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

Myocardial Infarction, Acute Clinical Trial

— APERITIF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05077683
• Other study ID #: APHP200015
• Secondary ID: 2021-001534-19
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 18, 2021
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 560
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Left Ventricular Thrombus
• Myocardial Infarction
• Myocardial Infarction, Acute
• Thrombosis

Intervention

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

Locations

Country	Name	City	State
France	HEGP	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of thrombus between the two arms	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).; The primary endpoint is the presence of Left Ventricular (LV) thrombus at 1-month, as detected by the validated delayed enhancement (Cardiovascular Magnetic Resonance) CMR method	1 month
Secondary	Description of the thrombus	LV thrombus dimension (greatest diameter)	1 month
Secondary	Rate of bleeding events	Rate of bleeding events using the Thrombolysis in Myocardial Infarction (TIMI) and the Bleeding Academic Research Consortium (BARC) criteria at 1 month (investigator-reported),	1 month
Secondary	Rate of major adverse cardiac events (MACE) at 1 month	Rate of major adverse cardiac events (MACE) defined as a composite of death, non-fatal MI or stroke at 1 month	1 month
Secondary	Rate of major adverse cardiac events (MACE) at 1 year	Rate of major adverse cardiac events (MACE) defined as a composite of death, non-fatal MI or stroke at 1-year	1 year
Secondary	Rate of antithrombotic using	Antithrombotic drugs used in the patients with confirmed LV thrombus on CMR between 1 month and 1 year	1 year