Pedro Dorado
Salamanca, 37007, Spain
NCT Number: NCT03435133
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
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Salamanca, 37007, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
60 mg oral bolus plus oral 10 mg once daily
180 mg oral bolus plus oral 90 mg every 12 hours daily
Time frame: 6 months
Cardiac magnetic resonance imaging-assessed infarct size of left ventricular mass (%)
Time frame: up to two weeks
Cardiac magnetic resonance imaging-assessed infarct size of left ventricular mass (%)
Time frame: up to two weeks
Cardiac magnetic resonance imaging-assessed myocardial salvage index
Time frame: up to two weeks
Cardiac magnetic resonance imaging-assessed microvascular obstruction
Time frame: 6 months
The rate of MACE defined as the composite of death, reinfarction, new-onset heart failure, or rehospitalization
AORTICA Group
Other
Comparison of Prasugrel vs. Ticagrelor on Myocardial Injury in Revascularized ST Elevation Acute Myocardial Infarction Patients
Acronym: COMPARE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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