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Evaluation of Antiplatelet Effects of Different Dosages of Aspirin in Type 2 Diabetic Patients (DM-ASA 001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00812032
Recruitment Status : Completed
First Posted : December 19, 2008
Last Update Posted : August 2, 2010
Information provided by:
Karolinska Institutet

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Aspirin Drug: aspirin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of Antiplatelet Effects of Different Dosages of Aspirin in Type 2 Diabetic Patients
Study Start Date : January 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Intervention Details:
  • Drug: Aspirin
    75 mg per day versus 75 mg twice daily and 320mg once daily
    Other Name: Trombyl
  • Drug: aspirin
    crossover study with three dosages: 75 mg once daily, 75 mg twice daily, 320 mg once daily.
    Other Name: Trombyl

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00812032

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Department of Medicine, Clinical pharmacology Unit, Karolinska University Hospital, Solna.
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
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Principal Investigator: Paul Hjemdahl, MD, PhD Karolinska Institutet
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Responsible Party: Prof. Paul Hjemdahl, Dept Medicine Solna, Clinical Pharmacology Unit, Karolinska Institute, Stockholm, Sweden Identifier: NCT00812032    
Other Study ID Numbers: EudraCT No: 2007-003186-40
First Posted: December 19, 2008    Key Record Dates
Last Update Posted: August 2, 2010
Last Verified: December 2009
Keywords provided by Karolinska Institutet:
platelet inhibition
Aspirin treatment
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors