NCT07125417招募中4 期
Non-Antithrombotic Versus. Single antiPlatelet Therapy Following Left Atrial Appendage Closure：NAPT-LAAC Randomized Controlled Trial
OCEAN-SHD Study Group21 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年5月29日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 21
- 主要终点
- A composite endpoint consisting of all-cause mortality, myocardial infarction, stroke, systemic embolism, major bleeding, or clinically relevant non-fatal bleeding
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients who are currently enrolled in other clinical trials, except when the patient is participating in a mandatory governmental registries or purely observational registries with no associated treatment.
- •Individuals require long-term anticoagulation therapy for reasons other than atrial fibrillation (AF)-related stroke risk reduction (e.g.,thrombophilic conditions, previous pulmonary embolism, or deep venous thrombosis).
- •Patients requiring oral antiplatelet therapy for reasons other than LAAC (e.g.,history of myocardial infarction, history of endovascular treatment, history of stroke/transient ischemic attack, significant coronary stenosis proven by myocardial ischemia, severe carotid stenosis requiring invasive treatment,hematologic disease such as antiphospholipid syndrome or if the investigator and/or subinvestigator judged the need for antiplatelet therapy).
- •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
- •Those who have or are scheduled to undergo cardiac or noncardiac intervention or surgery 45 days or 60 days before or after LAAC (e.g.,cardioversion, PCI, cardiac ablation, cataract surgery, other structural heart interventions).
- •Patients with stroke (either ischemic or hemorrhagic) or transient ischemic attack within 30 days prior to enrollment
- •Patients with active bleeding
- •Individuals who lack LAA or whose LAA has been surgically ligated
- •Individuals who experienced a myocardial infarction (with or without intervention) recorded as a non-ST elevation myocardial infarction or ST elevation myocardial infarction in the 30-day period prior to enrollment
- •Patients with previous atrial septal repair or with atrial septal defect/patent foramen ovale device
- •Patients with mechanical valve prostheses at any site
- •Persons with known contraindications to TEE
- •Patients with active infection
- •Individuals with NYHA class related IV congestive heart failure at enrollment
- •Patients who are pregnant, breastfeeding, or wishing to become pregnant
- •Patients with an expected life expectancy of less than 2 years
- •Patients requiring emergency surgery for any reason
- •Patients who, at the discretion of the investigator, have other medical, social, or psychological conditions that preclude adherence to appropriate consent or the follow-up tests required by the protocol
- •Other patients whose investigator or subinvestigator judges their participation in the study to be inappropriate
研究组 & 干预措施
SAPT Arm (Single Antiplatelet Therapy Arm)
Active Comparator
干预措施: Single Antiplatelet Therapy or No Therapy (Control) (Drug)
NAPT Arm (Non-Antithrombotic Therapy Arm)
Experimental
干预措施: Non-Antithrombotic Therapy (Other)
结局指标
主要结局
A composite endpoint consisting of all-cause mortality, myocardial infarction, stroke, systemic embolism, major bleeding, or clinically relevant non-fatal bleeding
时间窗: 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.
次要结局
- Non-procedure-related BARC bleeding events of Type 1 or greater(Through study completion, maximum of four years, with a minimum follow-up period of two years from the time of randomization.)
- ISTH major bleeding not related to the procedure and 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.)
- Incidence of device-related thrombus (DRT) detected by CT and/or transesophageal echocardiography (TEE)(at Visit 1 (46~60days after randomization), 1 year, and 2 years after randomization)
- Combined endpoint consisting of the occurrence of ischemic stroke and systemic embolism(Through study completion, maximum of four years, with a minimum follow-up period of two years from the time of randomization.)
研究者
研究点 (21)
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