NCT Number: NCT00124332
STRADIVARIUS (Strategy To Reduce Atherosclerosis Development InVolving Administration of Rimonabant - the Intravascular Ultrasound Study)
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
sanofi-aventis, Australia, Macquarie Park, Australia
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Placebo
DrugPrimary outcomes
-
change from baseline in percent atheroma volume (PAV)
Time frame: Month 18 visit
Secondary outcomes
-
change from baseline in normalized total atheroma volume (TAV)
Time frame: Month 18 visit
Sponsors and collaborators
Lead sponsor
Sanofi
Industry
Registry information
Official study 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
Important dates
- Study start
- 2005
- Primary completion
- 2007
- Study completion
- 2007
- First posted
- Jul 27, 2005
- Registry last updated
- Apr 20, 2009
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Role of Mitophagy in Myeloid Cells During Coronary Atherosclerosis.
NCT05708547
Arterial Occlusive Diseases, Arteriosclerosis
Dijon, France
View Trial DetailsBifurcation Lesion Analysis and STenting / BLAST
NCT02316782
Arterial Occlusive Diseases, Arteriosclerosis
Kansas City, Missouri, United States
View Trial DetailsMGuard Stent and Microcirculation
NCT03087175
Arterial Occlusive Diseases, Arteriosclerosis
Annecy, France
View Trial DetailsAzelnidipine Anti-Coronary Atherosclerotic Trial in Hypertensive Patients by Serial Volumetric IVUS Analysis(ALPS-J)
NCT00294567
Arterial Occlusive Diseases, Arteriosclerosis
Tokyo, Japan
View Trial Details