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

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Myocardial Infarction, Acute; Left Ventricular Thrombus

Treatments: Drug: Rivaroxaban 2.5 MG [Xarelto]; Drug: DAPT strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT05077683

2021-001534-19 (EudraCT Number)

APHP200015

Details and patient eligibility

About

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.

Enrollment: 560 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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560 participants in 2 patient groups

DAPT

Active Comparator group

Description:

aspirin (≤100mg per day) and P2Y12 inhibitors (i.e. clopidogrel 75mg per day or ticagrelor 90mg twice a day), as per current guidelines

Treatment:

Drug: DAPT strategy

DAPT + Direct Oral AntiCoagulants (DOAC)

Experimental group

Description:

aspirin (≤100mg per day), clopidogrel (75mg per day) or ticagrelor (90mg twice daily) and rivaroxaban 2.5mg twice daily.

Treatment:

Drug: DAPT strategy

Drug: Rivaroxaban 2.5 MG [Xarelto]