Phase
Condition
Thrombosis
Angina
Heart Disease
Treatment
Rivaroxaban 2.5 MG [Xarelto]
DAPT strategy
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years;
Anterior STEMI (e.g., ST elevation above the J-point of ≥0.1 millivolt in ≥twocontiguous 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 hemodynamicinstability independent of ECG changes or life-threatening ventricular arrhythmias)with echographic evidence of anterior wall motion abnormalities and, with a culpritlesion of the proximal or mid portion of the left anterior descending (LAD) on thecoronary angiography;
No contraindication to CMR (e.g., claustrophobia, pacemaker or defibrillator notcompatible);
Ability to provide written informed consent and willing to participate in 1-monthfollow-up period.
Affiliation of social security regime.
Exclusion
Exclusion Criteria:
Patients with cardiogenic shock (systolic blood pressure <90 mmHg with clinicalsigns of low output or patients requiring inotropic agents);
Patients referred to surgery for coronary artery bypass grafting (CABG) or treatmentof 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-DAPTscore >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, LVthrombus...);
Life expectancy <1 month;
Known pregnancy at time of randomization (pregnancy test done) or breastfeedingwomen;
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
Connect with a study center
HEGP
Paris,
FranceSite Not Available
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