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| Sponsor: | Laval University |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | Laval University |
| ClinicalTrials.gov Identifier: | NCT00169832 |
Purpose
HYPOTHESES
OBJECTIVES
SECONDARY
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Coronary Artery Bypass Grafting |
Drug: Rosiglitazone or placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Enrollment: | 193 |
| Study Start Date: | June 2003 |
| Study Completion Date: | July 2007 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Rosiglitazone (Avandia): Experimental |
Drug: Rosiglitazone or placebo
Rosiglitazone 4 to 8 mg/day or placebo, for 12 months
|
| Placebo: Placebo Comparator |
Drug: Rosiglitazone or placebo
Rosiglitazone 4 to 8 mg/day or placebo, for 12 months
|
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 mg/day (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.
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
AT SCREENING:
AT IVUS & ANGIOGRAPHY (VISIT 2):
Subject eligible if at least 1), 2) and 3) of the following criteria apply:
Reference of target (SVG) diameter ≥ 2.5 mm.
If anastomosed native coronary artery or non grafted coronary artery can be evaluated, the following criteria must be met:
Exclusion Criteria:
AT SCREENING:
AT IVUS AND ANGIOGRAPHY (VISIT 2):
Contacts and Locations| Canada, Nova Scotia | |
| QEII Health Sciences Center - Halifax Infirmary | |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
| Canada, Ontario | |
| Toronto General Hospital | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Hamilton Health Sciences - Mc Master Clinic | |
| Hamilton, Ontario, Canada, L8L 2X2 | |
| Canada, Quebec | |
| Laval Hospital | |
| Sainte-Foy, Quebec, Canada, G1V 4G5 | |
| CHUM Notre-Dame Hospital | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| CRMSBC | |
| Bonaventure, Quebec, Canada, G0C 1E0 | |
| Spain | |
| Hospital Universitari Vall D'Hebron | |
| Barcelona, Spain | |
| Hospital Universitarion Son Dureta | |
| Palma de Mallorca, Spain | |
| Hospital Del Mar | |
| Barcelona, Spain | |
| Principal Investigator: | Olivier F Bertrand, MD, PhD | Laval Hospital Research Center |
| Principal Investigator: | Jean-Pierre Despres, PhD | Laval Hospital Research Center |
| Principal Investigator: | Paul Poirier, MD, PhD | Laval Hospital Research Center |
More Information
| Responsible Party: | Hopital Laval ( Olivier F Bertrand, MD PhD ) |
| Study ID Numbers: | 49653/416, ISRCTN54136716 |
| Study First Received: | September 12, 2005 |
| Last Updated: | October 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00169832 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Atherosclerosis progression Ischemic heart disease Saphenous vein graft Metabolic risk factors Rosiglitazone |
|
Atherosclerosis Arterial Occlusive Diseases Heart Diseases Myocardial Ischemia Physiological Effects of Drugs Vascular Diseases Arteriosclerosis |
Pharmacologic Actions Coronary Disease Hypoglycemic Agents Cardiovascular Diseases Rosiglitazone Coronary Artery Disease |