EUCTR2005-003700-10-ES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
aboratorios Servier S.L.0 个研究点目标入组 18,000 人开始时间: 2005年12月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 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 < 3 months before randomisation,
- •- Or transient ischaemic attack (TIA) with at least symptoms of motor weakness 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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