Randomized, multicenter, double-blind, placebo-controlled, two-arm parallel group trial of rimonabant 20-mg od, for inhibition of astherosclerosis progression assessed by IVUS (IntraVascular UltraSounds), in overweight patients with clustering risk factors. - STRADIVARIUS

Sanofi-Synthelabo-Recherche0 个研究点目标入组 800 人开始时间: 2005年11月3日最近更新: 2021年9月7日

适应症

试验速览

暂无简介。

•1.Written and signed informed consent
•2.Indication for coronary angiography
•3.Abdominal obesity defined by waist circumference > 88 cm in women or > 102 cm in men
•4.At least one of the two following conditions:
•->Metabolic syndrome as defined by the presence of at least two of the following additional risk factors:
•- Triglyceride level = 150 mg/dL (1.69 mmol/L)
•- HDL cholesterol < 40 mg/dL (1.03 mmol/L) [men] or 50 mg/dL (1.28 mmol/L) [women]
•- Fasting glucose = 110 mg/dL (6.1 mmol/L)
•- High blood pressure (= 140 mmHg systolic and/or = 90 mmHg diastolic) at Screening
•visit, or current treatment by anti-hypertensive medication
•->Currently smoking (> 10 cigarettes /day) and willing to stop
•5.Angiographic evidence of coronary heart disease as defined by at least 1 lesion in a native coronary artery that has 20% reduction in lumen diameter by angiographic visual estimation
•6.Presence of at least one coronary artery complying with the definition of target vessel” for IVUS assessment (see full definition in the inclusion criteria section)
•7.Acceptation of the Baseline IVUS tape by the IVUS Core Laboratory
•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

•- Age < 18 years
•- Pregnant or breast-feeding women
•- History of very low-calorie diet or surgical procedures for weight loss (eg, stomach stapling, bypass) within 6 months prior to screening visit
•- Obesity of known endocrine origin
•- Uncontrolled diabetes with HBA1c >10%
•- Presence of any severe medical or psychological condition, that in the opinion of the Investigator would compromise the subject’s safety or successful participation in the study
•- Severe congestive heart failure (NYHA Class III or IV)
•- Clinically significant heart disease which in the opinion of the Investigator is likely to require CABG, PCI, cardiac transplantation, surgical repair and/or replacement during the course of the study
•- Angioplasty of a nonqualifying artery which is considered at high risk of acute complication or restenosis, during baseline catheterization
•- Recent ST-elevation MI=72 hours prior to randomization
•- >50% reduction in lumen diameter of the Left Main Coronary Artery by visual angiographic estimation

发起方

Sanofi-Synthelabo-Recherche