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Effects of S 18886 on platelet function in type 2 diabetic patients treated by low-dose aspirin and with elevated levels of thromboxane A2. A multicentre, randomised, double-blind, cross-over study comparing S 18886 30 mg o.d. versus aspirin 100 mg o.d. administered orally. - ND

Effects of S 18886 on platelet function in type 2 diabetic patients treated by low-dose aspirin and with elevated levels of thromboxane A2. A multicentre, randomised, double-blind, cross-over study comparing S 18886 30 mg o.d. versus aspirin 100 mg o.d. administered orally. - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-005262-31-IT
Enrollment
Unknown
Registered
2008-11-19
Start date
2008-12-02
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Ischaemic stroke MedDRA version: 9.1 Level: PT Classification code 10043647 Term: Thrombotic stroke

Interventions

Product Name: S18886 Product Code: S18886 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Terutroban CAS Number: 165538-40-9 Current Sponsor code: S18886 Concentration unit: mg milligram(

Sponsors

INSTITUT DE RECHERCHES INTERNATIONALES SERVIER
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Type 2 diabetes mellitus for at least three months - Age between 50 and 75 years old inclusive - Men or post-menopausal women (or with no possibility of becoming pregnant during the study) - Daily treatment by low-dose aspirin for primary or secondary prevention of cardiovascular diseases 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: - Platelet count 500 G/L - Poorly controlled diabetes - Personal history of coagulation disorder, thrombocytopathy, spontaneous bleeding or family genetic disorder of coagulation - Gastric pain or active peptic ulcer disease < 6 months - Repeated minor bleedings - Any history of haemorrhagic stroke or stroke of unknown origin - Suspected aortic dissection - Major surgery or major trauma < 6 months

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the short-term effects of S 18886, compared to low-dose aspirin, on platelet function in type 2 diabetic patients.;Secondary Objective: To determine the effects of S 18886 on inflammation or platelet activation biomarkers detected in plasma and urine.;Primary end point(s): Percentage of platelet aggregation.—

Countries

Italy

Outcome results

None listed

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