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Completed

NCT Number: NCT00812032

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aspirin

Drug

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

Other names: Trombyl

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Acronym: DM-ASA 001

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 19, 2008
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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