ATLANTIC: A 30 Day Study to Evaluate Efficacy and Safety of Pre-hospital vs. In-hospital Initiation of Ticagrelor Therapy in STEMI Patients Planned for Percutaneous Coronary Intervention (PCI)
Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT01347580
Collaborator
(none)
1,875
101
2
26
18.6
0.7
Study Details
Study Description
Brief Summary
The aim of this study is to determine whether initiation of ticagrelor as early as in the ambulance setting leads to a rapid reperfusion of the infarct-related artery therefore facilitating the Percutaneous Coronary Intervention (PCI) and optimizing the outcome for the patient.
The study will assess the efficacy and safety of pre-hospital compared to in-hospital administration of ticagrelor in co-administration with aspirin, on restoring the blood flow in the occluded heart artery and improving the myocardial perfusion in patients suffering from myocardial infarction and planned to have a PCI. Patients can be randomised in either one of the 2 arms:
re-hospital ticagrelor arm: Patients will receive a loading dose of 180 mg ticagrelor for the pre-hospital administration and placebo for in-hospital administration.
or In-hospital ticagrelor arm: Patients will receive a placebo for pre-hospital administration and 180 mg ticagrelor loading dose for in-hospital administration.
Patients are initially managed by ambulance physician/personnel in pre hospital settings. They are then transferred into a Catheterization room to undergo a PCI.
After the administration of the loading dose of ticagrelor (double blind), patients will continue on ticagrelor 90 mg bid and be followed in study for 30 days post randomisation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1875 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A 30 Day International, Randomized, Parallel-group, Double-blind, Placebo-controlled Phase IV Study to Evaluate Efficacy and Safety of Pre-hospital vs. In-hospital Initiation of Ticagrelor Therapy in STEMI Patients Planned for PCI.
Study Start Date
:
Sep 1, 2011
Actual Primary Completion Date
:
Nov 1, 2013
Actual Study Completion Date
:
Nov 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ticagrelor Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. |
Drug: Ticagrelor
Oral Ticagrelor loading dose (180 mg) followed by matching placebo
|
| Experimental: Placebo Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. |
Drug: Placebo
Placebo followed by oral Ticagrelor loading dose (180 mg)
|
Outcome Measures
Primary Outcome Measures
- Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 of MI Culprit Vessel at Initial Angiography (Co-primary Endpoint) [At initial angiography, pre PCI]
(TIMI) flow grade classification is used to assess coronary blood flow in acute coronary syndromes. grade 0:no reperfusion, grade 1: penetration without perfusion, grade 2: Partial reperfusion, grade 3: complete perfusion.
- ST-segment Elevation Resolution Pre PCI ≥70% (Co-primary Endpoint) [Between baseline and PCI]
ST segment elevation resolution is the mean ST elevation pre-hospital minus the mean STelevation pre-PCI divided by the mean ST elevation pre-hospital. It is expressed as a percentage and split in 2 categories , complete (≥70%) versus incomplete (<70%) resolution.
Secondary Outcome Measures
- 1st Composite Clinical Endpoint [during the 30 days of treatment]
death/MI/stroke/urgent revascularization/stent thrombosis. Adjudicated events except death
- 2nd Composite Clinical Endpoint [within 30 days of study]
Death/MI/urgent revascularization. Adjudicated events except death
- Definite Stent Thrombosis [during 30 days of treatment]
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. It is an adjudicated endpoint
- TIMI Flow Grade 3 Post -PCI [at coroangiography post-PCI]
TIMI) flow grade 3 is complete perfusion post-PCI.
- ST Segment Elevation Resolution Post-PCI >= 70% [Between baseline and ECG 60 mn post-PCI]
ST segment elevation resolution post PCI >=70% is defined as complete resolution
- Thrombotic Bail-out With GPIIb/IIIa Inhibitors at Initial PCI [during PCI]
Glycoprotein (GP) IIb/IIIa inhibitors are often used as a rescue or bailout therapy to manage complications arising during percutaneous coronary intervention.
- Major Bleeds Within 48 Hours [within 48 hours of first dose]
non CABG related bleeds, (PLATO definition) include Life threatening and other major bleeds
- Minor and Major Bleedings Within 48 Hours [within 48 hours of first dose]
non CABG related bleeds (PLATO definition)
- Major Bleeds After 48 Hours [after 48hours post-first dose]
non CABG related bleeds (PLATO definition) include life threatening and other major bleedings
- Minor and Major Bleeds After 48 Hours [after 48 hours post first dose]
non CABG related bleeds (PLATO definition)
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Women must not be of child-bearing potential (1 year post-menopausal or surgically sterile).
