STRADIVARIUS (Strategy To Reduce Atherosclerosis Development InVolving Administration of Rimonabant - the Intravascular Ultrasound Study)
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
1 other identifier
interventional
839
9 countries
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2005
Typical duration for phase_3
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 26, 2005
CompletedFirst Posted
Study publicly available on registry
July 27, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedApril 20, 2009
April 1, 2009
2.7 years
July 26, 2005
April 17, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
change from baseline in percent atheroma volume (PAV)
Month 18 visit
Secondary Outcomes (1)
change from baseline in normalized total atheroma volume (TAV)
Month 18 visit
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (9)
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
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
Milan, Italy
sanofi-aventis, Netherlands
Gouda, Netherlands
sanofi-aventis Poland
Warsaw, Poland
sanofi-aventis Spain
Barcelona, Spain
Related Publications (1)
Nissen SE, Nicholls SJ, Wolski K, Rodes-Cabau J, Cannon CP, Deanfield JE, Despres JP, Kastelein JJ, Steinhubl SR, Kapadia S, Yasin M, Ruzyllo W, Gaudin C, Job B, Hu B, Bhatt DL, Lincoff AM, Tuzcu EM; STRADIVARIUS Investigators. Effect of rimonabant on progression of atherosclerosis in patients with abdominal obesity and coronary artery disease: the STRADIVARIUS randomized controlled trial. JAMA. 2008 Apr 2;299(13):1547-60. doi: 10.1001/jama.299.13.1547. Epub 2008 Apr 1.
PMID: 18387931RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ICD CSD
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 26, 2005
First Posted
July 27, 2005
Study Start
January 1, 2005
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
April 20, 2009
Record last verified: 2009-04