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| [ ...Back to search results ] | [ Print-friendly version ] |
| 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 |
| ClinicalTrials.gov identifier | NCT00169832 |
| Public title | A Multi-center Randomized Double-Blind Trial Comparing Rosiglitazone to Placebo for the Prevention of Atherosclerosis Progression after Coronary Bypass Surgery in Diabetic Patients |
| Scientific title | |
| Acronym | VeIn-Coronary aTherOsclerosis and Rosiglitazone after bypass surgerY. The VICTORY Trial. |
| Serial number at source | 49653/416 |
| 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 |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Diabetes |
| Participants - 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. |
| Participants - exclusion criteria | Not provided at time of registration |
| Anticipated start date | 01/04/2003 |
| Anticipated end date | 30/06/2006 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 280 |
| Interventions |
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. |
| Primary outcome measure(s) | 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 measure(s) |
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 patient’s 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 |
| Sources of funding | This is an investigator-initiated-trial which is funded by an unrestricted grant from GlaxoSmithKline |
| Trial website | |
| Publications | |
| Contact name | Dr Olivier Bertrand |
| Address |
Laval Hospital
2725 Chemin Ste Foy |
| City/town | Québec |
| Zip/Postcode | G1V 4G5 |
| Country | Canada |
| Tel | +1 418 656 8711 ext 3136 |
| Fax | +1 418 656 4904 |
| olivier.bertrand@crhl.ulaval.ca | |
| Sponsor | Laval Hospital Research Center (Canada) |
| Address | 2725 Chemin Ste Foy |
| City/town | Québec |
| Zip/Postcode | G1V 4G5 |
| Country | Canada |
| Tel | +1 418 656 8711 |
| Fax | +1 418 656 4904 |
| olivier.betrand@crhl.ulaval.ca | |
| Date applied | 29/01/2005 |
| Last edited | 04/10/2007 |
| Date ISRCTN assigned | 21/02/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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