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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
- Half-Dose of novel OAC (drug)
- Low-dose ASA (drug)
Sponsor: Texas Cardiac Arrhythmia Research Foundation · Participants: 234 · Started: Sep 1, 2026
Contact the study team
- Sanghamitra Mohanty, MD MS · Phone: 5125448198
- Angel Mayedo, MD · Phone: 512-544-8198
Official record on ClinicalTrials.gov — NCT07840365
Locations in the U.S.
| Texas | Texas 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.