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

NCT ID: NCT00812032

Last Updated: 2022-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2010-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Interventions

Aspirin

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

Intervention Type: DRUG

aspirin

crossover study with three dosages: 75 mg once daily, 75 mg twice daily, 320 mg once daily.

Intervention Type: DRUG

Other Intervention Names

Trombyl; Trombyl

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Paul Hjemdahl

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul Hjemdahl, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

EudraCT No: 2007-003186-40

Identifier Type: -

Identifier Source: org_study_id