Prevention of cerebrovascular and cardiovascular Events of ischaemic origin with teRutroban in patients with a history oF ischaemic strOke or tRansient ischaeMic attack

ISRCTN	ISRCTN66157730
DOI	https://doi.org/10.1186/ISRCTN66157730
EudraCT/CTIS number	2005-003700-10
Secondary identifying numbers	CL3-18886-012

Submission date: 22/03/2006
Registration date: 13/06/2006
Last edited: 25/01/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Marie-Germaine Bousser
Scientific

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

Study information

Study design	Randomized double-blind parallel-group study
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	PERFORM
Study objectives	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(s)	First Ethics Committee approval in Italia on 06/12/2005, reference number: 42
Health condition(s) or problem(s) studied	Ischaemic stroke
Intervention	S 18886 (terutroban) versus antithrombotic agent
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Terutroban
Primary outcome measure	Cerebrovascular and cardiovascular events
Secondary outcome measures	Safety criteria
Overall study start date	22/02/2006
Completion date	31/03/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	18000
Key inclusion criteria	Male or female aged at least 55 years with recent history of stroke or transient ischaemic attack
Key exclusion criteria	Haemorrhagic stroke
Date of first enrolment	22/02/2006
Date of final enrolment	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

Study participating centre

Hopital Lariboisiere

Paris
75010
France

Sponsor information

Institut de Recherches Internationales Servier (France)
Industry

50 rue Carnot
Suresnes
92284
France

Website	http://www.servier.com/
"ROR"	https://ror.org/034e7c066

Funders

Funder type

Industry

Institut de Recherches Internationales Servier (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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 plan	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.

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Basic results			No	No
Results article	results	11/06/2011	Yes	No
Results article	results	01/08/2014	Yes	No
Results article	results	01/04/2016	Yes	No
Results article	results	01/04/2017	Yes	No

Editorial Notes

25/01/2018: Publication plan and IPD sharing statement added.
14/12/2017: results summary added. Publication reference added.
18/03/2016: Publication reference added.