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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.