跳至主要内容
临床试验/NCT00418860
NCT00418860已完成不适用

The Optimal Duration of Dual Antiplatelet Therapy After Implantation of Endeavor Stent in the Patients With Coronary Artery Disease (DATE Registry)

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2006年9月最近更新:
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
入组人数
1,200
试验地点
1
主要终点
Incidence of definite stent thrombosis by Academic Research Consortium Proposed Standard

研究概览

简要总结

The purpose of this study to determine whether the dual antiplatelet therapy (aspirin and clopidogrel) for 3 months after coronary implantation of zotarolimus-eluting stent is safe in terms of death, myocardial infarction, or stent thrombosis.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with clinically significant de novo coronary artery disease
  • Stenting only with Endeavor® stents
  • The sum of stent length is less than 60 mm for one lesion. The sum of stent length in multiple lesions does not matter.

排除标准

  • Cardiogenic shock
  • ST-elevation myocardial infarction within 48 hours of symptom onset
  • Prior implantation of drug-eluting stents
  • Left ventricular dysfunction (echocardiographic left ventricular ejection fraction < 25%)
  • Stenting both branch of bifurcation lesion
  • Left main trunk lesion
  • Graft vessels
  • Patients who have to receive clopidogrel due to other conditions
  • Patients who have to receive warfarin, cilostazol or other antiplatelet therapy
  • Patient with chronic renal failure (S-Cr > 2.0 mg/dl)
  • Hypersensitivity to clopidogrel or aspirin
  • Expectant survival less than 1 year
  • Women who plan to become pregnant
  • Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months)
  • Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

研究组 & 干预措施

A

Experimental

干预措施: Aspirin, Clopidogrel (Drug)

结局指标

主要结局

Incidence of definite stent thrombosis by Academic Research Consortium Proposed Standard

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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