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

NCT05077683 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2024-07-10

No results posted yet for this 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.

Conditions

  • Myocardial Infarction, Acute
  • Left Ventricular Thrombus

Interventions

DRUG

Rivaroxaban 2.5 MG [Xarelto]

Experimental group: usual DAPT strategy (aspirin (≤100mg per day), clopidogrel (75mg per day) or ticagrelor (90mg twice daily)) + rivaroxaban 2.5mg twice daily.

DRUG

DAPT strategy

usual DAPT strategy (aspirin (≤100mg per day), clopidogrel (75mg per day) or ticagrelor (90mg twice daily)) +

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Etienne PUYMIRAT · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-10
Primary Completion
2023-03-10
Completion
2024-02-09

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05077683 on ClinicalTrials.gov