Prevention of cerebrovascular and cardiovascular Events of ischaemic origin with teRutroban in patients with a history oF ischaemic strOke or tRansiet 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 3-year mean duration (event driven trial) - The PERFORM study

• Conditions: Ischaemic stroke or transiet ischaemic attack; MedDRA version: 14.1Level: PTClassification code 10043647Term: Thrombotic strokeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2005-003700-10-IT
• Lead Sponsor: INSTITUT DE RECHERCHES INTERNATIONALES SERVIER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-06
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18000

Inclusion Criteria

Women or men, age superior or ugual 55 years,- Ischaemic stroke (IS) or arterial retinal ischaemic event (ARIE) confirmed by an optalmologist, > 48 hours and < 3 months before randomisation,- Or transiet ischaemic attak (TIA) with at least symptoms of motor weakness and/or aphasia, inferior or equal to 8 days before randomisation,- Neurologiacally, clinically and haemodynamically stable at inclusion,- All patients (IS/ARIE and TIA), having had a Computerised Tomography-scan (CT-scan) or a Magnetic esonance Imaging (MRI) ruling out intracranial haemorrhage or any non-ischaemic neurological disease,- Guiving informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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

Exclusion Criteria

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),- Crieria related to bleeding risk (detailed in the study protocol),- Criteria related to treatments (detailed in the study protocol)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to demonstrate the superiority of S 18886 30 mg o.d. over aspirin 100 mg o.d., in reducing cerebrovascular and cardiovascular events of ischaemic origin (primary efficacy end point: composite of ischaemic stroke, myocardial infarction, other vasculare death) in patients with a history of ischaemic stroke or transiet ischaemic attack.;Secondary Objective: to asses the effects of S 18886 on the other efficacy endpoints and its safety, as well as on prevention of cognitive decline and dementia.;Primary end point(s): First occurence of an event in the composite of ischaemic stroke, myocardial infarction, other vascular death (excluding haemorrhagic death of any origin).