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

This study has been completed.

Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00124332
  Purpose

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 Intervention Phase
Coronary Atherosclerosis
Drug: Rimonabant
Phase III

Genetics Home Reference related topics:   Coronary Artery Disease  

MedlinePlus related topics:   Ultrasound  

ChemIDplus related topics:   Rimonabant   SR 141716A  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy 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

Further study details as provided by Sanofi-Aventis:

Estimated Enrollment:   800
Study Start Date:   January 2005
Estimated Study Completion Date:   August 2007

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124332

Locations
United States, Ohio
The Cleveland Clinic Foundation    
      Cleveland, Ohio, United States, 44195

Sponsors and Collaborators
Sanofi-Aventis
  More Information

Publications indexed to this study:

Study ID Numbers:   EFC5827, SR141716
First Received:   July 26, 2005
Last Updated:   November 26, 2007
ClinicalTrials.gov Identifier:   NCT00124332
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Coronary Disease
Arterial Occlusive Diseases
Atherosclerosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Disease Progression
Overweight
Ischemia
Arteriosclerosis
Coronary Artery Disease

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 03, 2008




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