direct oral anticoagulants for prevention of left ventricular thrombus after anterior acute myocardial infarction - aperitif

Conditions: Myocardial Infarction, Acute; Left Ventricular Thrombus

Summary: 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.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * anterior stemi (e.g., st elevation above the j-point of ≥0.1 millivolt in ≥two contiguous leads or left bundle branch block) or very high-risk nstemi (e.g., dynamic ecg changes or ongoing chest pain or acute heart failure or hemodynamic instability independent of ecg changes or life-threatening ventricular arrhythmias) with echographic evidence of anterior wall motion abnormalities and, with a culprit lesion of the proximal or mid portion of the left anterior descending (lad) on the coronary angiography; * no contraindication to cmr (e.g., claustrophobia, pacemaker or defibrillator not compatible); * ability to provide written informed consent and willing to participate in 1-month follow-up period. * affiliation of social security regime. exclusion criteria: * patients with cardiogenic shock (systolic blood pressure \<90 mmhg with clinical signs of low output or patients requiring inotropic agents); * patients referred to surgery for coronary artery bypass grafting (cabg) or treatment of acute complications (e.g. ventricular septal rupture); * patients treated with fibrinolytic therapy; * lv thrombus diagnosed before randomization using a transthoracic echocardiography; * active major bleeding or major surgery within the last 30 days;high bleeding risk (patients considered at increased risk of bleeding during dapt; e.g. precise-dapt score \>25; severe liver failure or child pugh class c); * known history of intracranial hemorrhagic stroke or intra-cranial aneurysm; * known history of peptic ulcer; * known stroke (any type) within the last 30 days; * known intolerance to aspirin, p2y12 inhibitors, rivaroxaban and their excipients; * patients with presence of malignant neoplasms at high risk of bleeding * patients with hepatic impairment * according to the smpc any contraindication to rivaroxaban, aspirin, clopidogrel, ticagrelor * known intolerance to gadolinium chelates; * chronic kidney disease (creatinine clearance (clcr) \<30 ml/min); * indication for anticoagulation (e.g. atrial fibrillation, mechanical valves, lv thrombus...); * life expectancy \<1 month; * known pregnancy at time of randomization (pregnancy test done) or breastfeeding women; * currently participating in another trial * protected adults (including individual under guardianship by court order) * persons deprived of their liberty by judicial or administrative decision

Keywords: myocardial infarction left ventricular thrombus