Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes

Study Overview
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Brief Summary
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The primary objective is to show whether rimonabant reduces the risk of a heart attack (MI), stroke, or death from an MI or stroke in patients with abdominal obesity with other cardiovascular (CV) risk factors. The secondary objective is to show whether rimonabant reduces the risk of MI, stroke, CV death, or CV hospitalization in these patients.

Detailed Description
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The estimated study duration per patient is 36 to 53 months. All patients will be followed from randomization until a common study end date, which will occur when the last patient has been followed for 33 months.

Official Title
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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

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Drug: Rimonabant
* Drug: Placebo (for Rimonabant)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Waist circumference >102 cm (40 inches) males, >88 cm (35 inches) females, with one coronary heart disease (CHD) equivalent or two major risk factors for cardiovascular disease. CHD equivalents: Recent (within 3 years)documented heart attack Documented symptomatic coronary artery disease Recent (within 3 years) ischemic cerebrovascular episode (stroke or TIA) Documented symptomatic peripheral arterial disease Major risk factors: Documented type 2 diabetes mellitus Metabolic syndrome (NCEP criteria) Asymptomatic cerebrovascular, renal, or peripheral arterial disease, or past abdominal aortic aneurysm repair Elevated high-sensitivity C-reactive protein Age > or = 65 years for males, age > or = 70 years for females Exclusion Criteria: Obesity of known endocrine origin Pregnant or breastfeeding women Very low calorie diet or weight loss surgery within past 6 months 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 Likely cardiovascular intervention within next 1 month Allergy to rimonabant or excipients, or prior participation in a rimonabant trial Receipt of investigational product within past 30 days

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rimonabant<br>Rimonabant 20 mg once daily | Drug: Rimonabant<br>* Tablet, oral administration<br>* Other names: Acomplia;|
| Placebo Comparator: Placebo<br>Placebo (for Rimonabant) once daily. | Drug: Placebo (for Rimonabant)<br>* Tablet, oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First occurrence of any of myocardial infarction, stroke or cardiovascular (CV) death |  | From randomization up to common study end date (33-50 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First occurrence of any of myocardial infarction, stroke, CV death, and CV hospitalization |  | From randomization up to common study end date (33-50 months) | 
| All-cause mortality |  | From randomization up to common study end date (33-50 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial infarction, cerebrovascular accident, obesity