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临床试验/NCT00776633
NCT00776633Unknown4 期

Intracoronary Stenting and Antithrombotic Regimen: Testing of a Six-week Versus a Six-month Clopidogrel Treatment Regimen in Patients With Concomitant Aspirin and Oral Anticoagulant Therapy Following Drug-eluting Stenting

Deutsches Herzzentrum Muenchen3 个研究点 分布在 2 个国家目标入组 614 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
614
试验地点
3
主要终点
Composite of death, myocardial infarction, definite stent thrombosis, stroke or major bleeding.

研究概览

简要总结

The investigators hypothesize that reducing the duration of clopidogrel therapy from 6 months to 6 weeks after DES implantation is associated with improved clinical outcomes in patients on ASA and an oral anticoagulant.

详细描述

The introduction of drug-eluting stents (DES) was associated not only with a widening of the indication for percutaneous coronary intervention (PCI) but also with longer antithrombotic therapy duration. Dual antiplatelet therapy with ASA and a thienopyridine is very efficient in preventing adverse events after coronary stenting but it is inferior to oral anticoagulation (OAC) to reduce the risk of stroke in patients with atrial fibrillation. OAC is also superior to antiplatelet therapy in patients with mechanical heart valves and the therapy of choice for the treatment of deep vein thrombosis and pulmonary embolism. OAC is also administered for left ventricular thrombi and low ejection fraction. There is an increasing number of patients undergoing coronary stenting who are in need of life-long anticoagulation therapy and would therefore require a triple therapy consisting of aspirin, clopidogrel and oral anticoagulation. As oral anticoagulation and antithrombotic therapy impair primary and secondary hemostasis there are concerns that adding warfarin to dual antiplatelet therapy might cause increased bleeding rates. Several studies have retrospectively assessed efficacy and safety in patients receiving a triple therapy with various results: major bleeding rates varied from 3,1%-14,9% with total bleeding rates up to 27,5%. Prospective randomized data on this topic are not available. Therefore the aim of this study is to compare a 6 week versus a 6 month triple therapy after DES implantation.

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

  • Patients with an indication for oral anticoagulation and a DES implantation.
  • Informed, written consent by the patient or her/his legally-authorized representative for participation in the study.

排除标准

  • Age ≤18 years
  • Previous stent thrombosis
  • DES in left main

研究组 & 干预措施

Short triple

Experimental

6 weeks triple therapy

干预措施: aspirin (Drug)

Short triple

Experimental

6 weeks triple therapy

干预措施: clopidogrel (Drug)

Short triple

Experimental

6 weeks triple therapy

干预措施: oral anticoagulation (Drug)

Long triple

Active Comparator

6 months triple therapy

干预措施: aspirin (Drug)

Long triple

Active Comparator

6 months triple therapy

干预措施: clopidogrel (Drug)

Long triple

Active Comparator

6 months triple therapy

干预措施: oral anticoagulation (Drug)

结局指标

主要结局

Composite of death, myocardial infarction, definite stent thrombosis, stroke or major bleeding.

时间窗: 9 months

次要结局

  • Ischemic complications (composite of cardiac death, myocardial infarction, stent thrombosis or ischemic stroke)(9 months)
  • Bleeding complications (Major bleeding)(9 months)

研究者

发起方
Deutsches Herzzentrum Muenchen
申办方类型
Other
责任方
Sponsor

研究点 (3)

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