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

This study has been completed.
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00812032
First received: December 18, 2008
Last updated: July 30, 2010
Last verified: December 2009
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Drug: Aspirin
Drug: aspirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Evaluation of Antiplatelet Effects of Different Dosages of Aspirin in Type 2 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: January 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: December 18, 2008
Last Updated: July 30, 2010
Health Authority: Sweden: Medical Products Agency

Keywords provided by Karolinska Institutet:
NIDDM
Aspirin
platelet inhibition
Aspirin treatment

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Aspirin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014