Effect of Aggrenox® / Asasantin® Retard compared with Clopidogrel on Endothelial function as measured by Microalbuminuria, Inflammatory markers CRP, MCP-1, and MMP-9 in Patients with Type 2 Diabetes Mellitus and a history of TIA or stroke. - Aggrenox in Diabetic patients study

Conditions: Patients with Type 2 Diabetes Mellitus and a history of TIA or stroke.
MedDRA version: 9.1Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependent
MedDRA version: 9.1Level: LLTClassification code 10023027Term: Ischaemic stroke NOS
MedDRA version: 9.1Level: LLTClassification code 10044391Term: Transient ischemic attacks

Registration Number: EUCTR2006-006971-19-NO

Lead Sponsor: Aker universitetssykehus

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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 < 130/85 mmHg (with or without antihypertensive therapy)

E.Signed informed consent

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 < 100,000

D.History of bleeding disorder

E.Hct < 30, liver impairment defined as ALT/AST > 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