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

Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Patient has documented non-valvular atrial fibrillation (i.e, atrial fibrillation without severe mitral stenosis or mechanical valves)

• Patient has CHA2DS2-VA score of 2 or greater

• Patient meets the guidelines for proper use of the left atrial appendage closure system including patient who has an increased risk of bleeding.

• Individual with nonvalvular atrial fibrillation who underwent successful LAAC (defined as no significant residual circumferential leak \[\>3 mm\] or major morbidity by the time of procedure completion).

• Patient suitable for pharmacotherapy as defined in this study protocol in both NAPT and SAPT arms

• LAA anatomy is accommodate Boston Scientific WATCHMAN FLX Pro and LAAC procedure

• The patient and the investigator and/or subinvestigator agree that the patient will return for all required VISITs after LAAC procedure

• Patient has thoroughly understood the purpose of the study and has provided written informed consent to participate in the study

Locations
Other Locations
Japan
Juntendo University Hospital
RECRUITING
Bunkyo-ku
Mitsui Memorial Hospital
RECRUITING
Chiyoda-ku
Sakakibara Heart Institute
RECRUITING
Fuchū
Gifu Heart Center
RECRUITING
Gifu
Tokai University Hospital
RECRUITING
Isehara
Teikyo University Hospital
RECRUITING
Itabashi-ku
IMS Tokyo Katsushika General Hospital
NOT_YET_RECRUITING
Katsushika-ku
St.Marianna University Hospital
RECRUITING
Kawasaki
Kokura Kinen Hospital
RECRUITING
Kitakyushu
Kurashiki Central Hospital
RECRUITING
Kurashiki
New Tokyo Hospital
RECRUITING
Matsudo
Nagoya Heart Center
RECRUITING
Nagoya
The Sakakibara Heart Institute of Okayama
RECRUITING
Okayama
Kindai University Hospital
RECRUITING
Ōsaka-sayama
Toho University Omori Medical Center
RECRUITING
Ōta-ku
Medical Corporation Sapporo Heart Center Sapporo Cardio Vascular Clinic
RECRUITING
Sapporo
Sapporo Higashi Tokushukai Hospital
RECRUITING
Sapporo
Sendai Kousei Hospital
RECRUITING
Sendai
Keio University Hospital
RECRUITING
Shinjuku-ku
Toyama University Hospital
RECRUITING
Toyama
Toyohashi Heart Center
RECRUITING
Toyohashi
Contact Information
Primary
EPS Corporation
prj-laac-napt@eps.co.jp
+81-6-7176-5731
Time Frame
Start Date: 2025-05-29
Estimated Completion Date: 2030-03-31
Participants
Target number of participants: 500
Treatments
Active_comparator: SAPT Arm (Single Antiplatelet Therapy Arm)
Experimental: NAPT Arm (Non-Antithrombotic Therapy Arm)
Related Therapeutic Areas
Sponsors
Collaborators: Boston Scientific Corporation
Leads: OCEAN-SHD Study Group

This content was sourced from clinicaltrials.gov

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