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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Aspirin
aspirin
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring NIDDM, Aspirin, platelet inhibition, Aspirin treatment

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Outcomes

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)

Secondary Outcome Measures

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

Full Information

First Posted
December 18, 2008
Last Updated
May 24, 2022
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT00812032
Brief Title
Evaluation of Antiplatelet Effects of Different Dosages of Aspirin in Type 2 Diabetic Patients
Acronym
DM-ASA 001
Official Title
Evaluation of Antiplatelet Effects of Different Dosages of Aspirin in Type 2 Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
NIDDM, Aspirin, platelet inhibition, Aspirin treatment

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
Trombyl
Intervention Description
75 mg per day versus 75 mg twice daily and 320mg once daily
Intervention Type
Drug
Intervention Name(s)
aspirin
Other Intervention Name(s)
Trombyl
Intervention Description
crossover study with three dosages: 75 mg once daily, 75 mg twice daily, 320 mg once daily.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Hjemdahl, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, Clinical pharmacology Unit, Karolinska University Hospital, Solna.
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

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

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