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RECRUITING
NCT07125417
PHASE4

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

Sponsor: OCEAN-SHD Study Group

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2025-05-29

Completion Date

2030-03-31

Last Updated

2025-08-15

Healthy Volunteers

No

Interventions

DRUG

Single 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.

OTHER

Non-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