Evaluation of antiplatelet effects of different dosages of aspirin in type 2 diabetic patients.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003186-40-SE

Enrollment

Registered

2007-07-06

Start date

2007-09-05

Completion date

Unknown

Last updated

2022-04-19

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

Conditions

Patients with type 2 diabetes mellitus with an indication for aspirin treatment or already on aspirin treatment.

Interventions

Trade Name: Trombyl Product Name: Trombyl Pharmaceutical Form: Tablet Trade Name: Trombyl Product Name: Trombyl Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Type 2 DM with micro or macro-angiopathy. 2) Patients with need for aspirin treatment or already on aspirin treatment. 2) Age 50-75 years 3) HbA1C 6-9 % 3) Equal number of males and females 4) Antecubital forearm veins allowing technically good sampling for platelet studies. 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: 1) Diet controlled DM. 2) Acute or chronic kidney disease 3) Acute or chronic liver disease 4) Need for treatment with anticoagulants, clopidogrel, NSAID’s, or thiazolidinediones. 5) Thrombocytopenia (platelet count <150 x 109/L) 6) Anticipated need for alteration of concomitant drug therapy during the course of the study. 7) Enrolment in another clinical study. 8) Contraindication(s) to aspirin treatment. 9) A history of gastric or duodenal peptic ulcer disease. 10) Acute ischemic stroke, acute coronary syndrome or revascularization procedure in the past 6 months.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the degree of platelet COX-1 inhibition at the end of the dosing interval with different dosing of aspirin (75 mg OD, 75 mg BID or 320 mg OD) in type 2 diabetic patients.;Secondary Objective: To elucidate whether inflammatory markers, sex or HbA1C affects the degree of platelet Cox-1 inhibition. ;Primary end point(s): This is an exploratory study with three co-primary response variables which are directly related to platelet COX-1 inhibition: arachidonic acid-induced platelet aggregation in whole blood, in PRP and in the Cone-and-Plate(let) Assay (CPA).	—

Measure

Time frame

Main Objective: To evaluate the degree of platelet COX-1 inhibition at the end of the dosing interval with different dosing of aspirin (75 mg OD, 75 mg BID or 320 mg OD) in type 2 diabetic patients.;Secondary Objective: To elucidate whether inflammatory markers, sex or HbA1C affects the degree of platelet Cox-1 inhibition. ;Primary end point(s): This is an exploratory study with three co-primary response variables which are directly related to platelet COX-1 inhibition: arachidonic acid-induced platelet aggregation in whole blood, in PRP and in the Cone-and-Plate(let) Assay (CPA).

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Countries

Sweden

Outcome results

None listed

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