Direct oral Anticoagulants for Prevention of lEft ventRIcular Thrombus after anterior acute myocardial InFarctio

Phase 1

• Conditions: eft ventricular (LV) thrombus after acute myocardial infarction (AMI); Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-001534-19-FR
• Lead Sponsor: AP-HP/DRCI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-25
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 560

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

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;
-According to the SmPC any contraindication to rivaroxaban, aspirin, clopidogrel, ticagrelor, and prasugrel
-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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of this randomized trial is to determine whether, in anterior AMI patients (e.g., large necrosis area), the use of rivaroxaban 2.5mg twice daily in addition to DAPT (dual antiplatelet therapy) will reduce LV thrombus formation, compared with the use of DAPT alone (current practice).;Secondary Objective: The secondary objectives are to assess the efficacy and safety of rivaroxaban 2.5mg twice daily in addition to DAPT in the prevention clinical events compared to DAPT alone.;Primary end point(s): The primary endpoint is the presence of LV thrombus at 1-month, as detected by the validated delayed enhancement CMR (DE-CMR) method;Timepoint(s) of evaluation of this end point: 1month