APERITIF is a prospective randomized open-label, blinded end-point (PROBE) trial, nested in the ongoing the "FRENCHIE" registry, a French multicenter prospective observational study granted by "ANR-RHU Grand Emprunt", in which all consecutive patients admitted within 48 hours after symptom onset in a cardiac Intensive Care Unit (ICU) for an acute myocardial infarction (AMI) are included (NCT04050956). Among them, eligible Patients for "APERITIF" will be randomized into two groups: Dual Anti-Platelet Therapy (DAPT) alone or DAPT plus rivaroxaban 2.5mg twice daily for 4 weeks, prescribed as soon as possible after admission and completion of the initial percutaneous coronary intervention/angiography procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
560
Experimental group: usual DAPT strategy (aspirin (≤100mg per day), clopidogrel (75mg per day) or ticagrelor (90mg twice daily)) + rivaroxaban 2.5mg twice daily.
usual DAPT strategy (aspirin (≤100mg per day), clopidogrel (75mg per day) or ticagrelor (90mg twice daily)) +
HEGP
Paris, France
Rate of thrombus between the two arms
The main objective of this randomized trial is to determine whether, in anterior AMI patients (e.g., large necrosis area), the use of rivaroxaban 2.5mg twice daily in addition to DAPT (dual antiplatelet therapy) will reduce LV thrombus formation, compared with the use of DAPT alone (current practice). The primary endpoint is the presence of Left Ventricular (LV) thrombus at 1-month, as detected by the validated delayed enhancement (Cardiovascular Magnetic Resonance) CMR method
Time frame: 1 month
Description of the thrombus
LV thrombus dimension (greatest diameter)
Time frame: 1 month
Rate of bleeding events
Rate of bleeding events using the Thrombolysis in Myocardial Infarction (TIMI) and the Bleeding Academic Research Consortium (BARC) criteria at 1 month (investigator-reported),
Time frame: 1 month
Rate of major adverse cardiac events (MACE) at 1 month
Rate of major adverse cardiac events (MACE) defined as a composite of death, non-fatal MI or stroke at 1 month
Time frame: 1 month
Rate of major adverse cardiac events (MACE) at 1 year
Rate of major adverse cardiac events (MACE) defined as a composite of death, non-fatal MI or stroke at 1-year
Time frame: 1 year
Rate of antithrombotic using
Antithrombotic drugs used in the patients with confirmed LV thrombus on CMR between 1 month and 1 year
Time frame: 1 year
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