The prevalence of type II diabetes is increasing rapidly, contributing importantly to a new "epidemic" of coronary artery disease (CAD). Atherosclerosis accounts for 65-80% of all death among diabetic patients, a rate 2-to 4-fold higher than in non-diabetics. Furthermore, diabetic patients often have silent CAD .
Conditions
Interventions
Trade Name: Sortis 40mg
Pharmaceutical Form: Tablet
INN or Proposed INN: atorvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Trade Name: Dilatrend
Pha
Sponsors
University Hospital Department of Cardiology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients qualifying for this study have to be diabetics without history or symptoms of CAD. Furthermore, type II diabetic patients have to be less than 75 years of age and at high risk for CAD defined as additional evidence of cerebral (carotid bruit) or peripheral vascular occlusive artery disease (history of claudication, absent pulse of the dorsalis pedis or posterior tibial artery, or femoral bruit on auscultation), retinopathy, evidence for autonomic dysfunction or increased urinary albumin, proteinuria, or they have to be ?55years old with a history of diabetes II ? 5 years and ?2 risk factors of CAD in addition to diabetes [modified from the American Diabetes Association guidelines, that are based on the clinical judgment of a panel of experts rather than on data])(20). In addition, informed consent has to be obtained from the patient, before enrollement into the study. 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
Exclusion criteria: Exclusion criteria are: Age above 75 years, severe illness with a life expectancy of less than 3 years and evidence for prior CAD (prior myocardial infarction, angina), and shortness of breath (NYHA IV).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: s. above;Primary end point(s): 1° clinical: Cardiac death, myocardial infarction, onset of angina, or hospitalization (for acute coronary syndrome or symptomatic need for revascularization) 1° myocardial perfusion SPECT: Evolution of ischemic burden (summed difference score [SDS]) and overall MPS abnormality (SSS). ;Main Objective: • To detect endothelial dysfunction as marker of early atherosclerotic disease and more specifically, silent CAD in asymptomatic diabetic patients at risk for CAD - in order to define the prevalence of early disease and the relation between these two markers of disease (endothelial dysfunction and silent CAD). • To define the development/progression of early disease in patients without endothelial dysfunction and/or silent CAD at baseline - over a two year time period. • To compare two treatment strategies in patients with silent CAD - medical versus revascularization therapy, in addition to risk factor management with respect to two year follow-up. | — |
Countries
Germany
Outcome results
None listed