NCT07840365 · Texas Cardiac Arrhythmia Research Foundation
Optimal Anti-Thrombotic Management Following Percutaneous Left Atrial Appendage Occlusion
(INTEGRAL)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Half-Dose of novel OAC
Patients randomized to long-term half-dose apixaban (Group hdNOAC) will receive half-dose (2.5mg BID) apixaban monotherapy throughout the study period
DRUG
Low-dose ASA
In the low-dose ASA group, patients will receive full-dose of apixaban for 45 days followed by the low-dose aspirin
Primary outcome measures
Composite endpoint of DRT, TE and major bleeding events
Time frame: 3 years
Composite endpoint of device-related thrombosis, TE and major bleeding events
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Austin, Texas
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 5, 2026 · Source of record for eligibility and locations