EUCTR2021-006127-17-PL进行中（未招募）1 期
Optimal Antiplatelet Treatment to Achieve Stroke Avoidance and Fall inBleeding Events following Left Atrial Appendage Closure – Chronic KidneyDisease (SAFE LAAC CKD). Comparative Health Effectiveness AncillaryStudy – PILOT - SAFE LAAC CKD
arodowy Instytut Kardiologii Stefana kardynala Wyszynskiego- Panstwowy Instytut Badawczy0 个研究点目标入组 80 人开始时间: 2022年3月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Successful percutaneous left atrial appendage occlusion with
- •Amplatzer or WATCHMAN devices within 37 days prior to randomization
- •2. End-stage renal disease treated with chronic hemodialysis or chronic peritoneal dialysis
- •3. Age >= 18 yrs
- •4. Participant is willing to comply with all aspects of the protocol
- •including the assigned treatment strategy and follow-up visits
- •5. The participant is willing to give written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Any indication to chronic antiplatelet therapy other than atrial
- •fibrillation or left atrial appendage occlusion.
- •2. Indications to chronic anticoagulation
- •3. Known allergy to clopidogrel of acetylsalicylic acid
- •4. Diagnosis of coagulation disorders
- •5. Peridevice leaks greater than 5mm
- •6. Thrombus in the left atrium on the qualifying imaging of the left
- •7. Life expectancy less than the duration of the trial due to
- •noncardiovascular comorbidity
- •8. Enrollment into a competing trial using a non-approved devices or
- •drugs - currently and up to 3 months prior to enrolment
- •9. 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.
研究者
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