Twelve vs 24 Months of Dual Antiplatelet Therapy in Patients With Coronary Revascularization for In-stent Restenosis
2015年3月27日 更新者：Yujie Zhou、Beijing Anzhen Hospital
Twelve Versus 24 Months of Dual Antiplatelet Therapy in Patients With Percutaneous Coronary Intervention for In-stent Restenosis
Patients undergoing the percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) are enrolled.
All patients will be randomized to receive either 12 months or 24 months of dual antiplatelet therapy with a P2Y12 receptor antagonist in addition to aspirin, all patients continue receiving aspirin indefinitely.
The primary efficacy end points of this study are the incidence of a composite end point including all cause deaths, myocardial infarction, the incidence of Academic Research Consortium defined definite or probable stent thrombosis and stroke (MACCE) at 24 months.
The primary safety end point is the incidence of GUSTO moderate or severe bleeding.
研究概览
地位
未知
条件
详细说明
The ISR-DAPT Study is a multicenter, randomized controlled trial that will enroll 1000 subjects treated with percutaneous coronary intervention (PCI) for in-stent restenosis.
All patients will be randomized to receive either 12 months or 24 months of dual antiplatelet therapy with a P2Y12 receptor antagonist in addition to aspirin after index procedure.
All patients continue receiving aspirin indefinitely.
The primary efficacy end points of this study are the incidence of a composite end point including all cause deaths, myocardial infarction, the incidence of Academic Research Consortium defined definite or probable stent thrombosis and stroke (MACCE) at 24 months.
The primary safety end point is the incidence of GUSTO moderate or severe bleeding at 24 months.
研究类型
介入性
注册 (预期的)
1000
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Beijing
-
Beijing、Beijing、中国、100029
- Beijing Anzhen Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Subjects 18-80 years of age
- Undergoing percutaneous intervention with stent deployment for the treatment of in-stent restenosis
Exclusion Criteria:
- Pregnant women
- Planned surgery necessitating discontinuation of antiplatelet therapy within the 24 months after enrollment
- Current medical condition with a life expectancy of <2 years
- Concurrent enrollment in another device or drug study whose protocol specifically rules out concurrent enrollment
- Subjects on warfarin or similar anticoagulant therapy
- Subjects with hypersensitivity or allergies to one of the drugs
- Subjects unable to give informed consent
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：24 months of P2Y12 receptor antagonist
Receive 24 months of dual antiplatelet therapy (with a P2Y12 receptor antagonist in addition to aspirin) after index procedure.
All subjects receive aspirin for the duration of study.
|
All subjects will be received 24 months of dual antiplatelet therapy with a P2Y12 receptor antagonist (clopidogrel/prasugrel/ticagrelor) in addition to aspirin.
The maintenance dose of aspirin is 100 mg daily, to be taken indefinitely.
|
|
安慰剂比较：12 months of P2Y12 receptor antagonist
Receive 12 months of dual antiplatelet therapy (with a P2Y12 receptor antagonist in addition to aspirin) after index procedure.
All subjects receive aspirin for the duration of study.
|
The maintenance dose of aspirin is 100 mg daily, to be taken indefinitely.
All subjects will be received 12 months of dual antiplatelet therapy with a P2Y12 receptor antagonist (clopidogrel/prasugrel/ticagrelor) in addition to aspirin.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
MACCE
大体时间：24 months
|
Incidence of a composite end point including all cause deaths, myocardial infarction, the incidence of Academic Research Consortium defined definite or probable stent thrombosis and stroke (MACCE) at 24 months.
|
24 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Safety end point assessed by incidence of GUSTO moderate or severe bleeding.
大体时间：24 months
|
Specifically, bleeding complications are classified as severe if they are intracerebral or if they result in substantial hemodynamic compromise requiring treatment.
Moderate bleeding is defined by the need for transfusion.
|
24 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Yujie Zhou, MD, PhD、Beijing Anzhen Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年1月1日
初级完成 (预期的)
2015年6月1日
研究完成 (预期的)
2015年6月1日
研究注册日期
首次提交
2015年3月23日
首先提交符合 QC 标准的
2015年3月27日
首次发布 (估计)
2015年3月30日
研究记录更新
最后更新发布 (估计)
2015年3月30日
上次提交的符合 QC 标准的更新
2015年3月27日
最后验证
2015年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.