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

PHASE4RecruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

May 29, 2025

Primary Completion Date

May 31, 2029

Study Completion Date

March 31, 2030

Conditions
Nonvalvular Atrial FibrillationAspirinNon-Antithrombotic TherapyHigh Bleeding RiskLeft Atrial Appendage Closure
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.

Trial Locations (21)

461-0045

RECRUITING

Nagoya Heart Center, Nagoya

441-8530

RECRUITING

Toyohashi Heart Center, Toyohashi

270-2232

RECRUITING

New Tokyo Hospital, Matsudo

802-8555

RECRUITING

Kokura Kinen Hospital, Kitakyushu

500-8384

RECRUITING

Gifu Heart Center, Gifu

007-0849

RECRUITING

Medical Corporation Sapporo Heart Center Sapporo Cardio Vascular Clinic, Sapporo

065-0033

RECRUITING

Sapporo Higashi Tokushukai Hospital, Sapporo

259-1193

RECRUITING

Tokai University Hospital, Isehara

216-8511

RECRUITING

St.Marianna University Hospital, Kawasaki

981-0914

RECRUITING

Sendai Kousei Hospital, Sendai

710-8602

RECRUITING

Kurashiki Central Hospital, Kurashiki

700-0804

RECRUITING

The Sakakibara Heart Institute of Okayama, Okayama

589-8511

RECRUITING

Kindai University Hospital, Ōsaka-sayama

113-8431

RECRUITING

Juntendo University Hospital, Bunkyo-ku

101-8643

RECRUITING

Mitsui Memorial Hospital, Chiyoda-ku

183-0003

RECRUITING

Sakakibara Heart Institute, Fuchū

173-8606

RECRUITING

Teikyo University Hospital, Itabashi-ku

124-0025

NOT_YET_RECRUITING

IMS Tokyo Katsushika General Hospital, Katsushika-ku

143-8541

RECRUITING

Toho University Omori Medical Center, Ōta-ku

160-8582

RECRUITING

Keio University Hospital, Shinjuku-ku

930-0194

RECRUITING

Toyama University Hospital, Toyama

Sponsors
All Listed Sponsors
collaborator

Boston Scientific Corporation

INDUSTRY

lead

OCEAN-SHD Study Group

OTHER