Patients with Type 2 Diabetes Mellitus and a history of TIA or stroke. MedDRA version: 9.1 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent MedDRA version: 9.1 Level: LLT Classification code 10023027 Term: Ischaemic stroke NOS MedDRA version: 9.1 Level: LLT Classification code 10044391 Term: Transient ischemic attacks
Conditions
Interventions
Trade Name: Asasantin Retard
Pharmaceutical Form: Prolonged-release capsule*
Trade Name: Plavix
Pharmaceutical Form: Tablet
Sponsors
Aker universitetssykehus
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A. Documented diabetic nephropathy with microalbuminuria (Defined by an albumin-creatinine-ratio of 3–30, measured in a sample of spot-urine). B. History of TIA or stroke C. Adults over 21 years old D. Blood-pressure =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A. Overt nephropathy (defined by an albumin-creatinine-ratio of >30, measured in a sample of spot-urine) or creatinine ? 250mmol/L. B. Thrombolytic therapy or GP IIb/IIIa inhibitor within 30 days of enrollment C. Platelet count 3 times ULN. F. History of GI bleeding, hematochezia, or melena within 30 days. G. Patients currently treated with any antiplatelet agent will be required to have a 14 day washout period prior to randomization. H. Admission for acute coronary syndrome (unstable angina, MI), revascularization procedure with stent placement, or other major cardiovascular event within 30 days. I. Active participation in other investigational drug or device trial within the last 30 days. J. Allergy or intolerance to any of the study medications. K. Insulin therapy L. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the long-term effects of Asasantin Retard® versus clopidogrel on established markers of inflammation as well as microalbuminuria in patients with type 2 diabetes mellitus and a history of TIA or stroke, using the DCA-2000 Analyzer, and time course of blood levels of CRP, MCP-1, and MMP-9 by ELISA. ;Secondary Objective: ;Primary end point(s): Microalbuminuria will be assessed in three timed, over-night urine samples at each time point. Mean value of the two samples with the highest values will be taken as the albumin excretion rate. Measurements will be performed by immunoturbidometric method at Dep. of Clinical Chemistry at Aker University Hospital. In addition, the plasma levels of hsCRP, MCP-1, and MMP-9 will be determined at the Johns Hopkins Core Laboratory by ELISA. | — |
Countries
Norway
Outcome results
None listed