Additional identifiers
EudraCT number
2005-003700-10
ClinicalTrials.gov number
Protocol/serial number
CL3-18886-012
Study information
Scientific title
Prevention of cerebrovascular and cardiovascular Events of ischaemic origin with teRutroban in patients with a history oF ischaemic strOke or tRansient ischaeMic attack
Acronym
PERFORM
Study hypothesis
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
Ethics approval
First Ethics Committee approval in Italia on 06/12/2005, reference number: 42
Study design
Randomized double-blind parallel-group study
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Ischaemic stroke
Intervention
S 18886 (terutroban) versus antithrombotic agent
Intervention type
Drug
Phase
Not Applicable
Drug names
Terutroban
Primary outcome measures
Cerebrovascular and cardiovascular events
Secondary outcome measures
Safety criteria
Overall trial start date
22/02/2006
Overall trial end date
31/03/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Male or female aged at least 55 years with recent history of stroke or transient ischaemic attack
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
18000
Participant exclusion criteria
Haemorrhagic stroke
Recruitment start date
22/02/2006
Recruitment end date
31/03/2010
Locations
Countries of recruitment
Austria, Belgium, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Finland, France, Greece, Hong Kong, India, Ireland, Korea, South, Lithuania, Mexico, Morocco, Netherlands, New Zealand, Norway, Portugal, Romania, Singapore, Slovenia, Sweden, Taiwan, Tunisia, Ukraine
Trial participating centre
Hopital Lariboisiere
Paris
75010
France
Sponsor information
Organisation
Institut de Recherches Internationales Servier (France)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Institut de Recherches Internationales Servier (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication plan:
All phases - Interventional studies ending before 01/10/2018: Summary results will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study.
All phases - Interventional studies ending after 01/10/2018: Summary results and a lay summary will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study.
Phase 3 only - The results will be published in scientific literature within 18 months after the end of the study.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com/ if a Marketing Authorisation has been granted after 2014.
Intention to publish date
Participant level data
Available on request
Results - basic reporting
http://clinicaltrials.servier.com/wp-content/uploads/CL3-18886-012_synopsis_report.pdf
Publication summary
2011 results in: https://www.ncbi.nlm.nih.gov/pubmed/21616527
2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/25070960
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/26979864
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28088798
Publication citations
-
Results
Bots ML, Ford I, Lloyd SM, Laurent S, Touboul PJ, Hennerici MG, , Thromboxane prostaglandin receptor antagonist and carotid atherosclerosis progression in patients with cerebrovascular disease of ischemic origin: a randomized controlled trial., Stroke, 2014, 45, 8, 2348-2353, doi: 10.1161/STROKEAHA.114.004775.
-
Results
Gonzalez-Valcarcel J, Sissani L, Labreuche J, Bousser MG, Chamorro A, Fisher M, Ford I, Fox KM, Hennerici MG, Mattle HP, Rothwell PM, Steg PG, Vicaut E, Amarenco P, Paracetamol, Ibuprofen, and Recurrent Major Cardiovascular and Major Bleeding Events in 19 120 Patients With Recent Ischemic Stroke, Stroke, 2016.