia 1/1996 (0.1%) 1 0/2037 (0%) 0
    Ventricular extrasystoles 4/1996 (0.2%) 4 5/2037 (0.2%) 5
    Ventricular failure 1/1996 (0.1%) 1 0/2037 (0%) 0
    Ventricular fibrillation 0/1996 (0%) 0 1/2037 (0%) 1
    Ventricular hypokinesia 2/1996 (0.1%) 2 2/2037 (0.1%) 2
    Ventricular tachyarrhythmia 0/1996 (0%) 0 1/2037 (0%) 1
    Ventricular tachycardia 10/1996 (0.5%) 12 16/2037 (0.8%) 16
    Congenital, familial and genetic disorders
    Gene mutation 0/1996 (0%) 0 1/2037 (0%) 1
    Right aortic arch 0/1996 (0%) 0 1/2037 (0%) 1
    Type v hyperlipidaemia 0/1996 (0%) 0 3/2037 (0.1%) 3
    Ear and labyrinth disorders
    Ear discomfort 0/1996 (0%) 0 1/2037 (0%) 1
    Ear haemorrhage 1/1996 (0.1%) 1 0/2037 (0%) 0
    Hypoacusis 0/1996 (0%) 0 1/2037 (0%) 1
    Tympanic membrane perforation 0/1996 (0%) 0 1/2037 (0%) 1
    Vertigo 5/1996 (0.3%) 5 11/2037 (0.5%) 11
    Vertigo positional 1/1996 (0.1%) 1 0/2037 (0%) 0
    Endocrine disorders
    Autoimmune thyroiditis 0/1996 (0%) 0 1/2037 (0%) 1
    Goitre 2/1996 (0.1%) 2 0/2037 (0%) 0
    Hyperthyroidism 4/1996 (0.2%) 4 4/2037 (0.2%) 4
    Hypothyroidism 4/1996 (0.2%) 4 2/2037 (0.1%) 2
    Eye disorders
    Conjunctival haemorrhage 0/1996 (0%) 0 1/2037 (0%) 1
    Diplopia 2/1996 (0.1%) 2 0/2037 (0%) 0
    Eye haemorrhage 0/1996 (0%) 0 2/2037 (0.1%) 2
    Eye oedema 1/1996 (0.1%) 1 0/2037 (0%) 0
    Panophthalmitis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Refraction disorder 0/1996 (0%) 0 1/2037 (0%) 1
    Ulcerative keratitis 0/1996 (0%) 0 1/2037 (0%) 1
    Visual impairment 0/1996 (0%) 0 1/2037 (0%) 1
    Gastrointestinal disorders
    Abdominal discomfort 3/1996 (0.2%) 3 0/2037 (0%) 0
    Abdominal distension 1/1996 (0.1%) 1 1/2037 (0%) 1
    Abdominal pain 10/1996 (0.5%) 11 8/2037 (0.4%) 8
    Abdominal pain upper 4/1996 (0.2%) 4 12/2037 (0.6%) 12
    Anal fissure 1/1996 (0.1%) 1 1/2037 (0%) 1
    Ascites 0/1996 (0%) 0 1/2037 (0%) 1
    Constipation 11/1996 (0.6%) 11 8/2037 (0.4%) 8
    Diarrhoea 19/1996 (1%) 19 19/2037 (0.9%) 19
    Diverticulum 0/1996 (0%) 0 1/2037 (0%) 1
    Dry mouth 1/1996 (0.1%) 1 0/2037 (0%) 0
    Duodenal ulcer 1/1996 (0.1%) 1 0/2037 (0%) 0
    Duodenitis 1/1996 (0.1%) 1 1/2037 (0%) 1
    Dyspepsia 5/1996 (0.3%) 5 2/2037 (0.1%) 2
    Enteritis 0/1996 (0%) 0 1/2037 (0%) 1
    Epigastric discomfort 1/1996 (0.1%) 1 1/2037 (0%) 1
    Faeces discoloured 1/1996 (0.1%) 1 0/2037 (0%) 0
    Flatulence 0/1996 (0%) 0 1/2037 (0%) 1
    Gastric disorder 1/1996 (0.1%) 1 0/2037 (0%) 0
    Gastritis 3/1996 (0.2%) 3 6/2037 (0.3%) 6
    Gastroduodenitis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Gastrointestinal haemorrhage 0/1996 (0%) 0 2/2037 (0.1%) 2
    Gastrointestinal inflammation 1/1996 (0.1%) 1 0/2037 (0%) 0
    Gastrooesophageal reflux disease 1/1996 (0.1%) 1 4/2037 (0.2%) 4
    Gingival bleeding 9/1996 (0.5%) 9 2/2037 (0.1%) 2
    Haematochezia 5/1996 (0.3%) 5 2/2037 (0.1%) 2
    Haemorrhoidal haemorrhage 1/1996 (0.1%) 1 2/2037 (0.1%) 2
    Haemorrhoids 2/1996 (0.1%) 2 0/2037 (0%) 0
    Hiatus hernia 1/1996 (0.1%) 1 1/2037 (0%) 1
    Intestinal haemorrhage 0/1996 (0%) 0 1/2037 (0%) 1
    Intestinal obstruction 1/1996 (0.1%) 1 0/2037 (0%) 0
    Lip oedema 0/1996 (0%) 0 1/2037 (0%) 1
    Mechanical ileus 1/1996 (0.1%) 1 0/2037 (0%) 0
    Melaena 1/1996 (0.1%) 1 3/2037 (0.1%) 3