-
Symptoms of acute MI of more than 30 min but less than 6 hours
-
New persistent ST-segment elevation ≥ 1 mm in two or more contiguous electrocardiogram (ECG) leads.
Exclusion Criteria:
-
Expected time to 1st PCI balloon inflation in the hospital, from the qualifying ECG is more than 120 minutes
-
Contraindication to ticagrelor (refer to SmPC)
-
Concomitant medication that may increase the risk of bleeding [e.g non steroidal anti-inflammatory drugs (NSAIDs), oral anticoagulant and / or fibrinolytics, planned or administered 24 hours before randomization]
-
Any of the following conditions in the absence of a functioning implanted pacemaker: known SSS, second or third degree AVB, or documented syncope of suspected bradycardic origin.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Algiers | Algeria | ||
| 2 | Research Site | Blida | Algeria | ||
| 3 | Research Site | Herston | Australia | ||
| 4 | Research Site | Southport | Australia | ||
| 5 | Research Site | Woolloongabba | Australia | ||
| 6 | Research Site | Graz | Austria | ||
| 7 | Research Site | Innsbruck | Austria | ||
| 8 | Research Site | Wien | Austria | ||
| 9 | Research Site | Halifax | Nova Scotia | Canada | |
| 10 | Research Site | Newmarket | Ontario | Canada | |
| 11 | Research Site | Scarborough | Ontario | Canada | |
| 12 | Research Site | Regina | Saskatchewan | Canada | |
| 13 | Research Site | Aalborg | Denmark | ||
| 14 | Research Site | Odense C | Denmark | ||
| 15 | Research Site | Århus | Denmark | ||
| 16 | Research Site | Aubervilliers | France | ||
| 17 | Research Site | Besançon | France | ||
| 18 | Research Site | Boulogne Billancourt | France | ||
| 19 | Research Site | Bourges | France | ||
| 20 | Research Site | Bron | France | ||
| 21 | Research Site | Chateauroux | France | ||
| 22 | Research Site | Corbeil Essonnes Cedex | France | ||
| 23 | Research Site | Creteil | France | ||
| 24 | Research Site | Dijon | France | ||
| 25 | Research Site | LAGNY SUR MARNE cedex | France | ||
| 26 | Research Site | Le Chesnay | France | ||
| 27 | Research Site | Le Coudray | France | ||
| 28 | Research Site | Lyon Cedex 04 | France | ||
| 29 | Research Site | Lyon | France | ||
| 30 | Research Site | MARSEILLE cedex 15 | France | ||
| 31 | Research Site | Marseille | France | ||
| 32 | Research Site | Massy | France | ||
| 33 | Research Site | Melun | France | ||
| 34 | Research Site | Montauban | France | ||
| 35 | Research Site | Montfermeil | France | ||
| 36 | Research Site | MONTREUIL Cedex | France | ||
| 37 | Research Site | Neuilly Sur Seine | France | ||
| 38 | Research Site | Nimes | France | ||
| 39 | Research Site | Paris Cedex 13 | France | ||
| 40 | Research Site | PARIS Cedex 15 | France | ||
| 41 | Research Site | Paris | France | ||
| 42 | Research Site | PESSAC Cedex | France | ||
| 43 | Research Site | Quincy sous Sénart | France | ||
| 44 | Research Site | Rouen Cedex | France | ||
| 45 | Research Site | Strasbourg | France | ||
| 46 | Research Site | TOURS Cedex 9 | France | ||
| 47 | Research Site | TOURS cedex | France | ||
| 48 | Research Site | VANNES cedex | France | ||
| 49 | Research Site | Bad Friedrichshall | Germany | ||
| 50 | Research Site | Bad Nauheim | Germany | ||
| 51 | Research Site | Darmstadt | Germany | ||
| 52 | Research Site | Esslingen | Germany | ||
| 53 | Research Site | Freiburg | Germany | ||
| 54 | Research Site | Gießen | Germany | ||
| 55 | Research Site | Hannover | Germany | ||
| 56 | Research Site | Ludwigshafen | Germany | ||
| 57 | Research Site | Lüdenscheid | Germany | ||
| 58 | Research Site | Mainz | Germany | ||
| 59 | Research Site | Merseburg | Germany | ||
| 60 | Research Site | Wuppertal | Germany | ||
| 61 | Research Site | Budapest | Hungary | ||
| 62 | Research Site | Debrecen | Hungary | ||
| 63 | Research Site | Pécs | Hungary | ||
| 64 | Research Site | Szeged | Hungary | ||
| 65 | Research Site | Arezzo | Italy | ||
| 66 | Research Site | Ascoli Piceno | Italy | ||
| 67 | Research Site | Cona | Italy | ||
| 68 | Research Site | Forlì | Italy | ||
| 69 | Research Site | Genova | Italy | ||
| 70 | Research Site | Grosseto | Italy | ||
| 71 | Research Site | Massa | Italy | ||
| 72 | Research Site | Seriate | Italy | ||
| 73 | Research Site | Siena | Italy | ||
| 74 | Research Site | Alkmaar | Netherlands | ||
| 75 | Research Site | Arnhem | Netherlands | ||
