COMPARE: Prasugrel vs. Ticagrelor on Myocardial Injury in STEMI

Sponsor

AORTICA Group (Other)

Overall Status

Completed

CT.gov ID

NCT03435133

Collaborator

(none)

Enrollment

Location

Arms

37.3

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators propose to perform a randomized clinical trial comparing prasugrel vs. ticagrelor in 60 patients with ST elevation acute myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention. The principal objective of the study would be analyzing the difference in myocardial infarction size measured by cardiac magnetic resonance at 6 months

Condition or Disease	Intervention/Treatment	Phase
ST Elevation Myocardial Infarction	Drug: Prasugrel Drug: Ticagrelor	N/A

Detailed Description

Dual antiplatelet therapy consisting of aspirin and one of the P2Y12 receptor inhibitors is the mainstay of treatment for patients with ST elevation acute myocardial infarction undergoing primary percutaneous coronary intervention. Prasugrel or ticagrelor have actually shown to be superior to clopidogrel improving the prognosis of these patients. However, the industrial interest has avoided any direct comparison between these two antiplatelets. Comparison is of great interest considering that only ticagrelor has shown to significantly reduce mortality. As ticagrelor may exert off-target effects through adenosine-related mechanisms, the investigators aimed to investigate whether ticagrelor reduces myocardial injury to a greater extent than prasugrel in patients with revascularized STEMI.

Patients with acute STEMI undergoing primary percutaneous coronary revascularization within 6 hours of chest pain, will be randomized to (1) prasugrel (a 60 mg oral loading and a 10-mg dailiy maintenance dose) or to (2) ticagrelor (a 180 mg loading dose and a 90 mg twice daily maintenance dose). The predefined primary end point is infarct sieze on magnetic resonance imaging at the end of the study (6 months). Magnetic resonance will be performed at day 1, day 7 and moth 6. Platelet reactivity, biomarkers and clinical outcomes will also be assesed.

Study Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of Prasugrel vs. Ticagrelor on Myocardial Injury in Revascularized ST Elevation Acute Myocardial Infarction Patients

Actual Study Start Date :

Nov 23, 2015

Actual Primary Completion Date :

Oct 30, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Prasugrel	Drug: Prasugrel 60 mg oral bolus plus oral 10 mg once daily
Active Comparator: Ticagrelor	Drug: Ticagrelor 180 mg oral bolus plus oral 90 mg every 12 hours daily

Arm

Intervention/Treatment

Active Comparator: Prasugrel

Drug: Prasugrel

60 mg oral bolus plus oral 10 mg once daily

Active Comparator: Ticagrelor

Drug: Ticagrelor

180 mg oral bolus plus oral 90 mg every 12 hours daily

Outcome Measures

Primary Outcome Measures

Infarct size [6 months]
Cardiac magnetic resonance imaging-assessed infarct size of left ventricular mass (%)

Secondary Outcome Measures

Infarct size [up to two weeks]
Cardiac magnetic resonance imaging-assessed infarct size of left ventricular mass (%)
Myocardial salvage index [up to two weeks]
Cardiac magnetic resonance imaging-assessed myocardial salvage index
Microvascular obstruction [up to two weeks]
Cardiac magnetic resonance imaging-assessed microvascular obstruction
MACE [6 months]
The rate of MACE defined as the composite of death, reinfarction, new-onset heart failure, or rehospitalization

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age 18 years or older and equal or less than 75 years
symptom onset within 12 hours before random assignment
chest pain lasting more than 30 minutes
ST-segment elevation of at least 0.1 mV in at least 2 limb leads, ST-segment elevation of at least 0.2 mV in 2 or more contiguous precordial leads, or left bundle-branch block or paced rhythm
time from symptoms onset to randomization less than 6 hours
no severe heart failure (Killip class <3)
informed, written consent

Exclusion Criteria:

history of myocardial infarction with Q wave
history of surgical or percutaneous coronary revascularization
cardiogenic shock, defined as a systolic blood pressure <90 mm Hg with no response to fluid administration or <100 mm Hg in patients with supportive treatment and no bradycardia
history of stroke
history of bronchial asthma
symtomatic sinusal bradicardia or advance AV block
history of hypersensitivity to aspirin, prasugrel or ticagrelor or contraindication to the doses established in the study
patients pretreated with 600 mg of clopidogrel or more
contraindication for the use of gadolinium during the magenitc resonance