NCT00169832

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
193

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline
Completed

Started Jun 2003

Longer than P75 for phase_3 diabetes

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

October 10, 2008

Status Verified

October 1, 2008

Enrollment Period

4.1 years

First QC Date

September 12, 2005

Last Update Submit

October 9, 2008

Conditions

DiabetesCoronary Artery Bypass Grafting

Keywords

Atherosclerosis progressionIschemic heart diseaseSaphenous vein graftMetabolic risk factorsRosiglitazone

Outcome Measures

Primary Outcomes (1)

  • Change in plaque volume in one SVG (by IVUS)

    12 months

Secondary Outcomes (14)

  • 1 Change in plaque volume in segment of anastomosed coronary artery

    12 months

  • 2 Changes in lumen and total vessel volumes and lumen plaque total vessel areas in SVG and coronary segments

    12 months

  • 3 Changes in qualitative plaque characterization in the SVG and coronary segments

    12 months

  • 4 Patients showing atherosclerosis changes

    12 months

  • 5 Atherosclerosis changes concordance and discordance

    12 months

  • +9 more secondary outcomes

Study Arms (2)

Rosiglitazone (Avandia)

EXPERIMENTAL
Drug: Rosiglitazone or placebo

Placebo

PLACEBO COMPARATOR
Drug: Rosiglitazone or placebo

Interventions

Rosiglitazone or placeboDRUG

Rosiglitazone 4 to 8 mg/day or placebo, for 12 months

Also known as: Avandia
PlaceboRosiglitazone (Avandia)

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • AT SCREENING:
  • Male or female, aged ≥ 40 years \& ≤ 75 years.
  • Women of childbearing potential with contraceptive measure, or of non-childbearing potential or surgically sterile.
  • Type 2 diabetes mellitus.
  • Patients with no new medication for hyperglycemia and no change in dose of oral hypoglycemic medication within the last 3 mo prior to screening.
  • Diabetic patients with ischemic heart disease and CABG with at least one SVG (≥1 yr \& ≤10 yrs).
  • Patient agrees to participate.
  • Patient legally capable of giving consent and understand what participation in study entails, potential risks and benefits, freedom to withdraw without any prejudice to subsequent medical arrangement or treatment, sign an ICF prior to any protocol specific procedure.
  • AT IVUS \& ANGIOGRAPHY (VISIT 2):
  • Subject eligible if at least 1), 2) and 3) of the following criteria apply:
  • Patient with at least 1 patent SVG.
  • Segment length of at least 40 mm in SVG suitable for IVUS.
  • 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:
  • Reference of target anastomosed native coronary artery or non grafted coronary artery diameter≥ 2.5 mm.
  • +1 more criteria

You may not qualify if:

  • AT SCREENING:
  • Clinically significant abnormality at screening tests \& exams.
  • Type 1 diabetes or history of diabetic ketoacidosis.
  • Uncontrolled type 2 diabetes mellitus.
  • Recent MI or ACS (≤ 90 days).
  • History of hypersensitivity to thiazolidinediones (TZD) or compounds of similar chemical structures.
  • Last LVEF≤ 35%.
  • SBP\>170mmHg or DBP\>100mmHg at screening/baseline should be appropriately treated and under control prior to randomization.
  • Unstable or Canadian Cardiovascular Society class III and IV angina, acute heart failure or congestive heart failure (NYHA class III and IV).
  • History of hepatocellular reaction/severe oedema/other potentially fluid-related AE associated with use of any TZD or PPAR-γ agonist.
  • Hepatic disease.
  • Renal dysfunction.
  • Anemia.
  • TG ≥ 10 mmol/L.
  • History of PCI in all SVG(s).
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

QEII Health Sciences Center - Halifax Infirmary

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Hamilton Health Sciences - Mc Master Clinic

Hamilton, Ontario, L8L 2X2, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

CRMSBC

Bonaventure, Quebec, G0C 1E0, Canada

Location

CHUM Notre-Dame Hospital

Montreal, Quebec, H2L 4M1, Canada

Location

Laval Hospital

Sainte-Foy, Quebec, G1V 4G5, Canada

Location

Hospital Del Mar

Barcelona, Spain

Location

Hospital Universitari Vall D'Hebron

Barcelona, Spain

Location

Hospital Universitarion Son Dureta

Palma de Mallorca, Spain

Location

Related Publications (1)

  • Bertrand OF, Poirier P, Rodes-Cabau J, Rinfret S, Title LM, Dzavik V, Natarajan M, Angel J, Batalla N, Almeras N, Costerousse O, De Larochelliere R, Roy L, Despres JP; VICTORY Trial Investigators. Cardiometabolic effects of rosiglitazone in patients with type 2 diabetes and coronary artery bypass grafts: A randomized placebo-controlled clinical trial. Atherosclerosis. 2010 Aug;211(2):565-73. doi: 10.1016/j.atherosclerosis.2010.06.005. Epub 2010 Jun 11.

    PMID: 20594555DERIVED

MeSH Terms

Conditions

Diabetes MellitusMyocardial Ischemia

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

June 1, 2003

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

October 10, 2008

Record last verified: 2008-10

Locations

CA(6)ES(3)