Status:
COMPLETED
Evaluation of Antiplatelet Effects of Different Dosages of Aspirin in Type 2 Diabetic Patients
Lead Sponsor:
Karolinska Institutet
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
50-75 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00812032
Start Date
January 1 2008
End Date
October 1 2010
Last Update
May 27 2022
Active Locations (1)
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1
Department of Medicine, Clinical pharmacology Unit, Karolinska University Hospital, Solna.
Stockholm, Sweden