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

Primary Purpose

Coronary Atherosclerosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rimonabant (SR141716)
Placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Atherosclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Cleveland Clinic Foundation
  • sanofi-aventis, Australia
  • sanofi-aventis, Belgium
  • Sanofi-Aventis Administrative Office
  • sanofi-aventis, France
  • sanofi-aventis Italy
  • sanofi-aventis, Netherlands
  • sanofi-aventis Poland
  • sanofi-aventis Spain

Outcomes

Primary Outcome Measures

change from baseline in percent atheroma volume (PAV)

Secondary Outcome Measures

change from baseline in normalized total atheroma volume (TAV)

Full Information

First Posted
July 26, 2005
Last Updated
April 17, 2009
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00124332
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
839 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rimonabant (SR141716)
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
change from baseline in percent atheroma volume (PAV)
Time Frame
Month 18 visit
Secondary Outcome Measure Information:
Title
change from baseline in normalized total atheroma volume (TAV)
Time Frame
Month 18 visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
sanofi-aventis, Australia
City
Macquarie Park
Country
Australia
Facility Name
sanofi-aventis, Belgium
City
Diegem
Country
Belgium
Facility Name
Sanofi-Aventis Administrative Office
City
Laval
Country
Canada
Facility Name
sanofi-aventis, France
City
Paris
Country
France
Facility Name
sanofi-aventis Italy
City
Milano
Country
Italy
Facility Name
sanofi-aventis, Netherlands
City
Gouda
Country
Netherlands
Facility Name
sanofi-aventis Poland
City
Warszawa
Country
Poland
Facility Name
sanofi-aventis Spain
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
18387931
Citation
Nissen SE, Nicholls SJ, Wolski K, Rodes-Cabau J, Cannon CP, Deanfield JE, Despres 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 progression of atherosclerosis in patients with abdominal obesity and coronary artery disease: the STRADIVARIUS randomized controlled trial. JAMA. 2008 Apr 2;299(13):1547-60. doi: 10.1001/jama.299.13.1547. Epub 2008 Apr 1.
Results Reference
result

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

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