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临床试验/NCT02675205
NCT02675205已完成3 期

Ticagrelor Versus Clopidogrel for Platelet Inhibition in Patients Undergoing Neurovascular Stenting for Intracranial Aneurysm

Fondation Ophtalmologique Adolphe de Rothschild1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年12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
入组人数
100
试验地点
1
主要终点
proportion of patients requiring at least one change of drug or dose adjustment to achieve platlet functional inhibition

研究概览

简要总结

Part of interventional neuroradiology procedures for the treatment of selected cerebral aneurysms are now based on stenting. To reduce thromboembolic events, dual antiplatelet therapy (APT) combining aspirin and clopidogrel is proposed with close monitoring, since 1/3 of the patients are low responders due to variation of the biological response to clopidogrel . Ticagrelor is used by few teams but has never been evaluated in a randomized controlled trial. It could be an option for APT due to more reproducible response with less interindividual variability and reduced monitoring. The aim of this study is to demonstrate the interest of ticagrelor for the dual APT for platelet inhibition, in patients undergoing neurovascular stenting for cerebral aneurysm.

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

  • unruptured cerebral aneurysm
  • elective endovascular treatment
  • stenting required
  • dual antiplatelet therapy required

排除标准

  • 未提供

研究组 & 干预措施

clopidogrel-aspirin

Active Comparator

clopidogrel: 75mg and aspirin 250 mg once a day for 15 weeks; prescribed 3 weeks before surgery.

干预措施: Clopidogrel (Drug)

clopidogrel-aspirin

Active Comparator

clopidogrel: 75mg and aspirin 250 mg once a day for 15 weeks; prescribed 3 weeks before surgery.

干预措施: aspirin (Drug)

ticagrelor-aspirin

Experimental

Ticagrelor: 90 mg bid and aspirin 250 mg once a day for 15 weeks; prescribed 3 weeks before surgery

干预措施: Ticagrelor (Drug)

ticagrelor-aspirin

Experimental

Ticagrelor: 90 mg bid and aspirin 250 mg once a day for 15 weeks; prescribed 3 weeks before surgery

干预措施: aspirin (Drug)

结局指标

主要结局

proportion of patients requiring at least one change of drug or dose adjustment to achieve platlet functional inhibition

时间窗: 4 months

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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