Left ventricular (LV) thrombus after acute myocardial infarction (AMI)
Conditions
Interventions
Trade Name: XARELTO 2,5 mg
Product Name: Rivaroxaban 2,5 mg
Pharmaceutical Form: Coated tablet
INN or Proposed INN: RIVAROXABAN
CAS Number: 366789-02-8
Concentration unit: mg milligram(s)
Concentratio
Sponsors
AP-HP/DRCI
Eligibility
Sex/Gender
All
Inclusion 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. 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
Exclusion criteria: - Patients with cardiogenic shock (systolic blood pressure 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end points : - LV thrombus dimension (greatest diameter), - Rate of bleeding events using the Thrombolysis in Myocardial Infarction (TIMI) and the Bleeding Academic Research Consortium (BARC) criteria at 1 month (investigator-reported), - Rate of major adverse cardiac events (MACE) defined as a composite of death, non-fatal MI or stroke at 1 month and at 1-year*, - Rate of individual components of the MACE at 1 month and at 1-year*, - Survival without MACE and individual component of MACE at 1 month and 1 year. - Rate of occurrence of systemic thrombo-embolic event, - Rate of coronary revascularization at 1 month and at 1-year*, - Rate of stent thrombosis at 1 month and at 1-year*, - Rehospitalization for acute heart failure at 1 month and at 1-year*, - Rehospitalization in a cardiology department at 1 month and at 1-year*, - Antithrombotic drugs used in the patients with confirmed LV thrombus on CMR at one month, between 1 month and 1 year. ;Timepoint(s) of evaluation of this end point: 1 month | — |
Countries
France
Contacts
Public ContactGUIMFACK AURELIE
DRCI
Outcome results
None listed