NCT07840365

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P25-P50 for phase_3

Timeline
37mo left

Started Sep 2026

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Sep 2026Sep 2029

Study Start

First participant enrolled

September 1, 2026

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2028

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2029

Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

2.3 years

First QC Date

September 18, 2026

Last Update Submit

September 25, 2026

Conditions

Atrial Fibrillation (AF)

Keywords

oral anticoagulationLeft atrial appendage occlusionatrial fibrillationAspirin

Outcome Measures

Primary Outcomes (1)

  • Composite endpoint of DRT, TE and major bleeding events

    Composite endpoint of device-related thrombosis, TE and major bleeding events

    3 years

Study Arms (2)

long-term half-dose apixaban (Group hdNOAC)

ACTIVE COMPARATOR
Drug: Half-Dose of novel OAC

long-term aspirin (Group ASA)

ACTIVE COMPARATOR
Drug: Low-dose ASA

Interventions

Half-Dose of novel OACDRUG

Patients randomized to long-term half-dose apixaban (Group hdNOAC) will receive half-dose (2.5mg BID) apixaban monotherapy throughout the study period

long-term half-dose apixaban (Group hdNOAC)
Low-dose ASADRUG

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.

long-term aspirin (Group ASA)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Austin, Texas, 78705, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Andrea Natale, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanghamitra Mohanty, MD MS

CONTACT

5125448198mitra.mohanty@stdavids.com

Angel Mayedo, MD

CONTACT

512-544-8198angel.mayedo@stdavids.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Medical director

Study Record Dates

First Submitted

September 18, 2026

First Posted

September 25, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

December 15, 2028

Study Completion (Estimated)

September 30, 2029

Last Updated

September 30, 2026

Record last verified: 2026-09

Locations

US(1)