Evaluation of Antiplatelet Effects of Different Dosages of Aspirin in Type 2 Diabetic Patients
Information source: Karolinska Institutet
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: Aspirin (Drug); aspirin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Karolinska Institutet Official(s) and/or principal investigator(s):
Paul Hjemdahl, MD, PhD, Principal Investigator, Affiliation: Karolinska Institute, Stockholm, Sweden
Overall contact:
Paul Hjemdahl, MD, PhD, Phone: 0046-8-51775293, Email: paul.hjemdahl@ki.se
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.
Clinical Details
Official title: Evaluation of Antiplatelet Effects of Different Dosages of Aspirin in Type 2 Diabetic Patients
Study design: Basic Science, Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacodynamics Study
Primary outcome: 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: Indirectly COX-related platelet aggregation induced by collagen or ADP, and thromboxane metabolite excretion.
Eligibility
Minimum age: 50 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Paul Hjemdahl, MD, PhD, Phone: 0046-8-51775293, Email: paul.hjemdahl@ki.se
Department of Medicine, Clinical pharmacology Unit, Karolinska University Hospital, Solna., Stockholm, Sweden; Recruiting
Paul Hjemdahl, MD, PhD, Phone: 0046-8-51775293, Email: paul.hjemdahl@ki.se
Paul Hjemdahl, MD, PhD, Principal Investigator
Additional Information
Starting date: January 2008
Last updated: December 18, 2008
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