EUCTR2005-002942-20-IE进行中（未招募）不适用
Randomized, multinational, multicentre, double-blind, placebo-controlled, two-arm parallel group trial of rimonabant 20mg OD for reducing the risk of major cardiovascular events in abdominally obese patients with clustering risk factors. - CRESCENDO
Sanofi-Synthelabo Recherche0 个研究点目标入组 17,000 人开始时间: 2006年1月31日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 17,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent obtained.
- •2.Men and women aged 55 or older, AND
- •3.Presence of abdominal obesity, with a waist circumference greater than 102 cm (40 inches) for males and greater than 88cm (35 inches) for females on three successive measurements at the baseline visit, AND
- •4.Presence of at least one coronary heart disease (CHD) risk equivalent OR two major cardiovascular risk factors
- •Coronary heart disease risk equivalents:
- •a. Recent (within the past 3 years) myocardial infarction (MI) ( two of the following three criteria must be satisfied):
- •i. Characteristic ischemic chest pain or pain in associated referral areas or anginal equivalent symptoms.
- •ii. Elevation of CK (at least the upper limits of normal values for that laboratory) and/ or CK-MB (at least twice the upper limit of normal values for the laboratory) and/or troponin T or I (at least the upper limit of normal for the laboratory).
- •iii. Development of Q waves in at least two adjacent ECG leads, or development of a new dominant R wave in V1.
- •b. Stable angina with documented multivessel coronary disease (defined as greater than 50% stenosis in at least two epicardial coronary arteries at angiography), and/or history of multivessel percutaneous coronary intervention (PCI) or multivessel coronary artery bypass graft (CABG) TOGETHER WITH at least one of the three following criteria:
- •· Current exercise-induced angina pectoris
- •· Positive ECG stress test (ST depression greater than 2mm with normal baseline ST segments)
- •· Reversible defect by myocardial perfusion imaging or stress-induced wall motion abnormality on stress echocardiography test
- •c.Recent (within the past 3 years) cerebrovascular disease, as evidence by an ischemic cerebrovascular episode (all criteria must be satisfied):
- •· A focal neurological deficit
- •· Without evidence of a cardio-embolic origin
- •· Without evidence of non-vascular origin on CT or MRI scan CT or MRI must have been performed to document whether there is a lesion and to rule-out non-ischemic neurological disease.
- •d. Documented symptomatic peripheral arterial disease (PAD) (One of the following primary criteria must be satisfied):
- •· current intermittent claudication (WHO criteria, eg, leg pain occurring only while walking and disappearing in less than 10 minutes on standing) of presumed atherosclerotic origin TOGETHER WITH ankle-brachial index equal to or less than 0.85
- •in either leg at rest
- •·history of intermittent claudication (WHO criteria as above) TOGETHER WITH either previous intervention by amputation, or reconstructive vascular surgery, or angioplasty in one or both legs because of atherosclerotic disease.
- •e.Type 2 diabetes mellitus (fasting plasma glucose equal to or greater than 126 mg/dL [7.0 mmol/L] on two or more occasions.
- •Major cardiovascular risk factors:
- •f. Metabolic syndrome, as diagnosed by the presence of at least 2 of the following risk factors (if 3 of the risk factors listed below are fulfilled, this is equivalent to two major risk factors and the patient is eligible):
- •· Fasting triglyceride level equal to or greater than 150mg/dL (1.69 mmol/L)
- •· HDL-cholesterol less than 40mg/dL (1.03 mmol/L) for males or less than 50mg/dL (1.28 mmol/L) for females.
- •·Fasting plasma glucose equal to or greater than 110 mg/dL (6.1 mmol/L)
- •·Blood pressure equal to or greater than 130mm Hg systolic and/or 85 mm Hg diastolic at baseline visit
- •g.Cerebrovascular disease (at least one of the following th
排除标准
- •Related to general patient characteristics
- •1.Obesity due to known endocrine disorder, such as hypothyroidism, or
- •hypopituitary or other endocrine disease.
- •2.Pregnant or breast feeding women, or women planning to become
- •pregnant or to breast feed.
- •3.Very low-calorie diet (1200 calories a day or less) or surgical procedure for
- •weight loss (e.g. stomach stapling, bypass, etc) within 6 months prior to
- •baseline visit.
- •4.Presence of any severe medical condition or advanced age such that the
- •patient is not expected to survive for the planned study follow-up period.
- •5.Presence of any severe medical of psychological condition that, in the
- •opinion of the Investigator, would compromise the patient’s safe
- •participation.
- •6.Presence of any condition (medical, psychological, social or geographical),
- •actual or anticipated, that the Investigator feels would restrict or limit the
- •patient’s successful participation for the duration of the study.
- •7.Receipt of any investigational treatment (drug or device) within 30 days
- •prior to baseline visit.
- •8.Previous participation in a rimonabant study.
- •9.Known allergy to rimonabant or excipients.
- •Related to cardiovascular condition
- •10.Clinically significant cardiovascular disease that, in the opinion of the investigator, is likely to require intervention (PCI, CABG, valve repair/replacement, heart transplantation, PTA, peripheral bypass surgery, endarterectomy, etc) within the next month after randomization.
研究者
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