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Optimal Anti-Thrombotic Management Following Percutaneous Left Atrial Appendage Occlusion

RecruitingPhase 3Ages 18 Years - anyAllTexas Cardiac Arrhythmia Research Foundation
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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.
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What it tests

  • Half-Dose of novel OAC
  • Low-dose ASA
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Where

1 site
Texas Cardiac Arrhythmia Institute, St. David's Medical Center
Austin, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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