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

This study has been completed.
Study NCT00124332.   Last updated on July 7, 2008.   Information provided by Sanofi-Aventis

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Descriptive Information Fields
Brief Title  STRADIVARIUS (Strategy To Reduce Atherosclerosis Development InVolving Administration of Rimonabant - the Intravascular Ultrasound Study)
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
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.

Detailed Description
Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  change from baseline in percent atheroma volume (PAV) [ Time Frame: Month 18 visit ]
Secondary Outcome Measure  change from baseline in normalized total atheroma volume (TAV) [ Time Frame: Month 18 visit ]
Condition  Coronary Atherosclerosis
Intervention  Drug: Rimonabant (SR141716)
Drug: Placebo
MEDLINE PMIDs 18387931
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  839
Start Date  January 2005
Completion Date October 2007
Eligibility Criteria 

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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States,   Australia,   Belgium,   Canada,   France,   Italy,   Netherlands,   Poland,   Spain
Administrative Information Fields
NCT ID  NCT00124332
Organization ID EFC5827
Secondary IDs †† SR141716
Study Sponsor  Sanofi-Aventis
Collaborators ††
Investigators 
Study Director:     ICD CSD     Sanofi-Aventis    
Information Provided By Sanofi-Aventis
Verification Date July 2008
First Received Date  July 26, 2005
Last Updated Date July 7, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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