Clinical trial NCT05077683: Direct Oral Anticoagulants for Prevention of lEft ventRIcular Thrombus After Anterior Acute Myocardial InFarction - APERITIF
Official title: Direct Oral Anticoagulants for Prevention of lEft ventRIcular Thrombus After Anterior Acute Myocardial InFarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Infarction, Acute
Left Ventricular Thrombus
Keywords: Myocardial infarction
Left ventricular thrombus
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Rate of thrombus between the two arms
timeFrame: 1 month
Secondary outcomes:
measure: Description of the thrombus
timeFrame: 1 month
measure: Rate of bleeding events
timeFrame: 1 month
measure: Rate of major adverse cardiac events (MACE) at 1 month
timeFrame: 1 month
measure: Rate of major adverse cardiac events (MACE) at 1 year
timeFrame: 1 year
measure: Rate of antithrombotic using
timeFrame: 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: HEGP
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Etienne PUYMIRAT
role: PRINCIPAL_INVESTIGATOR
References: