Randomized, multinational, multicenter, double-blind, placebo-controlled, two-arm parallel group trial of rimonabant 20 mg OD for reducing the risk of major cardiovascular events in abdominally obese patients with clustering risk factors - CRESCENDO
- Conditions
- Patients with abdominal obesity at increased risk for cardiovascular events (myocardial infarction, stroke and cardiovascular death)MedDRA version: 9.1Level: LLTClassification code 10003601Term: Atherosclerosis
- Registration Number
- EUCTR2005-002942-20-IT
- Lead Sponsor
- Sanofi-Synthelabo Recherche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 17000
1.Written informed consent obtained; 2. Men and women aged 55 or older; 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; 4. Presence of at least one coronary heart disease (CHD) risk equivalent OR two major cardiovascular risk factors Coronary heart disease risk equivalents (see par. 7.2 in the protocol): a) Recent (within the past 3 years)documented myocardial infarction (MI), b)Stable angina with documented multivessel coronary disease and/or history of multivessel percutaneous coronary intervention (PCI) or multivessel coronary artery bypass graft (CABG, c) Recent (within the past 3 years) cerebrovascular disease, as evidenced by an ischemic cerebrovascular episode, d)Documented symptomatic peripheral arterial disease (PAD), e)type 2 diabetes mellitus, 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 must be satisfied): - Asymptomatic disease of the carotid, intracranial, and/or vertebral arteries, with greater than 50% stenosis - At least one carotid plaque on ultrasonography, defined as a distinct area with an intima-media thickness (IMT) exceeding twice that of neighboring sites, OR Prior cerebrovascular revascularization procedure h) Renal artery disease, with greater than 60% stenosis on MR angiography, CT angiography, or angiography, or prior revascularization procedure i) Previous history of abdominal aortic aneurysm repair j) Asymptomatic ankle-brachial index less than 0.85 k) Elevated hs-CRP greater than 3 mg/L l) Males 65 years or older or females 70 years or older
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
1. Obesity due to known endocrine disorder, such as hypothyroidism, or hypopituitary or other endocrine disease 2. Pregnant or breast-feeding women 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 or presence of any severe medical or psychological condition that, in the opinion of the Investigator, would compromise the patient?s safe participation 5- Clinically significant cardiovascular disease that, in the opinion of the investigator, is likely to require intervention invasive ( within the next one month after randomization)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the efficacy of rimonabant versus placebo for reducing the risk of myocardial infarction, stroke, or cardiovascular death in patients with abdominal obesity at increased risk for such events;Secondary Objective: To demonstrate the efficacy of rimonabant versus placebo for reducing the risk of myocardial infarction, stroke, cardiovascular death, or hospitalization for cardiovascular cause (unstable angina, transient ischemic attack, cardiac rhythm disorder, congestive heart failure, syncope, or urgent revascularization procedure), in patients with abdominal obesity at increased risk for such events;Primary end point(s): The first occurrence of any component of the following cluster, as adjudicated by the Clinical Events Committee: Any MI (nonfatal or fatal) Any stroke (nonfatal or fatal) Cardiovascular death
- Secondary Outcome Measures
Name Time Method