RecruitingPhase 4NCT07125417

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

Non-Antithrombotic Versus. Single antiPlatelet Therapy Following Left Atrial Appendage Closure:NAPT-LAAC Randomized Controlled Trial


Sponsor

OCEAN-SHD Study Group

Enrollment

500 participants

Start Date

May 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches to blood-thinning therapy after left atrial appendage closure (LAAC) — a procedure that reduces stroke risk in people with atrial fibrillation who can't safely take blood thinners long-term: one group will take a single antiplatelet drug (like aspirin), and the other will take no antithrombotic medications at all. **You may be eligible if...** - You have non-valvular atrial fibrillation (AFib not caused by a mechanical heart valve or severe mitral stenosis) - Your stroke risk score (CHA2DS2-VA) is 2 or higher - You are at increased risk for bleeding and have undergone — or are suitable for — left atrial appendage closure **You may NOT be eligible if...** - You have valvular AFib (e.g., due to severe mitral stenosis or a mechanical heart valve) - You have a strong indication for ongoing blood thinners that cannot be stopped - You have had a recent stroke or other major cardiovascular event Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSingle Antiplatelet Therapy or No Therapy (Control)

Monotherapy with oral anticoagulants (OAC) including direct oral anticoagulants (DOAC) and vitamin K antagonist oral anticoagulants (VKA) for 45 days after left atrial appendage closure (LAAC), followed by aspirin-directed antiplatelet monotherapy (Single Antiplatelet Therapy: SAPT) through the end of the observational period.

OTHERNon-Antithrombotic Therapy

Monotherapy with OAC for 45 days after LAAC, followed by no antithrombotic therapy (Non-Antithrombotic Therapy: NAPT) from enrollment through the end of the observational period.


Locations(21)

Nagoya Heart Center

Nagoya, Aichi-ken, Japan

Toyohashi Heart Center

Toyohashi, Aichi-ken, Japan

New Tokyo Hospital

Matsudo, Chiba, Japan

Kokura Kinen Hospital

Kitakyushu, Fukuoka, Japan

Gifu Heart Center

Gifu, Gifu, Japan

Medical Corporation Sapporo Heart Center Sapporo Cardio Vascular Clinic

Sapporo, Hokkaido, Japan

Sapporo Higashi Tokushukai Hospital

Sapporo, Hokkaido, Japan

Tokai University Hospital

Isehara, Kanagawa, Japan

St.Marianna University Hospital

Kawasaki, Kanagawa, Japan

Sendai Kousei Hospital

Sendai, Miyagi, Japan

Kurashiki Central Hospital

Kurashiki, Okayama-ken, Japan

The Sakakibara Heart Institute of Okayama

Okayama, Okayama-ken, Japan

Kindai University Hospital

Ōsaka-sayama, Osaka, Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

Mitsui Memorial Hospital

Chiyoda-ku, Tokyo, Japan

Sakakibara Heart Institute

Fuchū, Tokyo, Japan

Teikyo University Hospital

Itabashi-ku, Tokyo, Japan

IMS Tokyo Katsushika General Hospital

Katsushika-ku, Tokyo, Japan

Toho University Omori Medical Center

Ōta-ku, Tokyo, Japan

Keio University Hospital

Shinjuku-ku, Tokyo, Japan

Toyama University Hospital

Toyama, Toyama, Japan

View Full Details on ClinicalTrials.gov

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NCT07125417


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