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DiabetesPhase 3VICTORYNCT00169832

Vein-Coronary Atherosclerosis And Rosiglitazone After Bypass Surgery: The VICTORY Trial

A Phase 3 study of Diabetes and Coronary Artery Bypass Grafting, run by Laval University at 9 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Diabetes, Coronary Artery Bypass Grafting
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
193 participants
Where
9 sitesin 2 countries
Study dates
Jun 2003to Jul 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 16Show fewer
  • 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.
  • Segment length of at least 20 mm in anastomosed native coronary artery corresponding to SVG chosen or, in case of impossibility of performing IVUS in the anastomosed coronary artery, a non grafted coronary artery (≥ 30 mm length segment) might be used for reference.

Who cannot join

  • 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.
Show all 36Show fewer
  • 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).
  • Known occlusion(s) of all SVG(s).
  • Treatment involving TZD within 3 mo prior to screening.
  • Chronic use (≥ 6 mo) of insulin for glycemic control at any time in the past or administration of insulin any time within the last 12 mo.
  • Allergy to contrast agents.
  • Current intake of anorectic agents or have been taken off an anorectic agent or equivalent within 3 mo prior to screening.
  • Patients for whom oral or injectable corticosteroids are used on a regular or recurrent basis.
  • Recent history/suspicion of current drug abuse or alcohol abuse within last 6 mo.
  • Women breast feeding, pregnant, or planning to become pregnant during conduct of trial and for 30 days after study completion.
  • Other illness that precludes survival.
  • History of malignancy within the last 5 yrs.
  • Concurrent participation in other investigational device or drug studies and/or having received any experimental therapeutic agents within 30 days of the screening.
  • Use of any investigational drug for glycemic control within 3 mo of the screening.
  • Patient travelling out of town/country for periods exceeding 2 mo.
  • Medical condition which may interfere with intake and/or absorption of study medication.
  • Patients unwilling or unable to comply with procedures.
  • Recent major surgery within 90 days of the screening.
  • AT IVUS AND ANGIOGRAPHY (VISIT 2):
  • PCI was performed on the target segment(s) after CABG.
  • Target SVG and/or target native coronary artery show ≥ 50% angiographic lesion precluding IVUS.
  • Thrombus/thrombus aspect in target vessels.
  • Target vessel has been subjected to surgical endarterectomy.

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

Canada6 sites

  • CRMSBC

    Bonaventure, Quebec, G0C 1E0

  • QEII Health Sciences Center - Halifax Infirmary

    Halifax, Nova Scotia, B3H 3A7

  • Hamilton Health Sciences - Mc Master Clinic

    Hamilton, Ontario, L8L 2X2

  • CHUM Notre-Dame Hospital

    Montreal, Quebec, H2L 4M1

  • Laval Hospital

    Sainte-Foy, Quebec, G1V 4G5

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

Other trials in Canada

Spain3 sites

  • Hospital Del Mar

    Barcelona

  • Hospital Universitari Vall D'Hebron

    Barcelona

  • Hospital Universitarion Son Dureta

    Palma de Mallorca

Other trials in Spain

About this 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

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.
Read more

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.
Read the 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 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.

Being tested
Rosiglitazone or placebo
Keywords
Atherosclerosis progression, Ischemic heart disease, Saphenous vein graft, Metabolic risk factors, Rosiglitazone
Medical subject headings
Diabetes Mellitus, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rosiglitazone or placeboDrug

    Also called Avandia

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

Study groups in NCT00169832
Study groupRoleWhat they receive
Rosiglitazone (Avandia)ExperimentalNot described
Receives: Drug: Rosiglitazone or placebo
PlaceboPlacebo comparatorNot described
Receives: Drug: Rosiglitazone or placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in plaque volume in one SVG (by IVUS)

    Measured: 12 months

Secondary outcomes (14)

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

    Measured: 12 months

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

    Measured: 12 months

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

    Measured: 12 months

  4. 4 Patients showing atherosclerosis changes

    Measured: 12 months

  5. 5 Atherosclerosis changes concordance and discordance

    Measured: 12 months

  6. 6 New occlusions in native coronary arteries or SVGs

    Measured: 12 months

  7. 7 Changes in reference and minimum lumen diameters of the SVG

    Measured: 12 months

  8. 8 Per patient percentage of initially patent SVGs that had significant progression of atherosclerosis at the site of greatest change at follow-up

    Measured: 12 months

  9. 9 Changes 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

    Measured: 12 months

  10. 10 Changes in abdominal areas and volumes of adipose tissue areas

    Measured: 12 months

  11. 11 Changes in body composition, body weight, waist circumference and BMI

    Measured: 12 months

  12. 12 Clinical laboratory parameters, physical examinations, vital signs, ECGs, concomitant medication and adverse events

    Measured: 12 months

  13. 13 Death, MI, TIA, stroke, hospitalization and ischemia-driven interventions

    Measured: 12 months

  14. 14 Fluid retention

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2005 (estimated)
  2. Study startJun 2003
  3. Primary completionJul 2007
  4. Study completionJul 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
193 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00169832
Sponsor's protocol ID
49653/416
Other IDs
ISRCTN54136716
Acronym
VICTORY
Status last verified
Oct 2008
First submitted
12 Sep 2005
Last updated
10 Oct 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20594555

Questions about this trial

What is this clinical trial studying?

A Phase 3 study of Diabetes and Coronary Artery Bypass Grafting, run by Laval University at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Canada, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in plaque volume in one SVG (by IVUS) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00169832, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2008.

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