EligibleTrials

Non-antithrombotic Versus. Single Antiplatelet Therapy Following Left Atrial Appendage Closure

Recruiting · NCT07125417 · Interventional (participants receive a specific treatment) · Lead sponsor: OCEAN-SHD Study Group

View the official record on ClinicalTrials.gov →
Atrial fibrillation

Interventions studied

Non-Antithrombotic TherapySingle Antiplatelet Therapy or No Therapy (Control)

What this trial is about

The goal of this clinical trial is to verify that Non-Antithrombotic Therapy (NAPT) followed by Oral Anticoagulants (OAC) monotherapy for 45 days after Left Atrial Appendage Closure (LAAC) is non-inferior to Single Antiplatelet Therapy (SAPT) with aspirin during the period from randomization to the end of observational period (4 years at the maximum) in non-valvular atrial fibrillation subjects with high bleeding risk. The primary endpoint is a composite endpoint consisting of all-cause mortality, myocardial infarction, stroke, systemic embolism, major bleeding, or clinically relevant non-fatal bleeding from randomization to the end of study observation (up to a maximum follow-up of 4 years). * Participants will be enrolled in this study until the day following the implementation of LAAC and will be randomized to the SAPT arm and NAPT arm in a 1:1 ratio. * Participants will be observed for 4 years from the time the first subject is enrolled in this study. * Participants will visit the hospital at 45 days, 1 year, and 2 years after enrollment, and will also be followed up by telephone, basically at the end of the observation period (up to a maximum follow-up of 4 years). \<Study treatment duration\> In both arms, OAC monotherapy will be initiated in the first 24 hours of enrollment and continued for 45 days (allowed window period: plus 2 weeks).. * SAPT arm will continue to receive 45 days of OAC monotherapy followed by low-dose aspirin (75~100 mg/day) as an antithrombotic agent required through the end of the study observation period. * NAPT arm do not receive antithrombotic medication after 45 days of OAC monotherapy through the end of the study observation period.

Who can take part

Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)

Inclusion criteria

Exclusion criteria

Where it is running

21 locations listed.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →

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