Contact information
Type
Scientific
Primary contact
Dr Olivier Bertrand
ORCID ID
Contact details
Laval Hospital
2725 Chemin Ste Foy
Québec
G1V 4G5
Canada
+1 418 656 8711 ext 3136
olivier.bertrand@crhl.ulaval.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00169832
Protocol/serial number
49653/416
Study information
Scientific title
Acronym
VeIn-Coronary aTherOsclerosis and Rosiglitazone after bypass surgerY. The VICTORY Trial.
Study hypothesis
Hypotheses:
1. Rosiglitazone in diabetic patients with previous coronary bypass surgery may prevent or slow the progression of atherosclerosis in saphenous vein grafts (SVGs) and native coronary arteries
2. Rosiglitazone has favorable effects on adipose tissue distribution variables as well as on thrombosis, pro-inflammatory, and lipid profiles in diabetic patients after coronary bypass artery surgery
3. Rosiglitazone therapy influences favorably metabolism and clinical outcomes in diabetic patients after coronary artery bypass surgery
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Multi-centre
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Diabetes
Intervention
A multi-center randomized double-blind trial comparing rosiglitazone to placebo.
At baseline, patients undergo
1. Angiography and intravascular ultrasound examinations
2. Abdominal fat distribution (computed tomography [CT] scan) and body composition (dual energy X-ray absorptiometry [DEXA])
3. Blood tests
4. Exercise test
5. Holter monitoring
After 12 months follow-up, all tests are repeated.
Intervention type
Drug
Phase
Not Specified
Drug names
Rosiglitazone
Primary outcome measures
The primary endpoint of the study will be the change (12-month intravascular ultrasound [IVUS] Baseline IVUS) in plaque volume in a segment of at least 40 mm in one SVG as measured by IVUS.
Secondary outcome measures
IVUS:
1. The change in plaque volume from baseline to 12 month follow-up in a segment of anastomosed coronary artery of at least 20 mm
2. The changes from baseline to 12-month follow-up in lumen volume and in total vessel volume in the ≥40 mm SVG segment and in the ≥20 mm coronary segment
3. The changes from baseline to 12-month follow-up in lumen area, plaque area, and total vessel area in the ≥40 mm SVG segment and in the ≥20 mm coronary segment
4. The changes from baseline to 12-month follow-up in qualitative plaque characterization in the ≥40 mm SVG segment and in the ≥20 mm coronary segment
5. The proportion of patients showing atherosclerosis changes (progression/regression)
6. The proportion of patients showing atherosclerosis changes 'concordance', i.e. progression in SVG segment and coronary segment and atherosclerosis 'discordance', i.e. progression, stabilization or regression noted in one of the analyzed segment not found in the other analyzed segment
Angiography:
1. The proportion of patients showing new occlusions in native coronary arteries or SVGs
2. The changes in reference and minimum lumen diameters of the SVG as assessed by quantitative coronary angiography (QCA)
3. The per-patient percentage of initially patent SVGs that had significant progression of atherosclerosis at the site of greatest change at follow-up
Metabolic risk factors:
Changes from baseline to 6 and 12 months of indices for comprehensive lipid, thrombosis and pro-inflammatory profiles as well as glucose-insulin homeostasis, microalbuminuria, adhesion molecules, adipokines, and other markers relevant to the evaluation and management of cardiovascular disease risk
Body composition and distribution parameters:
1. Changes in abdominal areas and volumes of adipose tissue as well as mid-thigh areas of adipose tissue and muscle attenuations assessed by computed tomography (CT) from baseline to 6 and 12 months
2. Changes in body composition assessed by DEXA from baseline to 6 and 12 months and bioelectrical impedance analysis (BIA) from baseline to 2, 4, 6 and 12 months
3. Changes in body weight, waist circumference and body mass index (BMI) will be evaluated from baseline to 2, 4, 6, 8, 10 and 12 months
Clinical outcomes:
1. The recording of clinical laboratory parameters, physical examinations, vital signs (blood pressure and heart rate), electrocardiograms, concomitant medication, and adverse events will assess patients safety
2. Presence of any of the following: death, myocardial infarction (MI), transient ischemic attack (TIA), stroke, hospitalization, and ischemia-driven interventions (percutaneous coronary intervention [PCI]/CABG) will be recorded
3. Fluid retention will be evaluated by BIA
Overall trial start date
01/04/2003
Overall trial end date
30/06/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Stable diabetic patients (HbA1c inferior or equal to 9.0%) with previous coronary bypass surgery (1-10 years) and a suitable 40 mm segment in a vein graft and a 20 mm segment in native coronary artery.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
280
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/04/2003
Recruitment end date
30/06/2006
Locations
Countries of recruitment
Canada
Trial participating centre
Laval Hospital
Québec
G1V 4G5
Canada
Sponsor information
Organisation
Laval Hospital Research Center (Canada)
Sponsor details
2725 Chemin Ste Foy
Québec
G1V 4G5
Canada
+1 418 656 8711
olivier.betrand@crhl.ulaval.ca
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
This is an investigator-initiated-trial which is funded by an unrestricted grant from GlaxoSmithKline
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary