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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00124332
First received: July 26, 2005
Last updated: April 17, 2009
Last verified: April 2009
  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 (SR141716)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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

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

Enrollment: 839
Study Start Date: January 2005
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

Publications:
Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00124332     History of Changes
Other Study ID Numbers: EFC5827
Study First Received: July 26, 2005
Last Updated: April 17, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Rimonabant
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014