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临床试验/NCT00432120
NCT00432120已完成3 期

Clopidogrel Loading Dose for ad-Hoc Percutaneous Coronary Intervention Immediately Following Elective Coronary Angiography: Randomized Multicenter Trial Comparing Pre-Treatment > 6 Hours Before Every Angiography vs. Cath-Lab Administration After Angiography (Just Before Intervention): the PRAGUE-8 Trial.

Charles University, Czech Republic1 个研究点 分布在 1 个国家开始时间: 2006年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
试验地点
1
主要终点
Primary end point was the first clinical occurrence of any of the following: death / periprocedural myocardial infarction / stroke or transient ischemic attack / re-intervention

研究概览

简要总结

Clopidogrel pre-treatment before planned percutaneous coronary intervention was proved to reduce periprocedural complications. However, the vast majority of patients in the current interventional cardiology practice do not undergo planned PCI, but rather "ad-hoc" PCI performed immediately after coronary angiography . Whether clopidogrel should be administered as pre-treatment to all patients undergoing elective CAG with the aim to ensure therapeutic levels at the time of possible ad-hoc PCI is not known.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • Age ≥ 18 years
  • Elective CAG for suspected or proven coronary artery disease (stable forms or fully stabilized acute coronary syndrome)
  • Signed written informed consent

排除标准

  • Thienopyridine treatment in previous two weeks
  • Contraindication for clopidogrel
  • CAG scheduled less than 6 hours after potential randomization
  • Clinically significant bleeding (i.e. with hemoglobin fall by > 50 g/l and/or requiring transfusions or surgery) in previous 3 months.

研究组 & 干预措施

A

Active Comparator

"nonselective" - clopidogrel 600 mg >6 hours before coronary angiography;

干预措施: clopidogrel (Drug)

B

Active Comparator

"selective" - clopidogrel 600 mg in the cath-lab after coronary angiography, only in case of percutaneous coronary intervention

干预措施: clopidogrel (Drug)

结局指标

主要结局

Primary end point was the first clinical occurrence of any of the following: death / periprocedural myocardial infarction / stroke or transient ischemic attack / re-intervention

时间窗: within 7 days

次要结局

  • Secondary end-points were periprocedural troponin elevation (> 3x ULN), TIMI-flow after PCI, bleeding complications and each individual component of the combined primary endpoint(within 7 day)

研究者

发起方
Charles University, Czech Republic
申办方类型
Other

研究点 (1)

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