    Mesenteric haematoma 0/1996 (0%) 0 1/2037 (0%) 1
    Mouth haemorrhage 1/1996 (0.1%) 1 0/2037 (0%) 0
    Nausea 22/1996 (1.1%) 22 25/2037 (1.2%) 25
    Oesophagitis 0/1996 (0%) 0 1/2037 (0%) 1
    Oral disorder 1/1996 (0.1%) 1 0/2037 (0%) 0
    Oral pain 1/1996 (0.1%) 1 0/2037 (0%) 0
    Pancreatic cyst 1/1996 (0.1%) 1 0/2037 (0%) 0
    Peptic ulcer 1/1996 (0.1%) 1 1/2037 (0%) 1
    Rectal haemorrhage 1/1996 (0.1%) 1 0/2037 (0%) 0
    Rectal polyp 1/1996 (0.1%) 1 0/2037 (0%) 0
    Retroperitoneal haematoma 0/1996 (0%) 0 1/2037 (0%) 1
    Toothache 3/1996 (0.2%) 3 2/2037 (0.1%) 2
    Vomiting 10/1996 (0.5%) 10 9/2037 (0.4%) 9
    General disorders
    Asthenia 17/1996 (0.9%) 17 15/2037 (0.7%) 15
    Catheter site discharge 0/1996 (0%) 0 1/2037 (0%) 1
    Catheter site erythema 2/1996 (0.1%) 2 0/2037 (0%) 0
    Catheter site haematoma 6/1996 (0.3%) 6 5/2037 (0.2%) 5
    Catheter site haemorrhage 5/1996 (0.3%) 5 7/2037 (0.3%) 8
    Catheter site inflammation 1/1996 (0.1%) 1 0/2037 (0%) 0
    Catheter site pain 2/1996 (0.1%) 2 0/2037 (0%) 0
    Catheter site phlebitis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Chest discomfort 6/1996 (0.3%) 6 6/2037 (0.3%) 6
    Chest pain 55/1996 (2.8%) 56 47/2037 (2.3%) 50
    Chills 1/1996 (0.1%) 1 0/2037 (0%) 0
    Cyst 1/1996 (0.1%) 1 0/2037 (0%) 0
    Device dislocation 1/1996 (0.1%) 1 0/2037 (0%) 0
    Discomfort 1/1996 (0.1%) 1 1/2037 (0%) 1
    Drug intolerance 1/1996 (0.1%) 1 2/2037 (0.1%) 2
    Fatigue 3/1996 (0.2%) 3 9/2037 (0.4%) 9
    Feeling abnormal 0/1996 (0%) 0 1/2037 (0%) 1
    Feeling cold 0/1996 (0%) 0 1/2037 (0%) 1
    Feeling hot 0/1996 (0%) 0 1/2037 (0%) 1
    Gait disturbance 1/1996 (0.1%) 1 0/2037 (0%) 0
    Hyperthermia 1/1996 (0.1%) 1 0/2037 (0%) 0
    Hypertrophy 1/1996 (0.1%) 1 0/2037 (0%) 0
    Inflammation 0/1996 (0%) 0 2/2037 (0.1%) 2
    Injection site haemorrhage 1/1996 (0.1%) 1 1/2037 (0%) 1
    Injection site induration 1/1996 (0.1%) 1 1/2037 (0%) 1
    Malaise 2/1996 (0.1%) 2 0/2037 (0%) 0
    Non-cardiac chest pain 2/1996 (0.1%) 2 1/2037 (0%) 1
    Oedema 2/1996 (0.1%) 2 1/2037 (0%) 1
    Oedema peripheral 9/1996 (0.5%) 9 14/2037 (0.7%) 15
    Pain 4/1996 (0.2%) 4 2/2037 (0.1%) 2
    Polyp 0/1996 (0%) 0 1/2037 (0%) 1
    Puncture site discharge 1/1996 (0.1%) 1 0/2037 (0%) 0
    Puncture site haemorrhage 2/1996 (0.1%) 2 7/2037 (0.3%) 7
    Puncture site pain 2/1996 (0.1%) 2 0/2037 (0%) 0
    Pyrexia 24/1996 (1.2%) 24 33/2037 (1.6%) 33
    Spinal pain 2/1996 (0.1%) 2 3/2037 (0.1%) 3
    Systemic inflammatory response syndrome 0/1996 (0%) 0 1/2037 (0%) 1
    Thrombosis in device 3/1996 (0.2%) 3 0/2037 (0%) 0
    Vessel puncture site haematoma 9/1996 (0.5%) 9 12/2037 (0.6%) 12
    Vessel puncture site haemorrhage 0/1996 (0%) 0 4/2037 (0.2%) 6
    Vessel puncture site pain 0/1996 (0%) 0 1/2037 (0%) 1
    Hepatobiliary disorders
    Biliary colic 0/1996 (0%) 0 1/2037 (0%) 1
    Cholecystitis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Cholecystitis chronic 1/1996 (0.1%) 1 0/2037 (0%) 0
    Cholelithiasis 1/1996 (0.1%) 1 1/2037 (0%) 1
    Gallbladder disorder 0/1996 (0%) 0 1/2037 (0%) 1
    Hepatic cirrhosis 0/1996 (0%) 0 1/2037 (0%) 1
    Hepatic cyst 0/1996 (0%) 0 1/2037 (0%) 1
    Hepatic steatosis 3/1996 (0.2%) 3 3/2037 (0.1%) 3
    Jaundice 0/1996 (0%) 0 1/2037 (0%) 1
    Liver disorder 0/1996 (0%) 0 1/2037 (0%) 1