| 76 | Research Site | Den Bosch | Netherlands | ||
| 77 | Research Site | Terneuzen | Netherlands | ||
| 78 | Research Site | A Coruña | Spain | ||
| 79 | Research Site | Alicante | Spain | ||
| 80 | Research Site | Badalona | Spain | ||
| 81 | Research Site | Barcelona | Spain | ||
| 82 | Research Site | Hospitalet de Llobregat(Barcel | Spain | ||
| 83 | Research Site | Madrid | Spain | ||
| 84 | Research Site | Málaga | Spain | ||
| 85 | Research Site | Santiago(A Coruña) | Spain | ||
| 86 | Research Site | Sevilla | Spain | ||
| 87 | Research Site | Vigo(Pontevedra) | Spain | ||
| 88 | Research Site | Gävle | Sweden | ||
| 89 | Research Site | Linköping | Sweden | ||
| 90 | Research Site | Uppsala | Sweden | ||
| 91 | Research Site | Örebro | Sweden | ||
| 92 | Research Site | Ashford | United Kingdom | ||
| 93 | Research Site | Belfast | United Kingdom | ||
| 94 | Research Site | Cambridge | United Kingdom | ||
| 95 | Research Site | Coventry | United Kingdom | ||
| 96 | Research Site | Eastbourne | United Kingdom | ||
| 97 | Research Site | Hastings | United Kingdom | ||
| 98 | Research Site | Middlesborough | United Kingdom | ||
| 99 | Research Site | Newcastle-Upon-Tyne | United Kingdom | ||
| 100 | Research Site | Norwich | United Kingdom | ||
| 101 | Research Site | Sheffield | United Kingdom |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Study Director: Dr Judith Hsia, MD, AstraZeneca
- Principal Investigator: Pr Gilles Montalescot, Pitie Salpetriere Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01347580
Other Study ID Numbers:
- D5130L00006
First Posted:
May 4, 2011
Last Update Posted:
Jul 22, 2015
Last Verified:
Jul 1, 2015
Keywords provided by AstraZeneca
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Patients were randomized in pre-hospital settings at 102 Emergency Medical Services between September 2011 and October 2013. 1875 patients were recruited in the study, 1862 consented patients were randomized. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Pre-hospital Ticagrelor | In-hospital Ticagrelor |
|---|---|---|
| Arm/Group Description | Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. | Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. |
| Period Title: Overall Study | ||
| STARTED | 909 | 953 |
| Modified Intent to Treat Population | 906 | 952 |
| Safety Population | 908 | 950 |
| COMPLETED | 844 | 897 |
| NOT COMPLETED | 65 | 56 |
Baseline Characteristics
| Arm/Group Title | Pre-hospital Ticagrelor | In-hospital Ticagrelor | Total |
|---|---|---|---|
| Arm/Group Description | Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. | Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. | Total of all reporting groups |
| Overall Participants | 909 | 953 | 1862 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Years |
60.6
(12.38)
|
61.0
(12.49)
|
60.8
(12.43)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
173
19%
|
196
20.6%
|
369
19.8%
|
| Male |
736
81%
|
757
79.4%
|
1493
80.2%
|
| Diabetes mellitus (patients) [Number] | |||
| yes |
115
|
138
|
253
|
| no/unknown |
794
|
815
|
1609
|
| TIMI risk score (patients) [Number] | |||
| 0-2 |
552
|
573
|
1125
|
| 3-6 |
337
|
365
|
702
|
| >6 |
20
|
15
|
35
|
| Killip class (patients) [Number] | |||
| I |
819
|
862
|
1681
|
| II, III, IV |
51
|
43
|
94
|
| unknown |
39
|
48
|
87
|
| First medical contact (patients) [Number] | |||
| in ambulance |
689
|
723
|
1412
|
| in emergency department |
220
|
230
|
450
|
| PCI (Patients) [Number] | |||
| yes |
800
|
830
|
1630
|
| no |
109
|
123
|
232
|
| type of PCI (patients) [Number] | |||
| with stent |
760
|
776
|
1536
|
| without stent |
40
|
54
|
94
|
| Time between the 2 loading doses (minutes) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [minutes] |
32
|
30
|
31
|
Outcome Measures
| Title | Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 of MI Culprit Vessel at Initial Angiography (Co-primary Endpoint) |
|---|---|
| Description | (TIMI) flow grade classification is used to assess coronary blood flow in acute coronary syndromes. grade 0:no reperfusion, grade 1: penetration without perfusion, grade 2: Partial reperfusion, grade 3: complete perfusion. |
| Time Frame | At initial angiography, pre PCI |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT, on patients with non missing values |
| Arm/Group Title | Pre-hospital Ticagrelor | In-hospital Ticagrelor |
|---|---|---|
