NCT07840365From ClinicalTrials.govRecruiting

Optimal Anti-Thrombotic Management Following Percutaneous Left Atrial Appendage Occlusion

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

Atrial Fibrillation (AF)

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Texas Cardiac Arrhythmia Research Foundation
Enrolment target: 234
Started: 1 September 2026
Main results due: 15 December 2028
Study sites: 1
Registry updated: 25 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the 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.

What this study is about

In the sponsor’s own words, from the registry.

Optimal antithrombotic therapy after percutaneous left atrial appendage occlusion (LAAO) to prevent device-related thrombosis (DRT) is not well established. The main aim of improving the drug strategy after appendage closure is to synergistically optimize the device-based thromboembolic (TE) prevention without increasing the risk of thrombus formation on device and bleeding events. Short-term dual antiplatelet therapy (DAPT) followed by long-term aspirin monotherapy is a strategy commonly prescribed after LAA occlusion. Nonetheless, a significant number of patients continues to suffer from major bleeding and device-related thrombosis (DRT). Recent data reported that, after percutaneous LAA occlusion, a significant activation of the coagulation system occurs, without evidence of a concomitant platelet activation \[1\]. However, OAC at full dose is not only contraindicated, but also potentially detrimental in patients with an indication for LAA occlusion, given their high bleeding risk and the resulting unsuitability to long term anticoagulation. Half-dose NOAC may provide improved protection against DRT and TE events, without increasing the risk of bleeding. The recent Assessment of Dual Antiplatelet Therapy Versus Rivaroxaban in AF Patients Treated with Left Atrial Appendage Closure (ADRIFT) study \[2\] reported a better control of thrombin generation in patients with half-dose rivaroxaban compared to DAPT. Additionally, in a prospective series of 555 AF patients, Della Rocca et al have documented long-term half-dose direct oral anticoagulants (DOAC) to be associated with significant reduction in the risk of the composite endpoint of DRT, TE and major bleeding events compared with a standard antiplatelet based antithrombotic therapy (2).

On the basis of these observations, we designed a randomized study 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.

Study sites(1)

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

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07840365. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

Not the right study?

Answer three questions and see the studies recruiting near you, in plain language.

Find a study for me