    Immune system disorders
    Allergy to chemicals 1/1996 (0.1%) 1 0/2037 (0%) 0
    Contrast media allergy 1/1996 (0.1%) 1 1/2037 (0%) 1
    Drug hypersensitivity 1/1996 (0.1%) 1 2/2037 (0.1%) 2
    Hypersensitivity 1/1996 (0.1%) 1 1/2037 (0%) 1
    Iodine allergy 4/1996 (0.2%) 4 2/2037 (0.1%) 2
    Infections and infestations
    Asymptomatic bacteriuria 0/1996 (0%) 0 1/2037 (0%) 1
    Bronchitis 3/1996 (0.2%) 3 3/2037 (0.1%) 3
    Bronchopneumonia 0/1996 (0%) 0 1/2037 (0%) 1
    Candidiasis 0/1996 (0%) 0 1/2037 (0%) 1
    Cellulitis 0/1996 (0%) 0 1/2037 (0%) 1
    Cystitis 3/1996 (0.2%) 3 1/2037 (0%) 1
    Diverticulitis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Erysipelas 1/1996 (0.1%) 1 0/2037 (0%) 0
    Eye abscess 0/1996 (0%) 0 1/2037 (0%) 1
    Fungal skin infection 0/1996 (0%) 0 1/2037 (0%) 1
    Gastroenteritis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Genital infection fungal 1/1996 (0.1%) 1 0/2037 (0%) 0
    Gingivitis 0/1996 (0%) 0 1/2037 (0%) 1
    Groin infection 1/1996 (0.1%) 1 0/2037 (0%) 0
    Hepatitis a 1/1996 (0.1%) 1 0/2037 (0%) 0
    Hepatitis e 1/1996 (0.1%) 1 0/2037 (0%) 0
    Herpes zoster 0/1996 (0%) 0 1/2037 (0%) 1
    Infected skin ulcer 1/1996 (0.1%) 1 0/2037 (0%) 0
    Infection 1/1996 (0.1%) 1 2/2037 (0.1%) 2
    Influenza 1/1996 (0.1%) 1 1/2037 (0%) 1
    Labyrinthitis 0/1996 (0%) 0 1/2037 (0%) 1
    Leprosy 1/1996 (0.1%) 1 0/2037 (0%) 0
    Lobar pneumonia 0/1996 (0%) 0 1/2037 (0%) 1
    Lung infection 1/1996 (0.1%) 1 3/2037 (0.1%) 3
    Lymphangitis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Nasopharyngitis 3/1996 (0.2%) 3 1/2037 (0%) 1
    Nosocomial infection 0/1996 (0%) 0 1/2037 (0%) 1
    Oral fungal infection 1/1996 (0.1%) 1 0/2037 (0%) 0
    Pharyngitis 2/1996 (0.1%) 2 1/2037 (0%) 1
    Pneumonia 5/1996 (0.3%) 5 6/2037 (0.3%) 6
    Post procedural infection 1/1996 (0.1%) 1 0/2037 (0%) 0
    Respiratory tract infection 3/1996 (0.2%) 3 0/2037 (0%) 0
    Septic shock 0/1996 (0%) 0 1/2037 (0%) 1
    Staphylococcal infection 1/1996 (0.1%) 1 0/2037 (0%) 0
    Upper respiratory tract infection 0/1996 (0%) 0 4/2037 (0.2%) 4
    Urinary tract infection 10/1996 (0.5%) 10 10/2037 (0.5%) 10
    Viral diarrhoea 0/1996 (0%) 0 1/2037 (0%) 1
    Vulvovaginal mycotic infection 0/1996 (0%) 0 1/552 (0.2%) 1
    Injury, poisoning and procedural complications
    Anaemia postoperative 0/1996 (0%) 0 2/2037 (0.1%) 2
    Arterial restenosis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Arteriovenous graft aneurysm 0/1996 (0%) 0 1/2037 (0%) 1
    Cardiac function disturbance postoperative 0/1996 (0%) 0 1/2037 (0%) 1
    Cardiac procedure complication 2/1996 (0.1%) 2 3/2037 (0.1%) 3
    Contrast media reaction 1/1996 (0.1%) 1 0/2037 (0%) 0
    Contusion 14/1996 (0.7%) 14 15/2037 (0.7%) 16
    Coronary artery restenosis 0/1996 (0%) 0 1/2037 (0%) 1
    Dislocation of sternum 1/1996 (0.1%) 1 0/2037 (0%) 0
    Excoriation 0/1996 (0%) 0 2/2037 (0.1%) 2
    Face injury 1/1996 (0.1%) 1 0/2037 (0%) 0
    Facial bones fracture 0/1996 (0%) 0 1/2037 (0%) 1
    Fall 1/1996 (0.1%) 1 2/2037 (0.1%) 2
    Haematuria traumatic 0/1996 (0%) 0 1/2037 (0%) 1
    Head injury 0/1996 (0%) 0 1/2037 (0%) 1
    Incision site haematoma 2/1996 (0.1%) 2 0/2037 (0%) 0
    Incision site haemorrhage 1/1996 (0.1%) 1 0/2037 (0%) 0
