A double blind placebo controlled study on the effect of cerivastatin on the process of atherosclerosis in non-insulin dependent diabetes mellitus.|
|- candidate number||1483|
|- NTR Number||NTR288|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||9-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||A double blind placebo controlled study on the effect of cerivastatin on the process of atherosclerosis in non-insulin dependent diabetes mellitus.|
|- Scientific Title||A double blind placebo controlled study on the effect of cerivastatin on the process of atherosclerosis in non-insulin dependent diabetes mellitus.|
|- ACRONYM||CERDIA study|
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 2 (DM type II)|
|- Inclusion criteria||1. Patient with Non-Insulin Dependent Diabetes Mellitus. The diagnosis based upon the age of onset, the presence of obesity and the absence of ketoacidosis at the time of diagnosis and the use of diet or oral anti-diabetic drugs for more than one year from diagnosis;|
2. Males and females;
3. Age range: 30 - 80 years;
4. Given written informed consent.
|- Exclusion criteria||1. Angina pectoris;|
2. History of myocardial infarction, PTCA or CABG;
3. Positive ECG criteria for a myocardial infarction in the past;
4. History of ischemic CVA;
5. Peripheral artery by-pass surgery or amputation because of atherosclerotic disease or claudication;
6. Secondary diabetes (steroid induced, Cushing, haemochromatosis, alcohol abuse, pancreatitis);
7. Untreated or uncontrolled hyperthyroidism or hypothyroidism;
8. Active liver disease (hepatitis, cirrhosis or biliary obstruction) or hepatic dysfunction (repeated aminotransferase-values more than 150% of the upper limit of normal (ULN);
9. Impaired renal function with creatinine clearance < 30 ml/min;
10. Baseline CK values $ 3 x ULN;
11. Fasting total cholesterol above 6.9 mmol/l despite diet or below 4.0 mmol/l or triglycerides above 6.0 mmol/l;
12. Any hereditary dyslipidemia;
13. Known allergy to HMG-coA-reductase inhibitors;
14. Pregnancy or lactation;
15. Women of childbearing potential, not using adequate contraceptives;
16. Use of lipid lowering medication, within eight weeks before the start of the study;
17. Life expectancy of less than two years;
18. Any other condition that in the opinion of the investigator could lead to inappropriate absorption, metabolism or elimination of the medication or compromise the patients= safety, or lead to insufficient compliance with the study drug regimen.
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-aug-1999|
|- planned closingdate||31-mrt-2003|
|- Target number of participants||250|
|- Interventions||1. Patients of the intervention group will be treated with cerivastatin 0.4mg/day for two years; |
2. Controls will get placebo. In August 2001, when cerivastatin was withdrawn from the market, 0.4 mg cerivastatin was replaced by 20 mg simvastatin without deblinding the study.
|- Primary outcome||The change of IMT and distensibility after 24 months using B-mode ultrasound at the carotid artery level.|
|- Secondary outcome||1. The change in the prevalence of (silent) myocardial ischemia after 24 months as monitored with 48h-ambulatory ECG;|
2. The change of endothelium function after 24 months using flow mediated vasodilation assessed by ultrasound of the a. brachialis;
3. The change in blood levels of parameters for endothelial function, haemostasis, fibrinolysis, platelet activation, endothelial cell injury and vascular wall inflammation;
4. Biochemical endpoints: total cholesterol, HDL-cholesterol, (calculated) LDL-cholesterol, triglycerides, LDL/ApoB100 ratio, LpA-I, Lp(a);
5. Diabetic nephropathy: Creatinine clearance and microalbuminuria;
6. Clinical endpoints of cardiovascular disease.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MD. PhD. M.V. Huisman|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. M.V. Huisman|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC), Department of Cardiology, Leiden University Medical Center (LUMC), Department of General Internal Medicine|
(Source(s) of Monetary or Material Support)
|- Publications||-Beishuizen ED, van de Ree MA, Jukema JW, Tamsma JT, van der Vijver JC, Meinders AE, Putter H, Huisman MV. Diabetes Care 2004;27:2887-92.|
-Beishuizen ED, Tamsma JT, Jukema JW, van de Ree MA, van der Vijver JC, Meinders AE, Huisman MV. Diabetes Care 2005;28:1668-74.
-Beishuizen ED, Jukema JW, Tamsma JT, van de Ree MA, van der Vijver JC, Putter H, Maan AC, Meinders AE, Huisman MV. Diabetes Care 2005;28:1675-9.
|- Brief summary||Objective: |
Cardiovascular disease (CVD) is the most important cause of mortality in patients with type 2 diabetes.
We aimed to determine the effect of statin therapy versus placebo on the progression of carotid intima-media thickness (IMT) in type 2 diabetic patients without manifest CVD.
Research design and methods:
A randomized, placebo-controlled, double-blind clinical trial was performed in 250 patients with type 2 diabetes.
Patients were given either 0.4 mg cerivastatin or placebo daily. In August 2001, when cerivastatin was withdrawn from the market, 0.4 mg cerivastatin was replaced by 20 mg simvastatin without deblinding the study.
The primary end point:
The change of mean common carotid IMT, as measured by B-mode ultrasound, over 2 years.
|- Main changes (audit trail)|
|- RECORD||9-sep-2005 - 4-jun-2008|
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