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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003700-10-BE

Enrollment

18000

Registered

2005-11-24

Start date

2006-01-27

Completion date

Unknown

Last updated

2012-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischaemic stroke or transient ischaemic attack MedDRA version: 7.0 Level: PT Classification code 10008190

Interventions

Product Code: S 18886 Pharmaceutical Form: Coated tablet INN or Proposed INN: terutroban CAS Number: 165538-40-9 Current Sponsor code: S 18886-2 Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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).

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the superiority of S 18886 30 mg o.d. over aspirin 100 mg o.d., in reducing cerebrovascular and cardiovascular events of ischaemic origin (primary efficacy end point: composite of ischaemic stroke, myocardial infarction, other vascular death) in patients with a history of ischaemic stroke or transient ischaemic attack. ;Secondary Objective: To assess the effects of S 18886 on the other efficacy endpoints and its safety, as well as on prevention of cognitive decline and dementia. ;Primary end point(s): First occurrence of an event in the composite of ischaemic stroke, myocardial infarction, other vascular death (excluding haemorrhagic death of any origin).	—

Measure

Time frame

Main Objective: To demonstrate the superiority of S 18886 30 mg o.d. over aspirin 100 mg o.d., in reducing cerebrovascular and cardiovascular events of ischaemic origin (primary efficacy end point: composite of ischaemic stroke, myocardial infarction, other vascular death) in patients with a history of ischaemic stroke or transient ischaemic attack. ;Secondary Objective: To assess the effects of S 18886 on the other efficacy endpoints and its safety, as well as on prevention of cognitive decline and dementia. ;Primary end point(s): First occurrence of an event in the composite of ischaemic stroke, myocardial infarction, other vascular death (excluding haemorrhagic death of any origin).

—

Countries

Belgium, Czech Republic, Finland, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Portugal, Slovenia, Spain, Sweden, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026