EUCTR2007-003186-40-SE
Active, not recruiting
Phase 1
Evaluation of antiplatelet effects of different dosages of aspirin in type 2 diabetic patients.
Karolinska Institute0 sites30 target enrollmentJuly 6, 2007
DrugsTrombyl
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with type 2 diabetes mellitus with an indication for aspirin treatment or already on aspirin treatment.
- Sponsor
- Karolinska Institute
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Type 2 DM with micro or macro\-angiopathy.
- •2\) Patients with need for aspirin treatment or already on aspirin treatment.
- •2\) Age 50\-75 years
- •3\) HbA1C 6\-9 %
- •3\) Equal number of males and females
- •4\) Antecubital forearm veins allowing technically good sampling for platelet studies.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
Exclusion Criteria
- •1\) Diet controlled DM.
- •2\) Acute or chronic kidney disease
- •3\) Acute or chronic liver disease
- •4\) Need for treatment with anticoagulants, clopidogrel, NSAID’s, or thiazolidinediones.
- •5\) Thrombocytopenia (platelet count \<150 x 109/L)
- •6\) Anticipated need for alteration of concomitant drug therapy during the course of the study.
- •7\) Enrolment in another clinical study.
- •8\) Contraindication(s) to aspirin treatment.
- •9\) A history of gastric or duodenal peptic ulcer disease.
- •10\) Acute ischemic stroke, acute coronary syndrome or revascularization procedure in the past 6 months.
Outcomes
Primary Outcomes
Not specified
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