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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00124332




Registration number
NCT00124332
Ethics application status
Date submitted
26/07/2005
Date registered
27/07/2005
Date last updated
20/04/2009

Titles & IDs
Public title
STRADIVARIUS (Strategy To Reduce Atherosclerosis Development InVolving Administration of Rimonabant - the Intravascular Ultrasound Study)
Scientific 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
Secondary ID [1] 0 0
EFC5827
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Atherosclerosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rimonabant (SR141716)
Treatment: Drugs - Placebo

Treatment: Drugs: Rimonabant (SR141716)


Treatment: Drugs: Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
change from baseline in percent atheroma volume (PAV)
Timepoint [1] 0 0
Month 18 visit
Secondary outcome [1] 0 0
change from baseline in normalized total atheroma volume (TAV)
Timepoint [1] 0 0
Month 18 visit

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2007
Sample size
Target
Accrual to date
Final
839
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
sanofi-aventis, Australia - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Ohio
Country [2] 0 0
Belgium
State/province [2] 0 0
Diegem
Country [3] 0 0
Canada
State/province [3] 0 0
Laval
Country [4] 0 0
France
State/province [4] 0 0
Paris
Country [5] 0 0
Italy
State/province [5] 0 0
Milano
Country [6] 0 0
Netherlands
State/province [6] 0 0
Gouda
Country [7] 0 0
Poland
State/province [7] 0 0
Warszawa
Country [8] 0 0
Spain
State/province [8] 0 0
Barcelona

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00124332
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00124332