Evaluation of Antiplatelet Effects of Different Dosages of Aspirin in Type 2 Diabetic Patients

Study Overview
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Brief Summary
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The efficacy of low dose aspirin appears to be substantially lower in diabetic patients, compared to patients without diabetes. The aim of the investigators study is to test the laboratory response to different dosing of aspirin in type 2 Diabetes Mellitus. The investigators will compare the regular dose of 75mg once daily to 75 mg twice daily or to 320 mg once daily. The hypothesis of the study is that twice daily dosing of aspirin may improve the response to aspirin.

Official Title
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Evaluation of Antiplatelet Effects of Different Dosages of Aspirin in Type 2 Diabetic Patients

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Aspirin
* Drug: aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 DM with micro- or macroangiopathy. HbA1c 6-9 % (Mono-S method). Need for, or already on-going aspirin treatment. Age 50-75 years Antecubital forearm veins allowing technically good sampling for platelet studies Exclusion Criteria: Diet controlled DM. Acute ischemic stroke, acute coronary syndrome, (myocardial infarction or unstable angina pectoris), or revascularization by PCI or by-pass surgery within the last 6 months. Acute or chronic kidney disease (P-cystatin C within the reference interval) Acute or chronic liver disease (ALAT ≤2 times the upper reference value). A history of gastric or duodenal ulcer disease. Need for treatment with anticoagulants, clopidogrel, NSAID's, or thiazolidinediones. Thrombocytopenia (platelet count <150 x 109/L) Anticipated need for alteration of concomitant drug therapy during the course of the study. Enrollment in another clinical study. Contraindication(s) to aspirin treatment.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aspirin|75 mg per day versus 75 mg twice daily and 320mg once daily|
|Drug: aspirin|crossover study with three dosages: 75 mg once daily, 75 mg twice daily, 320 mg once daily.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 and PRP and in the Cone-and-Plate(let) Assay (CPA) |  | 12 or 24 hours after last dose of Aspirin | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indirectly COX-related platelet aggregation induced by collagen or ADP, and thromboxane metabolite excretion. |  | 12 or 24 hours after last dose of aspirin | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NIDDM, Aspirin, platelet inhibition, Aspirin treatment