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

Last updated: August 12, 2025
Sponsor: OCEAN-SHD Study Group
Overall Status: Active - Recruiting

Phase

4

Condition

Atrial Fibrillation

Arrhythmia

Chest Pain

Treatment

Non-Antithrombotic Therapy

Single Antiplatelet Therapy or No Therapy (Control)

Clinical Study ID

NCT07125417
NAPT-LAAC trial
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Patient has documented non-valvular atrial fibrillation (i.e, atrial fibrillationwithout severe mitral stenosis or mechanical valves)

  2. Patient has CHA2DS2-VA score of 2 or greater

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

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

  5. Patient suitable for pharmacotherapy as defined in this study protocol in both NAPTand SAPT arms

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

  7. The patient and the investigator and/or subinvestigator agree that the patient willreturn for all required VISITs after LAAC procedure

  8. Patient has thoroughly understood the purpose of the study and has provided writteninformed consent to participate in the study

Exclusion

Exclusion Criteria:

  1. Patients who are currently enrolled in other clinical trials, except when thepatient is participating in a mandatory governmental registries or purelyobservational registries with no associated treatment.

  2. Individuals require long-term anticoagulation therapy for reasons other than atrialfibrillation (AF)-related stroke risk reduction (e.g.,thrombophilic conditions,previous pulmonary embolism, or deep venous thrombosis).

  3. Patients requiring oral antiplatelet therapy for reasons other than LAAC (e.g.,history of myocardial infarction, history of endovascular treatment, historyof stroke/transient ischemic attack, significant coronary stenosis proven bymyocardial ischemia, severe carotid stenosis requiring invasivetreatment,hematologic disease such as antiphospholipid syndrome or if theinvestigator and/or subinvestigator judged the need for antiplatelet therapy).

  4. Patients who meet one or more of the following criteria

  • Patients who are contraindicated for DOAC or VKA

  • Patients with a contraindication to aspirin

  • Patients diagnosed with an allergy to aspirin

  1. Those who have or are scheduled to undergo cardiac or noncardiac intervention orsurgery 45 days or 60 days before or after LAAC (e.g.,cardioversion, PCI, cardiacablation, cataract surgery, other structural heart interventions).

  2. Patients with stroke (either ischemic or hemorrhagic) or transient ischemic attackwithin 30 days prior to enrollment

  3. Patients with active bleeding

  4. Individuals who lack LAA or whose LAA has been surgically ligated

  5. Individuals who experienced a myocardial infarction (with or without intervention)recorded as a non-ST elevation myocardial infarction or ST elevation myocardialinfarction in the 30-day period prior to enrollment

  6. Patients with previous atrial septal repair or with atrial septal defect/patentforamen ovale device

  7. Patients with mechanical valve prostheses at any site

  8. Persons with known contraindications to TEE

  9. Patients with active infection

  10. Individuals with NYHA class related IV congestive heart failure at enrollment

  11. Patients who are pregnant, breastfeeding, or wishing to become pregnant

  12. Patients with an expected life expectancy of less than 2 years

  13. Patients requiring emergency surgery for any reason

  14. Patients who, at the discretion of the investigator, have other medical, social, orpsychological conditions that preclude adherence to appropriate consent or thefollow-up tests required by the protocol

  15. Other patients whose investigator or subinvestigator judges their participation inthe study to be inappropriate

Study Design

Total Participants: 500
Treatment Group(s): 2
Primary Treatment: Non-Antithrombotic Therapy
Phase: 4
Study Start date:
May 29, 2025
Estimated Completion Date:
March 31, 2030

Connect with a study center

  • Nagoya Heart Center

    Nagoya, Aichi 461-0045
    Japan

    Active - Recruiting

  • Toyohashi Heart Center

    Toyohashi, Aichi 441-8530
    Japan

    Active - Recruiting

  • New Tokyo Hospital

    Matsudo, Chiba 270-2232
    Japan

    Active - Recruiting

  • Kokura Kinen Hospital

    Kitakyushu, Fukuoka 802-8555
    Japan

    Active - Recruiting

  • Medical Corporation Sapporo Heart Center Sapporo Cardio Vascular Clinic

    Sapporo, Hokkaido 007-0849
    Japan

    Active - Recruiting

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, Hokkaido 065-0033
    Japan

    Active - Recruiting

  • Tokai University Hospital

    Isehara, Kanagawa 259-1193
    Japan

    Active - Recruiting

  • St.Marianna University Hospital

    Kawasaki, Kanagawa 216-8511
    Japan

    Active - Recruiting

  • Sendai Kousei Hospital

    Sendai, Miyagi 981-0914
    Japan

    Active - Recruiting

  • Kurashiki Central Hospital

    Kurashiki, Okayama 710-8602
    Japan

    Active - Recruiting

  • Kindai University Hospital

    Osaka sayama, Osaka 589-8511
    Japan

    Active - Recruiting

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo 113-8431
    Japan

    Active - Recruiting

  • Mitsui Memorial Hospital

    Chiyoda-ku, Tokyo 101-8643
    Japan

    Active - Recruiting

  • Sakakibara Heart Institute

    Fuchu, Tokyo 183-0003
    Japan

    Active - Recruiting

  • Teikyo University Hospital

    Itabashi-ku, Tokyo 173-8606
    Japan

    Active - Recruiting

  • IMS Tokyo Katsushika General Hospital

    Katsushika-ku, Tokyo 124-0025
    Japan

    Site Not Available

  • Toho University Omori Medical Center

    Ota-ku, Tokyo 143-8541
    Japan

    Active - Recruiting

  • Keio University Hospital

    Shinjuku-ku, Tokyo 160-8582
    Japan

    Active - Recruiting

  • Gifu Heart Center

    Gifu, 500-8384
    Japan

    Active - Recruiting

  • The Sakakibara Heart Institute of Okayama

    Okayama, 700-0804
    Japan

    Active - Recruiting

  • Toyama University Hospital

    Toyama, 930-0194
    Japan

    Active - Recruiting

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