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ISRCTN
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ISRCTN66157730
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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The PERFORM study
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Serial number at source
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CL3-18886-012
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Study hypothesis
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To demonstrate the superiority of terutroban over a marketed drug (antithrombotic agent) in reducing the number of cerebrovascular and cardiovascular events in patients with cerebrovascular diseases
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Lay summary
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Ethics approval
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First Ethics Committee approval in Italia on 06/12/2005, reference number: 42
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Study design
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Randomized, double-blind, parallel-group study
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Countries of recruitment
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International
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Disease/condition/study domain
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Ischaemic stroke
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Participants - inclusion criteria
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Male or female aged at least 55 years with recent history of stroke or transient ischaemic attack
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Participants - exclusion criteria
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Haemorrhagic stroke
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Anticipated start date
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22/02/2006
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Anticipated end date
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31/03/2010
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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18000
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Interventions
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S 18886 (terutroban) versus antithrombotic agent
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Primary outcome measure(s)
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Cerebrovascular and cardiovascular events
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Secondary outcome measure(s)
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Safety criteria
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Sources of funding
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Institut de Recherches Internationales Servier (France)
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Trial website
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Publications
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Contact name
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Prof
Marie-Germaine
Bousser
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Address
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Hopital Lariboisiere
Service de Neurologie
2 Rue Ambroise Pare
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City/town
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Paris
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Zip/Postcode
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75010
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Country
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France
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Sponsor
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Institut de Recherches Internationales Servier (France)
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Address
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6 Place des Pléiades
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City/town
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Courbevoie
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Zip/Postcode
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92415
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Country
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France
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Date applied
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22/03/2006
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Last edited
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18/02/2008
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Date ISRCTN assigned
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13/06/2006
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