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临床试验/EUCTR2022-001067-27-PT
EUCTR2022-001067-27-PT进行中(未招募)1 期

A multicenter, international, randomized, placebo controlled, double-blind, parallel group and event driven Phase 3 study of the oral FXIa inhibitor asundexian (BAY 2433334) for the prevention of ischemic stroke in male and female participants aged 18 years and older after an acute non-cardioembolic ischemic stroke or high-risk TIA - Oral faCtor Eleven A iNhibitor asundexIan as novel anti-thrombotiC – STROKE study

Bayer AG0 个研究点目标入组 9,300 人开始时间: 2023年1月12日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
Bayer AG
入组人数
9,300

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Participants must be = 18 years of age
  • 2. Acute non-cardioembolic stroke or high-risk TIA
  • 3. Systemic or cerebrovascular atherosclerosis or acute non-lacunar infarct
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 3100
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 6200

排除标准

  • 1. Ischemic stroke = 7 days before the index stroke event
  • 2. Index stroke following procedures or strokes due to other rare causes
  • 3. History of atrial fibrillation/flutter, left ventricular thrombus, mechanic valve or other cardioembolic source of stroke requiring anticoagulation

研究者

发起方
Bayer AG

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