null - FindTrial

Effects of terutroban versus aspirin on composition of atherosclerotic plaque in patients undergoing a carotid endarterectomy.A multicentre, randomised, double blind, two parallel group study comparing terutroban 30 mg o.d. versus aspirin 100 mg o.d. administered orally. -

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000176-17-FR

Enrollment

Unknown

Registered

2007-07-23

Start date

2007-09-07

Completion date

Unknown

Last updated

2017-05-08

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 Term:

Interventions

Product Name: S18886 Product Code: S18886 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: terutroban CAS Number: 165538-40-9 Concentration unit: mg milligram(s) Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age = 18 years, - Men, - Post-menopausal women or with effective contraception, - Patients with planned, non-urgent endarterectomy for clinically asymptomatic carotid artery stenosis, - Having given informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Anaemia: haemoglobin <11.0 g/dL (male); <10.0 g/dL (female), - Uncontrolled hypertension at the time of randomisation, treated or not treated, - Use of any forbidden traitement between selection and inclusion visits, - History of aspirin-related haemorrhage or history of true aspirin hypersensitivity.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effects of terutroban/S 18886 30 mg o.d. versus aspirin 100 mg o.d. in patients undergoing a carotid endarterectomy on the expression of atherosclerosis markers in carotid plaque removed during endarterectomy.;Secondary Objective: - To assess the effects of S 18886 on morphology of the carotid plaque, on blood atherosclerosis markers, - To assess the cerebral vasoreactivity in this population.;Primary end point(s): Expression of biochemical markers of inflammation in carotid plaque, removed during endarterectomy.	—

Measure

Time frame

Main Objective: To evaluate the effects of terutroban/S 18886 30 mg o.d. versus aspirin 100 mg o.d. in patients undergoing a carotid endarterectomy on the expression of atherosclerosis markers in carotid plaque removed during endarterectomy.;Secondary Objective: - To assess the effects of S 18886 on morphology of the carotid plaque, on blood atherosclerosis markers, - To assess the cerebral vasoreactivity in this population.;Primary end point(s): Expression of biochemical markers of inflammation in carotid plaque, removed during endarterectomy.

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Countries

France

Outcome results

None listed

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