2024-516382-37-00招募中4 期
Optimal Antiplatelet Treatment to Achieve Stroke Avoidance and Fall in Bleeding Events following Left Atrial Appendage Closure (SAFE-LAAC). Comparative Health Effectiveness Randomized Trial – PILOT Study
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy10 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年12月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Primary endpoint: comprising major adverse cardiac and cerebrovascular events defined as: 1. efficacy: MACCE - stroke, TIA, peripheral embolism, nonfatal myocardial infarction, cardiovascular and overall mortality; device related thrombosis; and 2. safety: moderate and severe bleedings (type 2-5 BARC).
研究概览
简要总结
- To compare safety and efficacy of early DAPT discontinuation at 30 days postprocedure and continuation of SAPT up until 6-month vs 6 months of postprocedural DAPT (randomized comparison)
- To compare safety and efficacy of chronic SAPT beyond 6 months postprocedure vs discontinuation of all antiplatelet treatment 6 months after LAAC (nonrandomized comparison).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Successful percutaneous left atrial appendage occlusion with Amplatzer or WATCHMAN devices within 37 days prior to randomization
- •Treatment with dual antiplatelet therapy since the procedure (aspirin and clopidogrel)
- •Age >= 18 yrs
- •Participant is willing to comply with all aspects of the protocol including the assigned treatment strategy and follow-up visits
- •The participant is willing to give written informed consent
排除标准
- •Any indication to chronic antiplatelet therapy other than atrial fibrillation or left atrial appendage occlusion.
- •Indications to chronic anticoagulation
- •Known allergy to clopidogrel of acetylsalicylic acid
- •Diagnosis of coagulation disorders
- •Peridevice leaks greater than 5mm
- •Thrombus in the left atrium on the qualifying imaging of the left atrium
- •Life expectancy less than the duration of the trial due to noncardiovascular comorbidity
- •Enrollment into a competing trial using a non-approved devices or drugs - currently and up to 3 months prior to enrollment
- •Chronic kidney disease stage IV or V
- •Women who are pregnant or breastfeeding and those women of childbearing potential who do not agree to use at least two contraceptive measures (oral contraception, mechanical contraception, approved contraceptive implants, intrauterine device, tubal ligation). The criterion does not apply to women who have been postmenopausal for at least 2 years prior to study enrollment (defined as at least one year without menstrual periods) or underwent surgical sterilization procedure. All eligible women who are younger than 55 years must have negative pregnancy test within 24 hours prior to randomization.
结局指标
主要结局
Primary endpoint: comprising major adverse cardiac and cerebrovascular events defined as: 1. efficacy: MACCE - stroke, TIA, peripheral embolism, nonfatal myocardial infarction, cardiovascular and overall mortality; device related thrombosis; and 2. safety: moderate and severe bleedings (type 2-5 BARC).
Primary endpoint: comprising major adverse cardiac and cerebrovascular events defined as: 1. efficacy: MACCE - stroke, TIA, peripheral embolism, nonfatal myocardial infarction, cardiovascular and overall mortality; device related thrombosis; and 2. safety: moderate and severe bleedings (type 2-5 BARC).
次要结局
未报告次要终点
研究者
Clinical Research Support Centre Information Desk
Scientific
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
研究点 (10)
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