Direct Oral Anticoagulants for Prevention of lEft ventRIcular Thrombus After Anterior Acute Myocardial InFarction - APERITIF

Last updated: July 8, 2024
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Completed

Phase

3

Condition

Thrombosis

Angina

Heart Disease

Treatment

Rivaroxaban 2.5 MG [Xarelto]

DAPT strategy

Clinical Study ID

NCT05077683
APHP200015
2021-001534-19
  • Ages > 18
  • All Genders

Study 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.

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

Total Participants: 560
Treatment Group(s): 2
Primary Treatment: Rivaroxaban 2.5 MG [Xarelto]
Phase: 3
Study Start date:
October 10, 2021
Estimated Completion Date:
February 09, 2024

Connect with a study center

  • HEGP

    Paris,
    France

    Site Not Available

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