Non-antithrombotic Versus. Single Antiplatelet Therapy Following Left Atrial Appendage Closure
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
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.
Study 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
Primary outcome measure(s)
- A composite endpoint consisting of all-cause mortality, myocardial infarction, stroke, systemic embolism, major bleeding, or clinically relevant non-fatal bleeding — Through study completion, maximum of four years, with a minimum follow-up period of two years from the time of randomization.
The definition of major bleeding or clinically significant nonfatal bleeding for the primary endpoint is BARC type 2, 3, or 5 bleeding among BARC type 1, 2, 3, 4, and 5. Surviving cases with no events shall be censored as of the date of discontinuation of study treatment or the date of last confirmation of survival. Planned enrollment term is two years, and all subjects will be obsserved until 4 years after first enrollment.
Trial sites (21)
| Facility | City | Region | Status |
|---|---|---|---|
| Nagoya Heart Center | Nagoya | Aichi-ken | Recruiting |
| Toyohashi Heart Center | Toyohashi | Aichi-ken | Recruiting |
| New Tokyo Hospital | Matsudo | Chiba | Recruiting |
| Kokura Kinen Hospital | Kitakyushu | Fukuoka | Recruiting |
| Gifu Heart Center | Gifu | Gifu | Recruiting |
| Medical Corporation Sapporo Heart Center Sapporo Cardio Vascular Clinic | Sapporo | Hokkaido | Recruiting |
| Sapporo Higashi Tokushukai Hospital | Sapporo | Hokkaido | Recruiting |
| Tokai University Hospital | Isehara | Kanagawa | Recruiting |
| St.Marianna University Hospital | Kawasaki | Kanagawa | Recruiting |
| Sendai Kousei Hospital | Sendai | Miyagi | Recruiting |
| Kurashiki Central Hospital | Kurashiki | Okayama-ken | Recruiting |
| The Sakakibara Heart Institute of Okayama | Okayama | Okayama-ken | Recruiting |
| Kindai University Hospital | Ōsaka-sayama | Osaka | Recruiting |
| Juntendo University Hospital | Bunkyo-ku | Tokyo | Recruiting |
| Mitsui Memorial Hospital | Chiyoda-ku | Tokyo | Recruiting |
| Sakakibara Heart Institute | Fuchū | Tokyo | Recruiting |
| Teikyo University Hospital | Itabashi-ku | Tokyo | Recruiting |
| IMS Tokyo Katsushika General Hospital | Katsushika-ku | Tokyo | Not Yet Recruiting |
| Toho University Omori Medical Center | Ōta-ku | Tokyo | Recruiting |
| Keio University Hospital | Shinjuku-ku | Tokyo | Recruiting |
| Toyama University Hospital | Toyama | Toyama | Recruiting |
More OCEAN-SHD Study Group trials in Japan
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07125417 on ClinicalTrials.gov ↗ ← All trials in Japan