    Laceration 0/1996 (0%) 0 1/2037 (0%) 1
    Overdose 2/1996 (0.1%) 2 2/2037 (0.1%) 2
    Periorbital haematoma 0/1996 (0%) 0 1/2037 (0%) 1
    Post procedural fistula 1/1996 (0.1%) 1 0/2037 (0%) 0
    Post procedural haematoma 3/1996 (0.2%) 3 0/2037 (0%) 0
    Post procedural haemorrhage 4/1996 (0.2%) 4 9/2037 (0.4%) 9
    Post procedural myocardial infarction 5/1996 (0.3%) 5 7/2037 (0.3%) 7
    Post procedural oedema 0/1996 (0%) 0 1/2037 (0%) 1
    Postoperative thoracic procedure complication 0/1996 (0%) 0 1/2037 (0%) 1
    Postoperative thrombosis 0/1996 (0%) 0 1/2037 (0%) 1
    Procedural haemorrhage 4/1996 (0.2%) 4 5/2037 (0.2%) 5
    Procedural hypotension 3/1996 (0.2%) 3 0/2037 (0%) 0
    Procedural pain 3/1996 (0.2%) 3 2/2037 (0.1%) 2
    Rib fracture 0/1996 (0%) 0 1/2037 (0%) 1
    Skin wound 1/1996 (0.1%) 1 0/2037 (0%) 0
    Subcutaneous haematoma 1/1996 (0.1%) 1 0/2037 (0%) 0
    Traumatic haemorrhage 1/1996 (0.1%) 1 0/2037 (0%) 0
    Vascular graft occlusion 0/1996 (0%) 0 1/2037 (0%) 1
    Vascular graft thrombosis 0/1996 (0%) 0 1/2037 (0%) 1
    Vascular pseudoaneurysm 3/1996 (0.2%) 3 3/2037 (0.1%) 3
    Wound haemorrhage 0/1996 (0%) 0 2/2037 (0.1%) 2
    Wound secretion 0/1996 (0%) 0 1/2037 (0%) 1
    Investigations
    Alanine aminotransferase increased 0/1996 (0%) 0 1/2037 (0%) 1
    Amylase increased 0/1996 (0%) 0 1/2037 (0%) 1
    Antibiotic resistant staphylococcus test positive 1/1996 (0.1%) 1 0/2037 (0%) 0
    Aortic bruit 1/1996 (0.1%) 1 1/2037 (0%) 1
    Arteriogram coronary 1/1996 (0.1%) 1 0/2037 (0%) 0
    Blood bilirubin decreased 0/1996 (0%) 0 1/2037 (0%) 1
    Blood creatine phosphokinase increased 7/1996 (0.4%) 7 6/2037 (0.3%) 6
    Blood creatine phosphokinase mb increased 4/1996 (0.2%) 4 2/2037 (0.1%) 2
    Blood creatinine increased 2/1996 (0.1%) 2 1/2037 (0%) 1
    Blood glucose increased 2/1996 (0.1%) 2 1/2037 (0%) 1
    Blood magnesium decreased 0/1996 (0%) 0 1/2037 (0%) 1
    Blood potassium decreased 1/1996 (0.1%) 1 1/2037 (0%) 1
    Blood pressure increased 1/1996 (0.1%) 1 4/2037 (0.2%) 4
    Blood triglycerides increased 0/1996 (0%) 0 1/2037 (0%) 1
    Blood urine 1/1996 (0.1%) 2 0/2037 (0%) 0
    Blood urine present 0/1996 (0%) 0 1/2037 (0%) 1
    Body temperature increased 2/1996 (0.1%) 2 2/2037 (0.1%) 2
    C-reactive protein increased 1/1996 (0.1%) 1 3/2037 (0.1%) 3
    Carbohydrate tolerance decreased 1/1996 (0.1%) 1 0/2037 (0%) 0
    Cardiac enzymes increased 16/1996 (0.8%) 16 19/2037 (0.9%) 19
    Cardiac murmur 2/1996 (0.1%) 2 3/2037 (0.1%) 3
    Central venous pressure increased 1/1996 (0.1%) 1 0/2037 (0%) 0
    Ejection fraction decreased 2/1996 (0.1%) 2 1/2037 (0%) 1
    Electrocardiogram qt prolonged 1/1996 (0.1%) 1 0/2037 (0%) 0
    Electrocardiogram st segment depression 1/1996 (0.1%) 1 0/2037 (0%) 0
    Electrocardiogram st segment elevation 0/1996 (0%) 0 1/2037 (0%) 1
    Electrophoresis protein abnormal 1/1996 (0.1%) 1 0/2037 (0%) 0
    Haemoglobin decreased 20/1996 (1%) 20 28/2037 (1.4%) 28
    Heart rate increased 1/1996 (0.1%) 1 0/2037 (0%) 0
    Hepatic enzyme increased 1/1996 (0.1%) 1 5/2037 (0.2%) 5
    Hepatitis c virus test positive 1/1996 (0.1%) 1 0/2037 (0%) 0
    Inflammatory marker increased 1/1996 (0.1%) 1 1/2037 (0%) 1
    Low density lipoprotein increased 2/1996 (0.1%) 2 0/2037 (0%) 0
    Oxygen saturation decreased 0/1996 (0%) 0 1/2037 (0%) 1
