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临床试验/EUCTR2005-003700-10-GR
EUCTR2005-003700-10-GR进行中(未招募)不适用

Prevention of cerebrovascular and cardiovascular Events of ischaemic origin with teRutroban in patients with a history oF ischaemic strOke or tRansient ischaeMic attack.The PERFORM Study.An international, randomised, double-blind, two parallel group study comparing terutroban 30 mg o.d. versus aspirin 100 mg o.d. administered orally for a 3-year mean duration (event driven trial). - PERFORM

Institut de Recherches Internationales Servier0 个研究点目标入组 18,000 人开始时间: 2006年10月9日最近更新:
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
18,000

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - Women or men, age superior or equal to 55 years,
  • - Ischaemic stroke (IS), or arterial retinal ischaemic event (ARIE) confirmed by an ophtalmologist, > 48 hours and inferior or equal to 3 months before randomisation,
  • - Or transient ischaemic attack (TIA) with at least symptoms of motor weakness in the limbs and/or aphasia, inferior or equal to 8 days before randomisation,
  • - Neurologically, clinically and haemodynamically stable at inclusion,
  • - All patients (IS/ARIE and TIA), having had a Computerised Tomography-scan (CT-scan) or a Magnetic Resonance Imaging (MRI) ruling out intracranial haemorrhage or any non-ischaemic neurological disease,
  • - Giving informed consent.
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - Cognitive impairment interfering with the possibility of obtaining patient's informed consent and/or with the conduct of the study,
  • - Known dementia,
  • - Pregnancy, breastfeeding or possibility of becoming pregnant during the study,
  • - Criteria related to the qualifying event or other current medical conditions (detailed in the study protocol),
  • - Criteria related to bleeding risk (detailed in the study protocol),
  • - Criteria related to treatments (detailed in the study protocol).

研究者

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