EUCTR2005-002942-20-DE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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20,300
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,
- •Major cardiovascular risk factors:
- •e) Type 2 diabetes mellitus (fasting plasma or serum glucose equal to or greater than
- •126 mg/dL [7.0 mmol/L] on two or more occasions)
- •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 or serum 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 follo
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 including uncontrolled serious psychiatric illness such as major depression, suicidal ideation, and medical history of suicide attempt.
- •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
研究者
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