NCT04708587招募中不适用
Appropriate Duration of Anti-Platelet straTegy in Patients With Advance Chronic Kidney Disease After New Generation Drug Eluting Stents (ADAPT-CKD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Net Clinical adverse event (NACE)
研究概览
简要总结
The purpose of this prospective randomized clinical trial is to compare the clinical outcomes according to the duration of aspirin and clopidogrel or prasugrel with dual anti-platelet therapy after percutaneous coronary intervention in patients with advanced chronic kidney disease using a new generation drug eluting stents.
详细描述
Prospective, open label, multicenter randomized clinical trial
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
- 年龄范围
- 19 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 19 years old
- •Chronic Renal Failure Stage IIIb, IV, V (CKD-EPI eGFR <45 / <30 / <15 or dialysis)
- •Patients treated with a new generation drug eluting stent.
- •Patients who signed consent form
排除标准
- •Over 85 years old
- •Patients with high risk of bleeding 1) History of hemorrhagic stroke 2) Stroke, dementia or central nervous system damage within 1 year 3) Head trauma or brain surgery within 6 months 4) Tumor in the skull 5) If aortic dissection is suspected 6) Internal bleeding within 6 weeks 7) In case of active bleeding or bleeding disorder 8) In case of major surgery, trauma or bleeding within 3 weeks
- •Patients who need oral anticoagulant
- •Pregnant women or women of childbearing age
- •Life expectancy is less than 1 year
- •Patients with a history of intracranial bleeding
- •Moderate to severe hepatic impairment (Child-Pugh class B or C)
研究组 & 干预措施
dual anti-platelet therapy at least 6 months
Active Comparator
干预措施: dual anti-platelet therapy at least 6 months (Drug)
dual anti-platelet therapy 3months or less
Experimental
干预措施: dual anti-platelet therapy 3months or less (Drug)
结局指标
主要结局
Net Clinical adverse event (NACE)
时间窗: 1 year
Net Clinical adverse event (NACE) : all cause death, myocardial infarction, stent thrombosis, stroke, major bleeding (BARC 3,5)
次要结局
- The rate of Each component of Cardiovascular death(1 year)
- myocardial infarction(1 year)
- stent thrombosis (definite, probable)(1 year)
- stroke (ischemic, hemorrhagic)(1 year)
- The rate of Major adverse cardiovascular events (MACE), defined as a composite of cardiovascular death, myocardial infarction, stent thrombosis (definite or probable), or target vessel revascularization(1 year)
- The rate of Composite ischemic outcomes, defined as a composite of cardiovascular death, myocardial infarction, stent thrombosis (definite or probable), or ischemic stroke(1 year)
- The rate of major or clinically relevant nonmajor bleeding, defined as BARC type 2,3,5 bleeding, Fatal bleeding or intracranial hemorrhage(1 year)
- The rate of Subgroup analysis of primary endpoint, key secondary efficacy, safety endpoint and, revascularization according to the CKD stage (lllb vs. IV or V)(1 year)
- The rate of Target lesion revascularization(1 year)
- The rate of Target vessel revascularization(1 year)
- The rate of Subgroup analysis of primary endpoint, key secondary efficacy, safety endpoint and, revascularization according to the clinical presentation (chronic coronary syndrome vs. acute coronary syndrome)(1 year)
- he rate of Subgroup analysis of primary endpoint, key secondary efficacy, safety endpoint and, revascularization according to the type of Stent (polymer-free vs. durable-polymer)(1 year)
研究者
研究点 (1)
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