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临床试验/NCT00822536
NCT00822536已完成4 期

Optimal Duration of Dual Antiplatelet Therapy After Drug Eluting Stent (DES) Implantation

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 1,798 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
1,798
试验地点
1
主要终点
Composite criteria : death, non fatal myocardial infarction, non fatal stroke and severe bleeding

研究概览

简要总结

To compare treatment with aspirin alone versus the combined antiplatelet treatment aspirin and clopidogrel after 12 months of combined antiplatelet treatment following drug-eluting stent (DES) implantation.

详细描述

Drug-eluting stents (DES) substantially reduce restenosis compared with bare metal stents and represent a significant advance in percutaneous coronary interventions (PCIs). Accordingly, DES have been rapidly adopted into practice and are currently used in the majority of PCI procedures. Despite their rapid acceptance, DES are not without limitations. In particular, patients who receive DES (like those who receive conventional bare metal stents) remain at risk of a 1% to 2% incidence of stent thrombosis, which is often associated with devastating consequences like death or myocardial infarction. Understanding and eliminating mediators of stent thrombosis are thus important goals for optimizing the clinical benefits of DES. Delayed endothelial coverage after DES implantation has been demonstrated and is thought to prolong the window of vulnerability to stent thrombosis. Consequently, current recommendations for DES are: dual antiplatelet therapy for at least 12 months in patients at low risk of bleeding, especially with " off-label " use. Because of rare but severe very late stent thrombosis, the dual antiplatelet therapy is more and more prescribed in clinical practice for several years.But it has been clearly demonstrated that the combination of aspirin and clopidogrel (the thienopyridine the most used) significantly increase the rate of severe and moderate bleedings when compared to aspirin alone. This is important if we consider the possibility or the necessity to prolong the combined antiplatelet therapy after stent implantation.ProposalTo compare treatment with aspirin alone versus the combined antiplatelet treatment with aspirin and clopidogrel after 12 months of combined antiplatelet treatment after DES implantation

NB : On the decision of the sponsor, the latest patient monitoring was advanced to September 30, 2014 instead of January 2015.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

1

Active Comparator

Bi therapy : aspirin/ clopidogrel

干预措施: Aspirin and Clopidogrel (Drug)

2

Active Comparator

Monotherapy: aspirin

干预措施: Aspirin (Drug)

结局指标

主要结局

Composite criteria : death, non fatal myocardial infarction, non fatal stroke and severe bleeding

时间窗: At each visit (every 6 months) with Follow-up of 3 years

次要结局

  • Non fatal myocardial infarction(At each visit (every 6 months) with Follow-up of 3 years)
  • Death(At each visit (every 6 months) with Follow-up of 3 years)
  • Non fatal stroke(At each visit (every 6 months) with Follow-up of 3 years)
  • Target lesion revascularization(At each visit (every 6 months) with Follow-up of 3 years)
  • Severe bleeding(At each visit (every 6 months) with Follow-up of 3 years)
  • Stent thrombosis (ARC définition)(At each visit (every 6 months) with Follow-up of 3 years)
  • Moderate bleeding (ISTH definition)(At each visit (every 6 months) with Follow-up of 3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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