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

Phase 4CompletedNCT00812032

Karolinska Institutet25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

AspirinDRUG

75 mg per day versus 75 mg twice daily and 320mg once daily

aspirinDRUG

crossover study with three dosages: 75 mg once daily, 75 mg twice daily, 320 mg once daily.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Medicine, Clinical pharmacology Unit, Karolinska University Hospital, Solna.

Stockholm, Sweden

Outcomes

Primary Outcomes

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)

Time frame: 12 or 24 hours after last dose of Aspirin

Secondary Outcomes

Indirectly COX-related platelet aggregation induced by collagen or ADP, and thromboxane metabolite excretion.

Time frame: 12 or 24 hours after last dose of aspirin

Data from ClinicalTrials.gov

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