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Clinical Trials/EUCTR2005-003700-10-DE
EUCTR2005-003700-10-DE
Active, not recruiting
Not Applicable

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 sites18,000 target enrollmentJune 19, 2006
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ConditionsIschaemic stroke or transient ischaemic attackMedDRA version: 7.0Level: PTClassification code 10008190
DrugsAspirin Protect

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ischaemic stroke or transient ischaemic attack
Sponsor
Institut de Recherches Internationales Servier
Enrollment
18000
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 19, 2006
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

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 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

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).

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Not Applicable
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). - PERFORMIschaemic stroke or transient ischaemic attackMedDRA version: 7.0Level: PTClassification code 10008190
EUCTR2005-003700-10-BEInstitut de Recherches Internationales Servier18,000
Active, not recruiting
Not Applicable
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
EUCTR2005-003700-10-LTInstitut de Recherches Internationales Servier18,000
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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
EUCTR2005-003700-10-SEInstitut de Recherches Internationales Servier18,000
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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). - PERFORMIschaemic stroke or transient ischaemic attackMedDRA version: 7.0Level: PTClassification code 10008190
EUCTR2005-003700-10-HUInstitut de Recherches Internationales Servier18,000
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Not Applicable
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). - PERFORMIschaemic stroke or transient ischaemic attackMedDRA version: 7.0Level: PTClassification code 10008190
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