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临床试验/NCT00781573
NCT00781573已完成不适用

Study of Optimal Clopidogrel Duration in Patients Receiving Drug Eluting Stents (SCORE Trial)

North Texas Veterans Healthcare System3 个研究点 分布在 3 个国家目标入组 167 人开始时间: 2008年9月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
167
试验地点
3
主要终点
Death and Myocardial Infarction

研究概览

简要总结

Although the optimal duration of clopidogrel (an anti-platelet agent) therapy has been established after bare metal stent implantation in the blood vessels of the heart, there is lack of consensus regarding the optimal duration of therapy after implantation of a drug eluting stents (DES). Current American College of Cardiology guidelines recommend clopidogrel use for at least one year in the absence of contraindications after DES implantation, while recognizing that the optimal duration remains unknown. While an extended clopidogrel therapy (that is beyond the current 1 year recommendation) may increase bleeding complication, it may reduce the rates of adverse cardiovascular events like heart attacks and repeat revascularization procedures. A clinical trial which randomizes patients with an uneventful one year course after a DES implantation, to an additional year of clopidogrel and aspirin therapy versus aspirin alone, will be able to answer the important question about the role of extended (2y) dual anti-platelet therapy with clopidogrel and aspirin after DES implants. The investigators hypothesize that clopidogrel discontinuation at 1 year post-DES implantation is associated with an increase in cardiovascular events during the one year of follow-up period.

详细描述

SCORE is a multicenter, prospective randomized study of post-percutaneous coronary intervention (PCI) patients with an uneventful 1 year post-PCI course on dual anti-platelet therapy (DAPT) with clopidogrel and aspirin. Patient will be randomized to an additional 1 year of DAPT (treatment arm) vs. aspirin alone (control arm)to assess the following endpoints during the 1 year follow-up period:

  1. Death / Myocardial infarction (MI) (Primary end-point)
  2. Combined endpoints of death, myocardial infarction, repeat revascularization, stroke, and major/minor bleeding (Secondary end-point)

During the year of follow up, subjects will be contacted once every three months. This will enable us to track study endpoints in the study population. In addition the patients' medical records will be screened to investigate if any of the aforementioned endpoints have been reached.

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

入选标准

  • Post-PCI patients receiving at least 1 DES
  • Completed 9-15 months follow-up free of MI, repeat revascularization
  • Able to provide informed consent
  • Have continued dual anti-platelet therapy with aspirin and clopidogrel for 1 year post-PCI

排除标准

  • Patients allergic to aspirin
  • Patients with aspirin resistance
  • Patients with allergy to clopidogrel
  • Patients on concomitant warfarin therapy
  • History of bleeding diathesis, coagulopathy, and/or platelet count < 100,000 cubic mm
  • Patients with a life expectancy less than 1 year due to active cancers (except basal cell carcinoma)
  • Pregnancy

研究组 & 干预措施

1

Experimental

Clopidogrel (75 mg/day) is continued for another year at the completion of the initial year of clopidogrel and aspirin administration post DES implantation

干预措施: Clopidogrel (Drug)

结局指标

主要结局

Death and Myocardial Infarction

时间窗: 12 months

次要结局

  • Combined endpoints of death, myocardial infarction, repeat revascularization, stroke and major/minor bleeding(12 months)

研究者

发起方
North Texas Veterans Healthcare System
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Subhash Banerjee

Acting chief of Cardiology

North Texas Veterans Healthcare System

研究点 (3)

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