EUCTR2005-002942-20-AT进行中（未招募）不适用
Randomized, multinational, multicenter, double-blind, placebo-controlled, two-armparallel group trial of rimonabant 20 mg OD for reducing the risk of majorcardiovascular 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: 2005年12月6日最近更新:
适应症
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 88 cm (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):
- •Characteristic ischemic chest pain or pain in associated referral areas or
- •anginal equivalent symptoms,
- •Elevation of CK (at least twice the upper limit 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 above the upper limit of normal for the laboratory),
- •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 2 mm 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 evidenced 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):
- •o Fasting triglyceride level equal to or greater than 150 mg/dL (1.69 mmol/L)
- •o HDL-cholesterol less than 40 mg/dL (1.03 mmol/L) for males or less than 50 mg/dL (1.28 mmol/L) for females
- •o Fasting plasma glucose equal to or greater than 110 mg/dL (6.1 mmol/L)
- •o Blood pressure equal to or greater than 130 mm Hg systolic and/or 85 mm Hg diastolic at baseline visit
- •g) Cerebrovascular disease (at least one of the following three criteria
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 (eg, 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 or 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 one month after randomization
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