💬In plain words
What the trial is, and whether it could suit you
This randomized study was designed to compare two antithrombotic regimens (long-term half-dose apixaban vs long-term aspirin after 45-days of full-dose apixaban) after successful Watchman implantation.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* • Men and women ≥18 years of age;
* Patients who underwent a clinically successful LAA closure procedure with a Watchman device (device implanted without procedural or bleeding complication) within a day or are scheduled to undergo the LAAO procedure
* Paroxysmal, persistent, or permanent AF patients irrespective of prior antithrombotic treatment are eligible for randomization,
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Exclusion Criteria:
* Two or more clinical characteristics at baseline (age≥80 years, body weight ≤60 kg, serum creatinine ≥1.5 mg/dL) requiring apixaban dosage adjustment;
* Mechanical heart valves or valvular disease requiring surgery or interventional procedure;
* 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 apixaban;
* 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;
* Recent myocardial infarction (\<6 weeks);
* Recent TE event (\<6 weeks)
* Recent Intracranial bleeding (\< 6 months);
* 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;
* Pregnancy or within 48 hours post-partum or breast feeding women;
* Patient under legal protection.