    Peripheral pulse decreased 1/1996 (0.1%) 1 0/2037 (0%) 0
    Platelet count decreased 2/1996 (0.1%) 2 2/2037 (0.1%) 2
    Prostatic specific antigen increased 0/1996 (0%) 0 1/1485 (0.1%) 1
    Transaminases increased 1/1996 (0.1%) 1 2/2037 (0.1%) 2
    Troponin i increased 4/1996 (0.2%) 4 4/2037 (0.2%) 4
    Troponin increased 3/1996 (0.2%) 3 4/2037 (0.2%) 4
    Urine output decreased 0/1996 (0%) 0 1/2037 (0%) 1
    Weight increased 0/1996 (0%) 0 1/2037 (0%) 1
    White blood cell count increased 2/1996 (0.1%) 2 0/2037 (0%) 0
    Metabolism and nutrition disorders
    Decreased appetite 1/1996 (0.1%) 1 1/2037 (0%) 1
    Diabetes mellitus 24/1996 (1.2%) 24 27/2037 (1.3%) 27
    Dyslipidaemia 27/1996 (1.4%) 27 22/2037 (1.1%) 22
    Fluid retention 0/1996 (0%) 0 1/2037 (0%) 1
    Glucose tolerance impaired 4/1996 (0.2%) 4 5/2037 (0.2%) 5
    Gout 3/1996 (0.2%) 3 3/2037 (0.1%) 3
    Hypercholesterolaemia 87/1996 (4.4%) 87 72/2037 (3.5%) 72
    Hyperglycaemia 4/1996 (0.2%) 4 6/2037 (0.3%) 6
    Hyperkalaemia 2/1996 (0.1%) 2 1/2037 (0%) 1
    Hyperlipidaemia 42/1996 (2.1%) 42 26/2037 (1.3%) 26
    Hypernatraemia 0/1996 (0%) 0 1/2037 (0%) 1
    Hypertriglyceridaemia 0/1996 (0%) 0 2/2037 (0.1%) 2
    Hyperuricaemia 4/1996 (0.2%) 4 5/2037 (0.2%) 5
    Hypo hdl cholesterolaemia 0/1996 (0%) 0 2/2037 (0.1%) 2
    Hypoglycaemia 2/1996 (0.1%) 2 2/2037 (0.1%) 2
    Hypokalaemia 18/1996 (0.9%) 18 14/2037 (0.7%) 14
    Hyponatraemia 1/1996 (0.1%) 1 0/2037 (0%) 0
    Impaired fasting glucose 1/1996 (0.1%) 1 1/2037 (0%) 1
    Lipid metabolism disorder 0/1996 (0%) 0 1/2037 (0%) 1
    Metabolic acidosis 0/1996 (0%) 0 1/2037 (0%) 1
    Obesity 5/1996 (0.3%) 5 2/2037 (0.1%) 2
    Overweight 1/1996 (0.1%) 1 1/2037 (0%) 1
    Type 2 diabetes mellitus 6/1996 (0.3%) 6 7/2037 (0.3%) 7
    Musculoskeletal and connective tissue disorders
    Arthralgia 3/1996 (0.2%) 3 7/2037 (0.3%) 7
    Arthritis 2/1996 (0.1%) 2 2/2037 (0.1%) 2
    Back pain 15/1996 (0.8%) 15 20/2037 (1%) 20
    Bone lesion 1/1996 (0.1%) 1 0/2037 (0%) 0
    Bone swelling 1/1996 (0.1%) 1 0/2037 (0%) 0
    Gouty arthritis 0/1996 (0%) 0 1/2037 (0%) 1
    Groin pain 1/1996 (0.1%) 1 5/2037 (0.2%) 5
    Intervertebral disc degeneration 1/1996 (0.1%) 1 1/2037 (0%) 1
    Intervertebral disc protrusion 0/1996 (0%) 0 2/2037 (0.1%) 2
    Joint swelling 2/1996 (0.1%) 2 0/2037 (0%) 0
    Muscle spasms 2/1996 (0.1%) 2 5/2037 (0.2%) 5
    Muscular weakness 0/1996 (0%) 0 4/2037 (0.2%) 4
    Musculoskeletal chest pain 0/1996 (0%) 0 3/2037 (0.1%) 3
    Musculoskeletal pain 7/1996 (0.4%) 7 6/2037 (0.3%) 6
    Myalgia 7/1996 (0.4%) 7 9/2037 (0.4%) 9
    Neck pain 2/1996 (0.1%) 2 1/2037 (0%) 1
    Osteoarthritis 2/1996 (0.1%) 2 1/2037 (0%) 1
    Pain in extremity 14/1996 (0.7%) 14 17/2037 (0.8%) 17
    Rheumatic disorder 0/1996 (0%) 0 1/2037 (0%) 1
    Spinal osteoarthritis 1/1996 (0.1%) 1 2/2037 (0.1%) 2
    Synovial cyst 0/1996 (0%) 0 1/2037 (0%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adrenal neoplasm 1/1996 (0.1%) 1 0/2037 (0%) 0
    Hypergammaglobulinaemia benign monoclonal 0/1996 (0%) 0 1/2037 (0%) 1
    Lung neoplasm 1/1996 (0.1%) 1 0/2037 (0%) 0
    Small cell lung cancer stage unspecified 0/1996 (0%) 0 1/2037 (0%) 1
    Nervous system disorders
    Akinesia 1/1996 (0.1%) 2 0/2037 (0%) 0
