Optimal Anti-Thrombotic Management Following Percutaneous Left Atrial Appendage Occlusion

Part of paid clinical trials in Austin, Texas.

Sponsor
Texas Cardiac Arrhythmia Research Foundation
Study ID
NCT07840365
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Atrial Fibrillation (AF)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Half-Dose of novel OAC — DRUG
    Patients randomized to long-term half-dose apixaban (Group hdNOAC) will receive half-dose (2.5mg BID) apixaban monotherapy throughout the study period
  • Low-dose ASA — DRUG
    In the low-dose ASA group, patients will receive full-dose of apixaban for 45 days followed by the low-dose aspirin

Study Details

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.

Key Dates

First listed
Sep 25, 2026
Start date
Sep 1, 2026
Status verified
Sep 2026
Primary completion
Dec 15, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
234 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: long-term half-dose apixaban (Group hdNOAC)
  • Active Comparator: long-term aspirin (Group ASA)

Primary Outcome Measure

Composite endpoint of DRT, TE and major bleeding events [ Time Frame: 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Cardiac Arrhythmia Institute, St. David's Medical CenterAustinTexas78705
Mitra Mohanty, MD
[email protected]
5125448198
Bryan MacDonald, MD
[email protected]
Andrea Natale (PRINCIPAL_INVESTIGATOR)

Find similar trials in Austin, TX

By research site
Texas Cardiac Arrhythmia Institute, St. David's Medical Center· Austin, TX

Related Studies