| Arm/Group Description | Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. | Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. |
| Measure Participants | 824 | 856 |
| Number [patients] |
143
|
145
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pre-hospital Ticagrelor, In-hospital Ticagrelor |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8214 |
| Comments | pvalue at 0.025 , adjusted for multiple comparisons | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.030 | |
| Confidence Interval |
(2-Sided) 95% 0.799 to 1.327 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | ST-segment Elevation Resolution Pre PCI ≥70% (Co-primary Endpoint) |
|---|---|
| Description | ST segment elevation resolution is the mean ST elevation pre-hospital minus the mean STelevation pre-PCI divided by the mean ST elevation pre-hospital. It is expressed as a percentage and split in 2 categories , complete (≥70%) versus incomplete (<70%) resolution. |
| Time Frame | Between baseline and PCI |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT, on patients with non missing values |
| Arm/Group Title | Pre-hospital Ticagrelor | In-hospital Ticagrelor |
|---|---|---|
| Arm/Group Description | Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. | Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. |
| Measure Participants | 774 | 824 |
| Number [patients] |
102
|
102
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pre-hospital Ticagrelor, In-hospital Ticagrelor |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6322 |
| Comments | P value at 0.025 adjusted for multiple comparisons | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.074 | |
| Confidence Interval |
(2-Sided) 95% 0.801 to 1.441 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | 1st Composite Clinical Endpoint |
|---|---|
| Description | death/MI/stroke/urgent revascularization/stent thrombosis. Adjudicated events except death |
| Time Frame | during the 30 days of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT |
| Arm/Group Title | Pre-hospital Ticagrelor | In-hospital Ticagrelor |
|---|---|---|
| Arm/Group Description | Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. | Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. |
| Measure Participants | 906 | 952 |
| Number [patients] |
41
|
42
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pre-hospital Ticagrelor, In-hospital Ticagrelor |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9056 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.027 | |
| Confidence Interval |
(2-Sided) 95% 0.661 to 1.595 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | 2nd Composite Clinical Endpoint |
|---|---|
| Description | Death/MI/urgent revascularization. Adjudicated events except death |
| Time Frame | within 30 days of study |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT |
| Arm/Group Title | Pre-hospital Ticagrelor | In-hospital Ticagrelor |
|---|---|---|
| Arm/Group Description | Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. | Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. |
| Measure Participants | 906 | 952 |
| Number [patients] |
39
|
34
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pre-hospital Ticagrelor, In-hospital Ticagrelor |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4168 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.215 | |
| Confidence Interval |
(2-Sided) 95% 0.760 to 1.942 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Definite Stent Thrombosis |
|---|---|
| Description | Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. It is an adjudicated endpoint |
| Time Frame | during 30 days of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT |
| Arm/Group Title | Pre-hospital Ticagrelor | In-hospital Ticagrelor |
|---|---|---|
| Arm/Group Description | Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. | Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. |
| Measure Participants | 906 | 952 |
| Number [patients] |
2
|
11
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pre-hospital Ticagrelor, In-hospital Ticagrelor |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0307 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.189 | |
| Confidence Interval |
(2-Sided) 95% 0.042 to 0.856 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | TIMI Flow Grade 3 Post -PCI |
|---|---|
