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RECRUITING
NCT07840365
PHASE3

Optimal Anti-Thrombotic Management Following Percutaneous Left Atrial Appendage Occlusion

Sponsor: Texas Cardiac Arrhythmia Research Foundation

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

234

Start Date

2026-09-01

Completion Date

2029-09-30

Last Updated

2026-09-30

Healthy Volunteers

No

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

Patients randomized to long-term aspirin (Group ASA) will receive full-dose (5mg BID) apixaban for 45 days followed by aspirin 81-100mg monotherapy throughout the study period.

Locations (1)

Texas Cardiac Arrhythmia Institute, St. David's Medical Center

Austin, Texas, United States