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

Phase 1

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

• Registration Number: EUCTR2007-003186-40-SE
• Lead Sponsor: Karolinska Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-07-06
• Study Completion: 2010-10-06
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>;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).