Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169832
Status:
COMPLETED
Last Update Posted:
2008-10-10
First Post:
2005-09-12
Brief Title:
Vein-Coronary Atherosclerosis And Rosiglitazone After Bypass Surgery The VICTORY Trial
Sponsor:
Laval University
Organization:
Laval University
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Trial Comparing Rosiglitazone to Placebo for the Prevention of Atherosclerosis Progression After Coronary Bypass Surgery in Diabetic Patients
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VICTORY
Brief Summary:
HYPOTHESES
Rosiglitazone in diabetic patients with previous coronary bypass surgery may prevent or slow the progression of atherosclerosis in SVGs and native coronary arteries
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
Rosiglitazone therapy influences favorably metabolism and clinical outcomes in diabetic patients after coronary artery bypass surgery
OBJECTIVES
PRIMARY To assess the efficacy of rosiglitazone to reduce atherosclerosis progression in vein grafts in diabetic patients after coronary bypass surgery by using IVUS imaging after a 12 mo follow-up
SECONDARY
To prospectively compare the secondary IVUS endpoints
To prospectively compare the angiographic endpoints
To prospectively compare the metabolic risk factor endpoints
To prospectively compare the body composition and distribution endpoints
To prospectively compare the clinical outcomes of rosiglitazone versus standard care using composite endpoints
Rosiglitazone in diabetic patients with previous coronary bypass surgery may prevent or slow the progression of atherosclerosis in SVGs and native coronary arteries
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
Rosiglitazone therapy influences favorably metabolism and clinical outcomes in diabetic patients after coronary artery bypass surgery
OBJECTIVES
PRIMARY To assess the efficacy of rosiglitazone to reduce atherosclerosis progression in vein grafts in diabetic patients after coronary bypass surgery by using IVUS imaging after a 12 mo follow-up
SECONDARY
To prospectively compare the secondary IVUS endpoints
To prospectively compare the angiographic endpoints
To prospectively compare the metabolic risk factor endpoints
To prospectively compare the body composition and distribution endpoints
To prospectively compare the clinical outcomes of rosiglitazone versus standard care using composite endpoints
Detailed Description:
STUDY DESIGN
This is a prospective multicenter randomized placebo-controlled double-blind trial assessing the efficacy and safety of rosiglitazone in the prevention of atherosclerosis progression in vein grafts and native coronary arteries of diabetic patients Stable diabetic patients with previous coronary bypass surgery 1 year 10 years will be screened After baseline evaluation all eligible patients will undergo baseline coronary angiogram IVUS will be performed in a segment length of at least 40 mm in a SVG suitable for IVUS analysis and in a segment length of at least 20 mm in the anastomosed native coronary artery corresponding to the SVG chosen Following the IVUS procedure patients will be randomized to either rosiglitazone treatment or to placebo in addition to their standard clinical care Study drug will be titrated over an 8-week period up to a dose of 8 mgday or to maximum tolerated dose The patients will receive the study drug or the placebo for 50-54 weeks in a double-blind manner At the beginning and at 2 4 6 8 10 and 12 months of treatment patients will be subjected to a set of morphological physiological and metabolic evaluations At the final visit 12 months patients will also be submitted to IVUS and angiography
This is a prospective multicenter randomized placebo-controlled double-blind trial assessing the efficacy and safety of rosiglitazone in the prevention of atherosclerosis progression in vein grafts and native coronary arteries of diabetic patients Stable diabetic patients with previous coronary bypass surgery 1 year 10 years will be screened After baseline evaluation all eligible patients will undergo baseline coronary angiogram IVUS will be performed in a segment length of at least 40 mm in a SVG suitable for IVUS analysis and in a segment length of at least 20 mm in the anastomosed native coronary artery corresponding to the SVG chosen Following the IVUS procedure patients will be randomized to either rosiglitazone treatment or to placebo in addition to their standard clinical care Study drug will be titrated over an 8-week period up to a dose of 8 mgday or to maximum tolerated dose The patients will receive the study drug or the placebo for 50-54 weeks in a double-blind manner At the beginning and at 2 4 6 8 10 and 12 months of treatment patients will be subjected to a set of morphological physiological and metabolic evaluations At the final visit 12 months patients will also be submitted to IVUS and angiography
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN54136716 | None | None | None |