A 52 week double blind randomised controlled trial comparing the effect of rosiglitazone versus placebo on the prevention of progression of atherosclerosis in high risk patients without diabetes

eiden University Medical Centre (LUMC) (Netherlands)0 个研究点目标入组 116 人开始时间: 2005年12月20日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•2. Age: males greater than or equal to 50 years
•3. Visceral obesity as determined by Wcr: males: greater than 94 cm
•4. Two other metabolic syndrome criteria (According to IDF criteria 2005) and/or a positive family history for cardiovascular disease (coronary heart disease [CHD] and/or peripheral arterial disease [PAD] in first degree family member: males less than 55 years; females less than 60 years)
•5. CRP greater than 1.8 mg/L
•6. Subject who is willing and is able to provide a signed and dated written informed consent

•1. Severe obesity (body mass index [BMI] greater than 35 kg/m^2)
•2. Diabetes type 2 defined as fasting venous plasma glucose greater than 70 mmol/L, or HbA1c greater than 65%
•3. Primary dyslipidaemia
•4. A previous cardiovascular event, including Q-wave infarction on electrocardiography (ECG)
•5. QTc time interval on baseline ECG greater than 450 ms
•6. Heart failure New York Heart Association (NYHA) class I or higher
•7. Hypoglycaemia
•8. Presence of clinically significant hepatic disease (i.e., subjects with alanine aminotransferase [ALT], total bilirubin, or alkaline phosphatase greater than 25 times the upper limit of the normal laboratory range)
•9. Subjects with creatinine clearance less than 40 mL/min calculated using the Cockcroft-Gault equation adjusted for ideal body weight
•10. Contraindication for magnetic resonance imaging (MRI)-assessments
•11. Risk of non-compliance

发起方

eiden University Medical Centre (LUMC) (Netherlands)