| Description | TIMI) flow grade 3 is complete perfusion post-PCI. |
| Time Frame | at coroangiography post-PCI |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT, on patients with non missing TIMI flow grade values |
| Arm/Group Title | Pre-hospital Ticagrelor | In-hospital Ticagrelor |
|---|---|---|
| Arm/Group Description | Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. | Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. |
| Measure Participants | 760 | 784 |
| Number [patients] |
625
|
630
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pre-hospital Ticagrelor, In-hospital Ticagrelor |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.344 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.132 | |
| Confidence Interval |
(2-Sided) 95% 0.876 to 1.462 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | ST Segment Elevation Resolution Post-PCI >= 70% |
|---|---|
| Description | ST segment elevation resolution post PCI >=70% is defined as complete resolution |
| Time Frame | Between baseline and ECG 60 mn post-PCI |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT on patients with non missing ECG values |
| Arm/Group Title | Pre-hospital Ticagrelor | In-hospital Ticagrelor |
|---|---|---|
| Arm/Group Description | Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. | Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. |
| Measure Participants | 713 | 743 |
| Number [patients] |
410
|
390
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pre-hospital Ticagrelor |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0547 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.225 | |
| Confidence Interval |
(2-Sided) 95% 0.996 to 1.506 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Thrombotic Bail-out With GPIIb/IIIa Inhibitors at Initial PCI |
|---|---|
| Description | Glycoprotein (GP) IIb/IIIa inhibitors are often used as a rescue or bailout therapy to manage complications arising during percutaneous coronary intervention. |
| Time Frame | during PCI |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT |
| Arm/Group Title | Pre-hospital Ticagrelor | In-hospital Ticagrelor |
|---|---|---|
| Arm/Group Description | Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. | Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. |
| Measure Participants | 906 | 952 |
| Number [patients] |
78
|
100
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pre-hospital Ticagrelor, In-hospital Ticagrelor |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1660 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.803 | |
| Confidence Interval |
(2-Sided) 95% 0.588 to 1.096 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Major Bleeds Within 48 Hours |
|---|---|
| Description | non CABG related bleeds, (PLATO definition) include Life threatening and other major bleeds |
| Time Frame | within 48 hours of first dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety |
| Arm/Group Title | Pre-hospital Ticagrelor | In-hospital Ticagrelor |
|---|---|---|
| Arm/Group Description | Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. | Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. |
| Measure Participants | 908 | 950 |
| Number [patients] |
16
|
15
|
| Title | Minor and Major Bleedings Within 48 Hours |
|---|---|
| Description | non CABG related bleeds (PLATO definition) |
| Time Frame | within 48 hours of first dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety |
| Arm/Group Title | Pre-hospital Ticagrelor | In-hospital Ticagrelor |
|---|---|---|
| Arm/Group Description | Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. | Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. |
| Measure Participants | 908 | 950 |
| Number [patients] |
24
|
24
|
| Title | Major Bleeds After 48 Hours |
|---|---|
| Description | non CABG related bleeds (PLATO definition) include life threatening and other major bleedings |
| Time Frame | after 48hours post-first dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| safety |
| Arm/Group Title | Pre-hospital Ticagrelor | In-hospital Ticagrelor |
|---|---|---|
| Arm/Group Description | Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. | Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. |
| Measure Participants | 908 | 950 |
| Number [patients] |
11
|
11
|
| Title | Minor and Major Bleeds After 48 Hours |
|---|---|
