A Multi-center Randomized Double-Blind Trial Comparing Rosiglitazone to Placebo for the Prevention of Atherosclerosis Progression after Coronary Bypass Surgery in Diabetic Patients
| ISRCTN | ISRCTN54136716 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54136716 |
| ClinicalTrials.gov number | NCT00169832 |
| Secondary identifying numbers | 49653/416 |
- Submission date
- 29/01/2005
- Registration date
- 21/02/2005
- Last edited
- 28/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Olivier Bertrand
Scientific
Scientific
Laval Hospital
2725 Chemin Ste Foy
Québec
G1V 4G5
Canada
| Phone | +1 418 656 8711 ext 3136 |
|---|---|
| olivier.bertrand@crhl.ulaval.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Multi-centre |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | Cardiometabolic effects of rosiglitazone in patients with type 2 diabetes and coronary artery bypass grafts: A randomized placebo-controlled clinical trial |
| Study acronym | VeIn-Coronary aTherOsclerosis and Rosiglitazone after bypass surgerY. The VICTORY Trial. |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Rosiglitazone |
| Primary outcome measure | 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 study start date | 01/04/2003 |
| Completion date | 30/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 280 |
| Key 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. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/04/2003 |
| Date of final enrolment | 30/06/2006 |
Locations
Countries of recruitment
- Canada
Study participating centre
Laval Hospital
Québec
G1V 4G5
Canada
G1V 4G5
Canada
Sponsor information
Laval Hospital Research Center (Canada)
Hospital/treatment centre
Hospital/treatment centre
2725 Chemin Ste Foy
Québec
G1V 4G5
Canada
| Phone | +1 418 656 8711 |
|---|---|
| olivier.betrand@crhl.ulaval.ca |
Funders
Funder type
Industry
This is an investigator-initiated-trial which is funded by an unrestricted grant from GlaxoSmithKline
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2010 | 28/01/2019 | Yes | No |
Editorial Notes
28/01/2019: Publication reference added
