Direct Oral Anticoagulants for Prevention of lEft ventRIcular Thrombus After Anterior Acute Myoca… (NCT05077683) | Clinical Trial Compass
CompletedPhase 3
Direct Oral Anticoagulants for Prevention of lEft ventRIcular Thrombus After Anterior Acute Myocardial InFarction - APERITIF
France560 participantsStarted 2021-10-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 s…