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

• Conditions: Ischaemic stroke or transient ischaemic attack; MedDRA version: 7.0Level: PTClassification code 10008190

• Registration Number: EUCTR2005-003700-10-HU
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-03
• Last Update Posted: 14 August 2012

Recruitment & Eligibility

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

Inclusion Criteria

- 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

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),
- Criteria 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 vascular death) in patients with a history of ischaemic stroke or transient ischaemic attack.<br>;Secondary Objective: To assess the effects of S 18886 on the other efficacy endpoints and its safety, as well as on prevention of cognitive decline and dementia.<br>;Primary end point(s): First occurrence of an event in the composite of ischaemic stroke, myocardial infarction, other vascular death (excluding haemorrhagic death of any origin).