STRADIVARIUS (Strategy To Reduce Atherosclerosis Development InVolving Administration of Rimonabant - the Intravascular Ultrasound Study)

Sanofi

Status and phase

Completed

Phase 3

Conditions

Coronary Atherosclerosis

Treatments

Drug: Placebo

Drug: Rimonabant (SR141716)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00124332

EFC5827

Details and patient eligibility

About

The purpose of this study is to determine if rimonabant 20 mg once daily (od) administered during 18-20 months will reduce progression of coronary atherosclerosis as assessed by intravascular ultrasound (IVUS) when administered on top of standard behavioral and pharmacological therapy given as needed, in patients with abdominal obesity associated with current smoking and/or metabolic syndrome.

Enrollment

839 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Written and signed informed consent
Indication for coronary angiography
Abdominal obesity defined by waist circumference > 88 cm in women or > 102 cm in men
At least one of the two following conditions: *a) Metabolic syndrome as defined by the presence of at least two of the following additional risk factors: 1. Triglyceride level >= 150 mg/dL (1.69 mmol/L); 2. HDL cholesterol < 40 mg/dL (1.03 mmol/L) [men] or 50 mg/dL (1.28 mmol/L) [women]; 3. Fasting glucose >= 110 mg/dL (6.1 mmol/L); 4. High blood pressure (>= 140 mmHg systolic and/or >= 90 mmHg diastolic) at Screening visit, or current treatment by anti-hypertensive medication; *b) Currently smoking (> 10 cigarettes /day) and willing to stop
Angiographic evidence of coronary heart disease as defined by at least 1 lesion in a native coronary artery that has >= 20% reduction in lumen diameter by angiographic visual estimation
Presence of at least one coronary artery complying with the definition of "target vessel" for IVUS assessment
Acceptation of the Baseline IVUS tape by the IVUS Core Laboratory

Exclusion criteria

Age < 18 years
Pregnant or breast-feeding women
History of very low-calorie diet or surgical procedures for weight loss (eg, stomach stapling, bypass) within 6 months prior to screening visit
Obesity of known endocrine origin
Uncontrolled diabetes with HBA1c >10%
Presence of any severe medical or psychological condition, that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study
Severe congestive heart failure (New York Heart Association [NYHA] Class III or IV)
Clinically significant heart disease which in the opinion of the Investigator is likely to require coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), cardiac transplantation, surgical repair and/or replacement during the course of the study
Angioplasty of a non-qualifying artery which is considered at high risk of acute complication or restenosis, during baseline catheterization
>50% reduction in lumen diameter of the left main coronary artery by visual angiographic estimation
Recent ST-elevation myocardial infarction (MI) <= 72 hours prior to randomization