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

NCT ID: NCT05077683

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 560 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-10
• Study Completion Date: 2024-02-09

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DAPT

aspirin (≤100mg per day) and P2Y12 inhibitors (i.e. clopidogrel 75mg per day or ticagrelor 90mg twice a day), as per current guidelines

Group Type: ACTIVE_COMPARATOR

DAPT strategy

Intervention Type: DRUG

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

DAPT + Direct Oral AntiCoagulants (DOAC)

aspirin (≤100mg per day), clopidogrel (75mg per day) or ticagrelor (90mg twice daily) and rivaroxaban 2.5mg twice daily.

Group Type: EXPERIMENTAL

DAPT strategy

Intervention Type: DRUG

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

Rivaroxaban 2.5 MG [Xarelto]

Intervention Type: DRUG

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

Interventions

DAPT strategy

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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.

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;
• 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, LV thrombus…);
• Life expectancy <1 month;
• Known pregnancy at time of randomization (pregnancy test done) 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Etienne PUYMIRAT

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

HEGP

Paris, , France

Countries

France

References

Puymirat E, Soulat G, Fayol A, Mousseaux E, Montalescot G, Cayla G, Steg PG, Berard L, Rousseau A, Drouet E, Simon T, Danchin N; APERITIF study investigators. Rationale and design of the direct oral anticoagulants for prevention of left ventricular thrombus after anterior acute myocardial infarction (APERITIF) trial. Am Heart J. 2023 Dec;266:98-105. doi: 10.1016/j.ahj.2023.09.005. Epub 2023 Sep 14.

Reference Type: DERIVED

PMID: 37716448 (View on PubMed)

Other Identifiers

2021-001534-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

APHP200015

Identifier Type: -

Identifier Source: org_study_id