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Optimal Anti-Thrombotic Management Following Percutaneous Left Atrial Appendage Occlusion

RecruitingPhase 3

Optimal Anti-Thrombotic Management Following Percutaneous Left Atrial Appendage Occlusion (INTEGRAL)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Texas Cardiac Arrhythmia Research Foundation · Participants: 234 · Started: Sep 1, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07840365

Locations in the U.S.

TexasTexas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.