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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00124332
Recruitment Status : Completed
First Posted : July 27, 2005
Last Update Posted : April 20, 2009
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Atherosclerosis Drug: Rimonabant (SR141716) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 839 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Multicenter, Double-Blind, Placebo-Controlled, Two-Arm Parallel Group Trial of Rimonabant 20-mg od, for Inhibition of Atherosclerosis Progression Assessed by IVUS (IntraVascular UltraSounds), in Overweight Patients With Clustering Risk Factors
Study Start Date : January 2005
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Primary Outcome Measures :
  1. change from baseline in percent atheroma volume (PAV) [ Time Frame: Month 18 visit ]

Secondary Outcome Measures :
  1. change from baseline in normalized total atheroma volume (TAV) [ Time Frame: Month 18 visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00124332

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United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
sanofi-aventis, Australia
Macquarie Park, Australia
sanofi-aventis, Belgium
Diegem, Belgium
Sanofi-Aventis Administrative Office
Laval, Canada
sanofi-aventis, France
Paris, France
sanofi-aventis Italy
Milano, Italy
sanofi-aventis, Netherlands
Gouda, Netherlands
sanofi-aventis Poland
Warszawa, Poland
sanofi-aventis Spain
Barcelona, Spain
Sponsors and Collaborators
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Study Director: ICD CSD Sanofi
Publications of Results:
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Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00124332    
Other Study ID Numbers: EFC5827
First Posted: July 27, 2005    Key Record Dates
Last Update Posted: April 20, 2009
Last Verified: April 2009
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Anti-Obesity Agents
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs