NCT00124332已完成3 期
Randomized, Multicenter, Double-Blind, Placebo-Controlled, Two-Arm Parallel Group Trial of Rimonabant 20-mg od, for Inhibition of Atherosclerosis Progression Assessed by IVUS (IntraVascular UltraSounds), in Overweight Patients With Clustering Risk Factors
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 839
- 试验地点
- 9
- 主要终点
- change from baseline in percent atheroma volume (PAV)
研究概览
简要总结
The purpose of this study is to determine if rimonabant 20 mg once daily (od) administered during 18-20 months will reduce progression of coronary atherosclerosis as assessed by intravascular ultrasound (IVUS) when administered on top of standard behavioral and pharmacological therapy given as needed, in patients with abdominal obesity associated with current smoking and/or metabolic syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written and signed informed consent
- •Indication for coronary angiography
- •Abdominal obesity defined by waist circumference > 88 cm in women or > 102 cm in men
- •At least one of the two following conditions: *a) 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; *b) Currently smoking (> 10 cigarettes /day) and willing to stop
- •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
- •Presence of at least one coronary artery complying with the definition of "target vessel" for IVUS assessment
- •Acceptation of the Baseline IVUS tape by the IVUS Core Laboratory
排除标准
- •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 (New York Heart Association [NYHA] Class III or IV)
- •Clinically significant heart disease which in the opinion of the Investigator is likely to require coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), cardiac transplantation, surgical repair and/or replacement during the course of the study
- •Angioplasty of a non-qualifying artery which is considered at high risk of acute complication or restenosis, during baseline catheterization
- •>50% reduction in lumen diameter of the left main coronary artery by visual angiographic estimation
- •Recent ST-elevation myocardial infarction (MI) <= 72 hours prior to randomization
结局指标
主要结局
change from baseline in percent atheroma volume (PAV)
时间窗: Month 18 visit
次要结局
- change from baseline in normalized total atheroma volume (TAV)(Month 18 visit)
研究者
研究点 (9)
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