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

• Status: Completed
• Trial end date: 2019-09-30
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of 2 doses of rivaroxaban (10 and 15 mg) compared to dual anti platelet therapy (aspirin+clopidogrel) after left atrial appendage closure. The patients will be assessed at 10 and 90 days: central laboratory hemostasis analysis and clinical events assessment.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Action Research Group; Bayer
• Treatments: Rivaroxaban

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