Condition category
Circulatory System
Date applied
22/03/2006
Date assigned
13/06/2006
Last edited
18/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Trial website

Contact information

Type

Scientific

Primary contact

Prof Marie-Germaine Bousser

ORCID ID

Contact details

Hopital Lariboisiere
Service de Neurologie
2 Rue Ambroise Pare
Paris
75010
France

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

http://www.servier.com/

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25070960
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26979864

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes

18/03/2016: Publication reference added.