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

Coronary Atherosclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00124332
• Other study ID #: EFC5827
• Status: Completed
• Phase: Phase 3
• First received: July 26, 2005
• Last updated: April 17, 2009
• Start date: January 2005
• Est. completion date: October 2007

Study information

• Verified date: April 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 839
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Atherosclerosis
• Myocardial Ischemia

Intervention

Drug:
• Rimonabant (SR141716)

• Placebo

Locations

Country	Name	City	State
Australia	sanofi-aventis, Australia	Macquarie Park
Belgium	sanofi-aventis, Belgium	Diegem
Canada	Sanofi-Aventis Administrative Office	Laval
France	sanofi-aventis, France	Paris
Italy	sanofi-aventis Italy	Milano
Netherlands	sanofi-aventis, Netherlands	Gouda
Poland	sanofi-aventis Poland	Warszawa
Spain	sanofi-aventis Spain	Barcelona
United States	The Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Italy,  Netherlands,  Poland,  Spain, 

References & Publications (1)

Nissen SE, Nicholls SJ, Wolski K, Rodés-Cabau J, Cannon CP, Deanfield JE, Després 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 pro — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in percent atheroma volume (PAV)		Month 18 visit
Secondary	change from baseline in normalized total atheroma volume (TAV)		Month 18 visit