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

NCT00812032 | Completed Phase 4

• 1 other identifier: EudraCT No: 2007-003186-40
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

NIDDM; Aspirin; platelet inhibition; Aspirin treatment

Outcome Measures

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)

  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.

  12 or 24 hours after last dose of aspirin

Interventions

aspirin DRUG

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

Also known as: Trombyl

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

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

Stockholm, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Paul Hjemdahl, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 19, 2008
• Study Start: January 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

SE (1)