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

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Left atrial appendage closure, Rivaroxaban, Dual antiplatelet therapy, Anticoagulation, Stroke prevention Read More

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