STRADIVARIUS (Strategy To Reduce Atherosclerosis Development InVolving Administration of Rimonabant - the Intravascular Ultrasound Study)
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ClinicalTrials.gov Identifier: NCT00124332 |
Recruitment Status :
Completed
First Posted : July 27, 2005
Last Update Posted : April 20, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Atherosclerosis | Drug: Rimonabant (SR141716) Drug: Placebo | Phase 3 |
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 |

- change from baseline in percent atheroma volume (PAV) [ Time Frame: Month 18 visit ]
- change from baseline in normalized total atheroma volume (TAV) [ Time Frame: Month 18 visit ]

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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

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
United States, Ohio | |
The Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 | |
Australia | |
sanofi-aventis, Australia | |
Macquarie Park, Australia | |
Belgium | |
sanofi-aventis, Belgium | |
Diegem, Belgium | |
Canada | |
Sanofi-Aventis Administrative Office | |
Laval, Canada | |
France | |
sanofi-aventis, France | |
Paris, France | |
Italy | |
sanofi-aventis Italy | |
Milano, Italy | |
Netherlands | |
sanofi-aventis, Netherlands | |
Gouda, Netherlands | |
Poland | |
sanofi-aventis Poland | |
Warszawa, Poland | |
Spain | |
sanofi-aventis Spain | |
Barcelona, Spain |
Study Director: | ICD CSD | Sanofi |
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 |
Atherosclerosis Coronary Artery Disease Myocardial Ischemia Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Coronary Disease Heart Diseases |
Rimonabant Anti-Obesity Agents Cannabinoid Receptor Antagonists Cannabinoid Receptor Modulators Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |