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NCT07840365RecruitingPhase 3

Optimal Anti-Thrombotic Management Following Percutaneous Left Atrial Appendage Occlusion

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

Source: ClinicalTrials.gov · Last updated 5 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
234 (estimated)
First submitted
18 Sept 2026
Start date
1 Sept 2026
Primary completion date
15 Dec 2028
Lead sponsor
Texas Cardiac Arrhythmia Research Foundation
NCT number
NCT07840365

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 234
  • From 1 Sept 2026 to the primary completion date, 15 Dec 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • 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.

Who the study is looking for

  • • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Texas Cardiac Arrhythmia Institute, St. David's Medical Center
Coordinator of this site? Confirm its status
AustinUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.