    Burning sensation 1/1996 (0.1%) 1 0/2037 (0%) 0
    Carotid arteriosclerosis 3/1996 (0.2%) 3 1/2037 (0%) 1
    Carotid artery disease 0/1996 (0%) 0 3/2037 (0.1%) 3
    Carotid artery stenosis 3/1996 (0.2%) 3 4/2037 (0.2%) 4
    Cerebellar syndrome 0/1996 (0%) 0 1/2037 (0%) 1
    Cerebrovascular accident 3/1996 (0.2%) 3 2/2037 (0.1%) 2
    Dizziness 11/1996 (0.6%) 11 14/2037 (0.7%) 14
    Drop attacks 1/1996 (0.1%) 2 0/2037 (0%) 0
    Dysarthria 1/1996 (0.1%) 1 1/2037 (0%) 1
    Headache 48/1996 (2.4%) 48 44/2037 (2.2%) 45
    Hypoaesthesia 1/1996 (0.1%) 1 1/2037 (0%) 1
    Hypotonia 1/1996 (0.1%) 1 2/2037 (0.1%) 2
    Ischaemic stroke 1/1996 (0.1%) 1 0/2037 (0%) 0
    Motor dysfunction 1/1996 (0.1%) 1 0/2037 (0%) 0
    Neuralgia 0/1996 (0%) 0 2/2037 (0.1%) 2
    Neuropathy peripheral 0/1996 (0%) 0 1/2037 (0%) 1
    Paraesthesia 1/1996 (0.1%) 1 2/2037 (0.1%) 2
    Presyncope 8/1996 (0.4%) 8 10/2037 (0.5%) 10
    Psychomotor hyperactivity 2/1996 (0.1%) 2 2/2037 (0.1%) 2
    Sciatica 0/1996 (0%) 0 2/2037 (0.1%) 2
    Sensory disturbance 0/1996 (0%) 0 1/2037 (0%) 1
    Somnolence 0/1996 (0%) 0 1/2037 (0%) 1
    Syncope 5/1996 (0.3%) 5 3/2037 (0.1%) 3
    Transient ischaemic attack 1/1996 (0.1%) 1 0/2037 (0%) 0
    Tremor 1/1996 (0.1%) 1 0/2037 (0%) 0
    Vertebral artery stenosis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Psychiatric disorders
    Agitation 1/1996 (0.1%) 1 3/2037 (0.1%) 3
    Alcoholism 0/1996 (0%) 0 1/2037 (0%) 1
    Anxiety 10/1996 (0.5%) 10 13/2037 (0.6%) 13
    Confusional state 0/1996 (0%) 0 6/2037 (0.3%) 6
    Delirium 0/1996 (0%) 0 2/2037 (0.1%) 2
    Depression 4/1996 (0.2%) 4 3/2037 (0.1%) 3
    Disorientation 2/1996 (0.1%) 2 3/2037 (0.1%) 4
    Hallucination 1/1996 (0.1%) 1 0/2037 (0%) 0
    Histrionic personality disorder 0/1996 (0%) 0 1/2037 (0%) 1
    Insomnia 6/1996 (0.3%) 6 3/2037 (0.1%) 3
    Libido disorder 1/1996 (0.1%) 1 0/2037 (0%) 0
    Mental disorder 1/1996 (0.1%) 1 0/2037 (0%) 0
    Panic disorder 1/1996 (0.1%) 1 0/2037 (0%) 0
    Sleep disorder 1/1996 (0.1%) 1 1/2037 (0%) 1
    Transient psychosis 2/1996 (0.1%) 2 1/2037 (0%) 1
    Renal and urinary disorders
    Cystitis haemorrhagic 1/1996 (0.1%) 1 0/2037 (0%) 0
    Dysuria 1/1996 (0.1%) 1 4/2037 (0.2%) 4
    Haematuria 6/1996 (0.3%) 6 9/2037 (0.4%) 9
    Haemoglobinuria 0/1996 (0%) 0 1/2037 (0%) 1
    Nephrolithiasis 3/1996 (0.2%) 3 0/2037 (0%) 0
    Nephropathy 1/1996 (0.1%) 1 0/2037 (0%) 0
    Nephropathy toxic 0/1996 (0%) 0 1/2037 (0%) 1
    Nephrotic syndrome 1/1996 (0.1%) 1 0/2037 (0%) 0
    Polyuria 1/1996 (0.1%) 1 0/2037 (0%) 0
    Renal colic 1/1996 (0.1%) 1 0/2037 (0%) 0
    Renal cyst 2/1996 (0.1%) 2 2/2037 (0.1%) 2
    Renal failure 9/1996 (0.5%) 9 8/2037 (0.4%) 8
    Renal failure acute 1/1996 (0.1%) 1 2/2037 (0.1%) 2
    Renal failure chronic 6/1996 (0.3%) 6 5/2037 (0.2%) 5
    Strangury 1/1996 (0.1%) 1 0/2037 (0%) 0
    Urethral haemorrhage 1/1996 (0.1%) 1 0/2037 (0%) 0
    Urinary retention 4/1996 (0.2%) 5 2/2037 (0.1%) 2
    Reproductive system and breast disorders
    Balanoposthitis 1/1438 (0.1%) 1 0/1485 (0%) 0
    Benign prostatic hyperplasia 0/1438 (0%) 0 2/1485 (0.1%) 2
    Breast haematoma 1/1996 (0.1%) 1 1/2037 (0%) 1
    Epididymal cyst 1/1438 (0.1%) 1 0/1485 (0%) 0
    Epididymitis 1/1438 (0.1%) 1 0/1485 (0%) 0
    Erectile dysfunction 4/1438 (0.3%) 4 1/1485 (0.1%) 1
