Assessment of Dual Antiplatelet Therapy Versus Rivaroxaban In Atrial Fibrillation Patients Treated With Left Atrial Appendage Closure "ADRIFT"


Phase 2/3 Results N/A

Eligibility Criteria

Inclusion Criteria

- Men and women ≥18 years of age
- Patients who underwent a clinically successful LAAC procedure (device implanted without procedural or bleeding complication). LAAC may have been indicated for patients contraindicated or unsuitable for long-term Vitamin K antagonists (VKA) anticoagulation.
- AF (permanent or persistent or paroxysmal) patients irrespective of prior antithrombotic treatment are eligible for randomization.
- Written informed consent by the patient or designee if the patient is unable to consent
- Patients affiliated to the French social security system

Exclusion Criteria

- Creatinine clearance <30 mL / min (Cockcroft formula).
- Dialysis.
- Mechanical heart valves or valvular disease requiring surgery or interventional procedure
- Planned Ablation of AF during follow up period
- Mandatory indication for dual antiplatelet therapy (e.g. recent stent) or single anti-platelet treatment (SAPT) (e.g. high coronary risk).
- Any contra-indication or known allergy to aspirin or clopidogrel or rivaroxaban.
- Any mandatory indication for anticoagulation for a reason other than AF (e.g. Pulmonary embolism)
- Ongoing major bleeding or complicated or recent (<72hours) major surgery
- Known large oesophageal varices or decompensated liver disease (unless a documented positive opinion of a gastro-enterologist)
- Severe thrombocytopenia (<50,000/ml) after referral to haematologist to confirm or not contraindication
- Recent myocardial infarction (<6 weeks).
- Recent cerebro-vascular event (CVE) or transient ischemic attack (<6 weeks) after evaluation of stroke vs bleeding risk by the referring neurologist.
- Recent Intracranial bleeding (< 6 months): these patients will be evaluated by a neurologist as these patients may be considered at higher stroke risk. Neurologist may consider that the LAAC procedure with a short (90 days) period of anticoagulation or antiplatelet therapy as tested in the protocol is a preferable option (in that case intracranial hemorrhage (ICH) will not be considered as a contraindication).
- Prasugrel or ticagrelor concomitant use
- Participating in an investigational drug or another device trial within the previous 30 days.
- High likelihood of being unavailable for follow-up or psycho-social condition making study participation impractical.
- Woman with child bearing potential who do not use an efficient method of contraception.
- positive serum or urine pregnancy test for woman with child bearing potential
- Pregnancy or within 48 hours post-partum or breast feeding women
- Patient under legal protection