Tiral of Invasive versus Medical therapy of Early coronary artery disease in Diabetes (TIME-DM)

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2007
INTERVENTION: 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 Pharmaceutical Form: Tablet INN or Proposed INN: carvedilol Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2x25‐ Trade Name: Aspirin 100mg, Product Name: Aspirin N 100mg Pharmaceutical Form: Tablet INN or Proposed INN: aspirin Concentration unit: mg milligram(s) Concentration type: equal CONDITION: 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 . PRIMARY OUTCOME: 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.; 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). ; Secondary Objective: s. above 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 ra
Epistemonikos ID: dcd1b8583f6bdfd5cf33db52a95274cbd0594872
First added on: Jul 27, 2021