| Description | non CABG related bleeds (PLATO definition) |
| Time Frame | after 48 hours post first dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| safety |
| Arm/Group Title | Pre-hospital Ticagrelor | In-hospital Ticagrelor |
|---|---|---|
| Arm/Group Description | Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. | Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. |
| Measure Participants | 908 | 950 |
| Number [patients] |
18
|
16
|
Adverse Events
| Time Frame | within 30 days of study | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Actual Treatment Safety analysis set concerns 1858 patients - Ticagrelor pre-hosp:908 and Ticagrelor in-hosp: 950. 4 patients receiveived study medication not according to randomization assignment | |||
| Arm/Group Title | Ticagrelor In-Hosp | Ticagrelor Pre-Hosp | ||
| Arm/Group Description | Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. | Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. | ||
All Cause Mortality |
||||
| Ticagrelor In-Hosp | Ticagrelor Pre-Hosp | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Ticagrelor In-Hosp | Ticagrelor Pre-Hosp | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 143/950 (15.1%) | 140/908 (15.4%) | ||
| Blood and lymphatic system disorders | ||||
| ANAEMIA | 2/950 (0.2%) | 2 | 1/908 (0.1%) | 1 |
| LEUKOCYTOSIS | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| Cardiac disorders | ||||
| ACUTE MYOCARDIAL INFARCTION | 1/950 (0.1%) | 1 | 1/908 (0.1%) | 1 |
| ANGINA PECTORIS | 2/950 (0.2%) | 2 | 3/908 (0.3%) | 3 |
| ANGINA UNSTABLE | 1/950 (0.1%) | 1 | 1/908 (0.1%) | 1 |
| AORTIC VALVE INCOMPETENCE | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| ARRHYTHMIA | 1/950 (0.1%) | 1 | 1/908 (0.1%) | 1 |
| ARTERIOSPASM CORONARY | 2/950 (0.2%) | 2 | 0/908 (0%) | 0 |
| ATRIAL FIBRILLATION | 2/950 (0.2%) | 2 | 4/908 (0.4%) | 4 |
| ATRIOVENTRICULAR BLOCK COMPLETE | 3/950 (0.3%) | 3 | 1/908 (0.1%) | 1 |
| BRADYCARDIA | 2/950 (0.2%) | 2 | 1/908 (0.1%) | 1 |
| CARDIAC ARREST | 7/950 (0.7%) | 7 | 11/908 (1.2%) | 11 |
| CARDIAC ASTHMA | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| CARDIAC FAILURE | 7/950 (0.7%) | 7 | 7/908 (0.8%) | 7 |
| CARDIAC FAILURE ACUTE | 0/950 (0%) | 0 | 2/908 (0.2%) | 2 |
| CARDIAC TAMPONADE | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| CARDIOGENIC SHOCK | 16/950 (1.7%) | 16 | 17/908 (1.9%) | 17 |
| CARDIOPULMONARY FAILURE | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| CONGESTIVE CARDIOMYOPATHY | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| CORONARY ARTERY OCCLUSION | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| DRESSLER'S SYNDROME | 1/950 (0.1%) | 1 | 2/908 (0.2%) | 2 |
| INTERVENTRICULAR SEPTUM RUPTURE | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| INTRACARDIAC THROMBUS | 4/950 (0.4%) | 4 | 2/908 (0.2%) | 2 |
| LEFT VENTRICULAR DYSFUNCTION | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| LEFT VENTRICULAR FAILURE | 0/950 (0%) | 0 | 2/908 (0.2%) | 2 |
| MYOCARDIAL RUPTURE | 1/950 (0.1%) | 1 | 1/908 (0.1%) | 1 |
| PALPITATIONS | 2/950 (0.2%) | 2 | 0/908 (0%) | 0 |
| PERICARDIAL EFFUSION | 4/950 (0.4%) | 4 | 0/908 (0%) | 0 |
| PERICARDITIS | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| TORSADE DE POINTES | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| VENTRICLE RUPTURE | 1/950 (0.1%) | 1 | 1/908 (0.1%) | 1 |
| VENTRICULAR EXTRASYSTOLES | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| VENTRICULAR FIBRILLATION | 30/950 (3.2%) | 30 | 23/908 (2.5%) | 23 |
| VENTRICULAR SEPTAL DEFECT ACQUIRED | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| VENTRICULAR TACHYCARDIA | 7/950 (0.7%) | 7 | 6/908 (0.7%) | 6 |
| Congenital, familial and genetic disorders | ||||
| VENTRICULAR SEPTAL DEFECT | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| Ear and labyrinth disorders | ||||
| VERTIGO | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| Gastrointestinal disorders | ||||
| ABDOMINAL PAIN UPPER | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| COLITIS | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| COLITIS ISCHAEMIC | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| DIARRHOEA | 1/950 (0.1%) | 1 | 1/908 (0.1%) | 1 |
| GASTRIC ULCER | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| GASTRIC ULCER HAEMORRHAGE | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| GASTRITIS | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| GASTROINTESTINAL HAEMORRHAGE | 0/950 (0%) | 0 | 2/908 (0.2%) | 2 |