    Gynaecomastia 1/1438 (0.1%) 1 1/1485 (0.1%) 1
    Ovarian cyst 0/558 (0%) 0 2/552 (0.4%) 2
    Penis disorder 0/1438 (0%) 0 1/1485 (0.1%) 1
    Prostatic calcification 1/1438 (0.1%) 1 0/1485 (0%) 0
    Testicular oedema 0/1438 (0%) 0 1/1485 (0.1%) 1
    Vaginal haemorrhage 1/558 (0.2%) 1 2/552 (0.4%) 2
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm 2/1996 (0.1%) 2 0/2037 (0%) 0
    Bronchostenosis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Chronic obstructive pulmonary disease 7/1996 (0.4%) 7 2/2037 (0.1%) 2
    Cough 15/1996 (0.8%) 15 22/2037 (1.1%) 22
    Dysphonia 1/1996 (0.1%) 1 1/2037 (0%) 1
    Dyspnoea 18/1996 (0.9%) 19 21/2037 (1%) 21
    Dyspnoea at rest 1/1996 (0.1%) 1 0/2037 (0%) 0
    Dyspnoea exertional 2/1996 (0.1%) 2 5/2037 (0.2%) 5
    Emphysema 1/1996 (0.1%) 1 1/2037 (0%) 1
    Epistaxis 28/1996 (1.4%) 30 38/2037 (1.9%) 48
    Haemoptysis 1/1996 (0.1%) 1 1/2037 (0%) 1
    Haemothorax 0/1996 (0%) 0 1/2037 (0%) 1
    Hiccups 1/1996 (0.1%) 1 0/2037 (0%) 0
    Hydrothorax 1/1996 (0.1%) 1 0/2037 (0%) 0
    Lung consolidation 1/1996 (0.1%) 1 0/2037 (0%) 0
    Lung disorder 0/1996 (0%) 0 1/2037 (0%) 1
    Lung infiltration 0/1996 (0%) 0 1/2037 (0%) 1
    Oropharyngeal pain 1/1996 (0.1%) 1 2/2037 (0.1%) 2
    Pharyngeal haemorrhage 0/1996 (0%) 0 1/2037 (0%) 2
    Pleural effusion 5/1996 (0.3%) 5 3/2037 (0.1%) 3
    Pleurisy 1/1996 (0.1%) 1 0/2037 (0%) 0
    Pneumonitis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Pulmonary congestion 0/1996 (0%) 0 1/2037 (0%) 2
    Pulmonary embolism 1/1996 (0.1%) 1 5/2037 (0.2%) 5
    Pulmonary fibrosis 1/1996 (0.1%) 1 1/2037 (0%) 1
    Pulmonary haemorrhage 1/1996 (0.1%) 3 0/2037 (0%) 0
    Pulmonary hypertension 4/1996 (0.2%) 4 1/2037 (0%) 1
    Pulmonary oedema 4/1996 (0.2%) 5 4/2037 (0.2%) 4
    Rales 2/1996 (0.1%) 2 0/2037 (0%) 0
    Respiratory tract haemorrhage 0/1996 (0%) 0 1/2037 (0%) 1
    Rhonchi 1/1996 (0.1%) 1 0/2037 (0%) 0
    Sleep apnoea syndrome 3/1996 (0.2%) 3 0/2037 (0%) 0
    Sneezing 0/1996 (0%) 0 1/2037 (0%) 1
    Sputum discoloured 1/1996 (0.1%) 1 0/2037 (0%) 0
    Skin and subcutaneous tissue disorders
    Blister 2/1996 (0.1%) 2 1/2037 (0%) 1
    Cold sweat 0/1996 (0%) 0 1/2037 (0%) 1
    Dermatitis 0/1996 (0%) 0 2/2037 (0.1%) 2
    Dermatitis allergic 3/1996 (0.2%) 3 4/2037 (0.2%) 4
    Dermatitis contact 0/1996 (0%) 0 1/2037 (0%) 1
    Dry skin 1/1996 (0.1%) 1 0/2037 (0%) 0
    Ecchymosis 12/1996 (0.6%) 12 10/2037 (0.5%) 12
    Eczema 3/1996 (0.2%) 3 0/2037 (0%) 0
    Erythema 11/1996 (0.6%) 11 6/2037 (0.3%) 6
    Hyperhidrosis 2/1996 (0.1%) 2 4/2037 (0.2%) 4
    Increased tendency to bruise 1/1996 (0.1%) 1 1/2037 (0%) 1
    Macule 1/1996 (0.1%) 1 0/2037 (0%) 0
    Palmar erythema 0/1996 (0%) 0 1/2037 (0%) 1
    Petechiae 0/1996 (0%) 0 2/2037 (0.1%) 2
    Prurigo 0/1996 (0%) 0 1/2037 (0%) 1
    Pruritus 3/1996 (0.2%) 3 3/2037 (0.1%) 3
    Rash 13/1996 (0.7%) 13 4/2037 (0.2%) 4
    Scar pain 1/1996 (0.1%) 1 0/2037 (0%) 0
    Skin irritation 1/1996 (0.1%) 1 0/2037 (0%) 0
    Skin lesion 1/1996 (0.1%) 1 0/2037 (0%) 0
    Skin ulcer 1/1996 (0.1%) 1 0/2037 (0%) 0
    Subcutaneous emphysema 0/1996 (0%) 0 1/2037 (0%) 1
    Urticaria 3/1996 (0.2%) 3 2/2037 (0.1%) 2
    Xanthoma 1/1996 (0.1%) 1 0/2037 (0%) 0
    Surgical and medical procedures
    Bladder catheter removal 0/1996 (0%) 0 1/2037 (0%) 1
