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

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ClinicalTrials.gov Identifier: NCT00812032
Recruitment Status : Completed
First Posted : December 19, 2008
Last Update Posted : August 2, 2010
Sponsor:
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

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
U.S. FDA Resources


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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT00812032


Locations
Sweden
Department of Medicine, Clinical pharmacology Unit, Karolinska University Hospital, Solna.
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Paul Hjemdahl, MD, PhD Karolinska Institutet

Responsible Party: Prof. Paul Hjemdahl, Dept Medicine Solna, Clinical Pharmacology Unit, Karolinska Institute, Stockholm, Sweden
ClinicalTrials.gov Identifier: NCT00812032     History of Changes
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:
NIDDM
Aspirin
platelet inhibition
Aspirin treatment

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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
Antipyretics