Optimal Anti-Thrombotic Management Following Percutaneous Left Atrial Appendage Occlusion
Public ClinicalTrials.gov record NCT07840365. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Optimal Anti-Thrombotic Management Following Percutaneous Left Atrial Appendage Occlusion (INTEGRAL)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT07840365
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 234 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2026
- Primary completion
- Dec 14, 2028
- Completion
- Sep 29, 2029
- Last update posted
- Sep 24, 2026
2026 – 2029
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Texas Cardiac Arrhythmia Institute, St. David's Medical Center | Austin | Texas | 78705 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07840365, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 24, 2026 · Synced Sep 27, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07840365 live on ClinicalTrials.gov.