    Blood product transfusion 1/1996 (0.1%) 1 0/2037 (0%) 0
    Cardiac pacemaker insertion 0/1996 (0%) 0 3/2037 (0.1%) 3
    Carotid angioplasty 1/1996 (0.1%) 1 0/2037 (0%) 0
    Coronary angioplasty 0/1996 (0%) 0 1/2037 (0%) 1
    Coronary artery bypass 2/1996 (0.1%) 2 5/2037 (0.2%) 5
    Coronary revascularisation 0/1996 (0%) 0 1/2037 (0%) 1
    Dialysis 0/1996 (0%) 0 1/2037 (0%) 1
    Heart valve operation 0/1996 (0%) 0 1/2037 (0%) 1
    Implantable defibrillator insertion 1/1996 (0.1%) 1 1/2037 (0%) 1
    Packed red blood cell transfusion 0/1996 (0%) 0 1/2037 (0%) 1
    Percutaneous coronary intervention 14/1996 (0.7%) 14 8/2037 (0.4%) 8
    Platelet transfusion 1/1996 (0.1%) 1 0/2037 (0%) 0
    Thromboembolectomy 0/1996 (0%) 0 1/2037 (0%) 1
    Vascular disorders
    Aneurysm 0/1996 (0%) 0 1/2037 (0%) 1
    Angiopathy 1/1996 (0.1%) 1 0/2037 (0%) 0
    Aortic aneurysm 0/1996 (0%) 0 1/2037 (0%) 1
    Aortic arteriosclerosis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Aortic calcification 1/1996 (0.1%) 1 0/2037 (0%) 0
    Aortic dilatation 1/1996 (0.1%) 1 3/2037 (0.1%) 3
    Aortic disorder 1/1996 (0.1%) 1 0/2037 (0%) 0
    Aortic stenosis 5/1996 (0.3%) 5 3/2037 (0.1%) 3
    Aortic thrombosis 0/1996 (0%) 0 1/2037 (0%) 1
    Arterial haemorrhage 0/1996 (0%) 0 1/2037 (0%) 1
    Arterial stenosis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Arteriosclerosis 1/1996 (0.1%) 1 0/2037 (0%) 0
    Artery dissection 0/1996 (0%) 0 1/2037 (0%) 1
    Blood pressure fluctuation 1/1996 (0.1%) 1 0/2037 (0%) 0
    Deep vein thrombosis 0/1996 (0%) 0 2/2037 (0.1%) 2
    Embolism 1/1996 (0.1%) 1 1/2037 (0%) 1
    Femoral artery dissection 1/1996 (0.1%) 1 0/2037 (0%) 0
    Flushing 1/1996 (0.1%) 1 1/2037 (0%) 1
    Haematoma 57/1996 (2.9%) 62 96/2037 (4.7%) 97
    Haemodynamic instability 2/1996 (0.1%) 2 0/2037 (0%) 0
    Haemorrhage 10/1996 (0.5%) 10 13/2037 (0.6%) 13
    Hypertension 88/1996 (4.4%) 88 90/2037 (4.4%) 90
    Hypertensive crisis 1/1996 (0.1%) 1 1/2037 (0%) 1
    Hypotension 23/1996 (1.2%) 23 28/2037 (1.4%) 29
    Ischaemia 2/1996 (0.1%) 2 1/2037 (0%) 1
    Macroangiopathy 1/1996 (0.1%) 1 0/2037 (0%) 0
    Orthostatic hypotension 2/1996 (0.1%) 2 1/2037 (0%) 1
    Peripheral arterial occlusive disease 4/1996 (0.2%) 4 4/2037 (0.2%) 4
    Peripheral artery dissection 0/1996 (0%) 0 2/2037 (0.1%) 2
    Peripheral artery thrombosis 0/1996 (0%) 0 1/2037 (0%) 1
    Peripheral coldness 0/1996 (0%) 0 2/2037 (0.1%) 2
    Peripheral embolism 1/1996 (0.1%) 1 0/2037 (0%) 0
    Phlebitis 4/1996 (0.2%) 4 3/2037 (0.1%) 3
    Raynaud's phenomenon 1/1996 (0.1%) 1 1/2037 (0%) 1
    Reperfusion injury 3/1996 (0.2%) 3 3/2037 (0.1%) 3
    Thrombophlebitis 0/1996 (0%) 0 1/2037 (0%) 1
    Thrombophlebitis superficial 0/1996 (0%) 0 1/2037 (0%) 1
    Thrombosis 6/1996 (0.3%) 7 4/2037 (0.2%) 4
    Varicose vein ruptured 0/1996 (0%) 0 1/2037 (0%) 1
    Vascular occlusion 2/1996 (0.1%) 2 1/2037 (0%) 1
    Vasospasm 2/1996 (0.1%) 3 2/2037 (0.1%) 2
    Venous thrombosis 0/1996 (0%) 0 1/2037 (0%) 1
    Venous thrombosis limb 1/1996 (0.1%) 1 0/2037 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT01015287
    Other Study ID Numbers:
    • 12918
    • H7T-MC-TADF
    First Posted:
    Nov 18, 2009
    Last Update Posted:
    Feb 28, 2014
    Last Verified:
    Jan 1, 2014