Direct Oral Anticoagulants for Prevention of lEft ventRIcular Thrombus After Anterior Acute Myocardial InFarction - APERITIF

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Rivaroxaban

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