NCT05077683CompletedPhase 3
Direct Oral Anticoagulants for Prevention of lEft ventRIcular Thrombus After Anterior Acute Myocardial InFarction - APERITIF
Direct Oral Anticoagulants for Prevention of lEft ventRIcular Thrombus After Anterior Acute Myocardial InFarction
Source: ClinicalTrials.gov · Last updated 10 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 560 (actual)
- First submitted
- 27 Sept 2021
- Start date
- 10 Oct 2021
- Primary completion date
- 10 Mar 2023
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Coronary artery disease
- NCT number
- NCT05077683
- EudraCT number
- 2021-001534-19
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 560
- From 10 Oct 2021 to the primary completion date, 10 Mar 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- Known intolerance to aspirin, P2Y12 inhibitors, rivaroxaban and their excipients;
Other illness
- 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;
- Patients with presence of malignant neoplasms at high risk of bleeding
- Patients with hepatic impairment
Lab values
- Chronic kidney disease (creatinine clearance (ClCr) \<30 mL/min);
Other
- Patients with cardiogenic shock (systolic blood pressure \<90 mmHg with clinical signs of low output or patients requiring inotropic agents);
- LV thrombus diagnosed before randomization using a transthoracic echocardiography;
- According to the SmPC any contraindication to rivaroxaban, aspirin, clopidogrel, ticagrelor
- Known intolerance to gadolinium chelates;
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HEGP Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.