| GASTROINTESTINAL TELANGIECTASIA | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| HAEMATEMESIS | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| HAEMATOCHEZIA | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| INTESTINAL ISCHAEMIA | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| MELAENA | 1/950 (0.1%) | 1 | 1/908 (0.1%) | 1 |
| RECTAL HAEMORRHAGE | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| RETROPERITONEAL HAEMATOMA | 0/950 (0%) | 0 | 2/908 (0.2%) | 2 |
| General disorders | ||||
| ASTHENIA | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| CARDIAC DEATH | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| CHEST PAIN | 4/950 (0.4%) | 4 | 1/908 (0.1%) | 1 |
| DEVICE MALFUNCTION | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| MULTI-ORGAN FAILURE | 1/950 (0.1%) | 1 | 2/908 (0.2%) | 2 |
| NON-CARDIAC CHEST PAIN | 5/950 (0.5%) | 5 | 4/908 (0.4%) | 4 |
| SUDDEN CARDIAC DEATH | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| SUDDEN DEATH | 1/950 (0.1%) | 1 | 2/908 (0.2%) | 2 |
| THROMBOSIS IN DEVICE | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| VESSEL PUNCTURE SITE HAEMATOMA | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| Hepatobiliary disorders | ||||
| BILIARY COLIC | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| CHOLECYSTITIS | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| CHOLECYSTITIS ACUTE | 1/950 (0.1%) | 1 | 2/908 (0.2%) | 2 |
| Infections and infestations | ||||
| BILIARY SEPSIS | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| BRONCHITIS | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| GASTROENTERITIS VIRAL | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| GROIN INFECTION | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| LUNG INFECTION | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| PNEUMONIA | 1/950 (0.1%) | 1 | 2/908 (0.2%) | 2 |
| RELAPSING FEVER | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| SEPSIS | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| SEPTIC SHOCK | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| SKIN INFECTION | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| URINARY TRACT INFECTION | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| UROSEPSIS | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| Injury, poisoning and procedural complications | ||||
| FEMORAL NECK FRACTURE | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| POST PROCEDURAL HAEMATOMA | 1/950 (0.1%) | 1 | 1/908 (0.1%) | 1 |
| POST PROCEDURAL HAEMORRHAGE | 2/950 (0.2%) | 2 | 1/908 (0.1%) | 1 |
| PROCEDURAL HAEMORRHAGE | 0/950 (0%) | 0 | 3/908 (0.3%) | 3 |
| SUBDURAL HAEMATOMA | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| TRAUMATIC HAEMATOMA | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| UPPER LIMB FRACTURE | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| VASCULAR PSEUDOANEURYSM | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| Investigations | ||||
| HAEMOGLOBIN DECREASED | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| HEPATIC ENZYME INCREASED | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| NUTRITIONAL CONDITION ABNORMAL | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| PLATELET COUNT DECREASED | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| TROPONIN INCREASED | 0/950 (0%) | 0 | 2/908 (0.2%) | 2 |
| Metabolism and nutrition disorders | ||||
| DEHYDRATION | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| DIABETES MELLITUS | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| MUSCULOSKELETAL CHEST PAIN | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| PAIN IN EXTREMITY | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| PAIN IN JAW | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| PATHOLOGICAL FRACTURE | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| ADRENAL ADENOMA | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| BLADDER NEOPLASM | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| CARDIAC MYXOMA | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE) | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| RECTAL NEOPLASM | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| RENAL CANCER METASTATIC | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| Nervous system disorders | ||||
