Long-term half-dose apixaban versus aspirin after Watchman implantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 randomized study compares two antithrombotic strategies after successful Watchman left atrial appendage occlusion in AF patients. Participants are assigned 1:1 to either half-dose apixaban monotherapy or full-dose apixaban for 45 days followed by aspirin monotherapy, with follow-up visits and transesophageal echocardiography to monitor device function and thrombus formation. The primary endpoint is a composite of device-related thrombosis, stroke/TIA, and major bleeding. Analyses include intention-to-treat, with planned post-hoc secondary analyses. Enrollment is conducted at the Texas Cardiovascular centers with a lead sponsor and no stated collaborators.

Why it matters

Who can join: the full rules

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.

Where it's running

• Texas Cardiac Arrhythmia Institute, St. David's Medical Center
  Austin, Texas, United States Recruiting

Study contacts

• Principal investigator: Andrea Natale, MD — Texas Cardiac Arrhythmia Institute, St. David's Medical Center
• Study coordinator: Sanghamitra Mohanty, MD MS
• Email: mitra.mohanty@stdavids.com
• Phone: 5125448198

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.