| CEREBRAL HAEMORRHAGE | 2/950 (0.2%) | 2 | 0/908 (0%) | 0 |
| CEREBROVASCULAR ACCIDENT | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| DIZZINESS | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| DYSARTHRIA | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| HAEMORRHAGE INTRACRANIAL | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| HEMIPARESIS | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| LACUNAR INFARCTION | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| PRESYNCOPE | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| SYNCOPE | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| TRANSIENT ISCHAEMIC ATTACK | 3/950 (0.3%) | 3 | 1/908 (0.1%) | 1 |
| Psychiatric disorders | ||||
| ANXIETY | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| CONFUSIONAL STATE | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| SUICIDE ATTEMPT | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| Renal and urinary disorders | ||||
| HAEMATURIA | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| RENAL COLIC | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| RENAL FAILURE | 2/950 (0.2%) | 2 | 2/908 (0.2%) | 2 |
| RENAL FAILURE ACUTE | 0/950 (0%) | 0 | 2/908 (0.2%) | 2 |
| Respiratory, thoracic and mediastinal disorders | ||||
| ACUTE PULMONARY OEDEMA | 3/950 (0.3%) | 3 | 3/908 (0.3%) | 3 |
| ACUTE RESPIRATORY DISTRESS SYNDROME | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| ATELECTASIS | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| DIAPHRAGMATIC PARALYSIS | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| DYSPNOEA | 1/950 (0.1%) | 1 | 2/908 (0.2%) | 2 |
| HAEMOTHORAX | 2/950 (0.2%) | 2 | 0/908 (0%) | 0 |
| LUNG DISORDER | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| PLEURAL EFFUSION | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| PULMONARY EMBOLISM | 1/950 (0.1%) | 1 | 1/908 (0.1%) | 1 |
| PULMONARY OEDEMA | 1/950 (0.1%) | 1 | 4/908 (0.4%) | 4 |
| RESPIRATORY DISTRESS | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| RESPIRATORY FAILURE | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| RASH PRURITIC | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| Vascular disorders | ||||
| AORTIC DISSECTION | 1/950 (0.1%) | 1 | 2/908 (0.2%) | 2 |
| ARTERY DISSECTION | 2/950 (0.2%) | 2 | 0/908 (0%) | 0 |
| HAEMATOMA | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| HAEMODYNAMIC INSTABILITY | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| HYPERTENSION | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
| HYPOTENSION | 1/950 (0.1%) | 1 | 1/908 (0.1%) | 1 |
| ORTHOSTATIC HYPOTENSION | 1/950 (0.1%) | 1 | 0/908 (0%) | 0 |
| THROMBOPHLEBITIS | 0/950 (0%) | 0 | 1/908 (0.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Ticagrelor In-Hosp | Ticagrelor Pre-Hosp | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 529/950 (55.7%) | 469/908 (51.7%) | ||
| Cardiac disorders | ||||
| Ventricular tachycardia | 81/950 (8.5%) | 79/908 (8.7%) | ||
| Atrial fibrillation | 38/950 (4%) | 30/908 (3.3%) | ||
| Ventricular fibrillation | 37/950 (3.9%) | 32/908 (3.5%) | ||
| Cardiac failure | 33/950 (3.5%) | 30/908 (3.3%) | ||
| Bradycardia | 26/950 (2.7%) | 28/908 (3.1%) | ||
| Gastrointestinal disorders | ||||
| Dyspnoea | 86/950 (9.1%) | 62/908 (6.8%) | ||
| Nausea | 49/950 (5.2%) | 41/908 (4.5%) | ||
| Vomiting | 40/950 (4.2%) | 34/908 (3.7%) | ||
| General disorders | ||||
| Non cardiac chest pain | 52/950 (5.5%) | 42/908 (4.6%) | ||
| Metabolism and nutrition disorders | ||||
| Hypokalaemia | 26/950 (2.7%) | 28/908 (3.1%) | ||
| Nervous system disorders | ||||
| Headache | 31/950 (3.3%) | 19/908 (2.1%) | ||
| Vascular disorders | ||||
| Hypotension | 30/950 (3.2%) | 44/908 (4.8%) | ||
Limitations/Caveats
This urgent setting study included 8.6% of patients with symptoms of MI in ambulance but having finally not a STEMI diagnosis in cathlab.
No prespecified hypothesis and procedure for adjustment was made on secondary endpoints.
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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Dr Tomas Andersson MD |
|---|---|
| Organization | AstraZeneca |
| Phone | 00 46 31 77 61966 |
| tomas.lg.andersson@astrazeneca.com |
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01347580
Other Study ID Numbers:
- D5130L00006
First Posted:
May 4, 2011
Last Update Posted:
Jul 22, 2015
Last Verified:
Jul 1, 2015