Advertisement

Topics

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

2014-07-23 21:48:34 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Diabetes

Intervention

Rosiglitazone or placebo

Location

QEII Health Sciences Center - Halifax Infirmary
Halifax
Nova Scotia
Canada
B3H 3A7

Status

Completed

Source

Laval University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:48:34-0400

Clinical Trials [1716 Associated Clinical Trials listed on BioPortfolio]

Efficacy and Safety Study of Rosiglitazone/Metformin Therapy vs Rosiglitazone and Metformin in Type 2 Diabetes Subjects

The purpose of this 32 week study is to demonstrate that fixed-dose combination treatment with rosiglitazone/metformin will safely and effectively control glycemia as first line oral thera...

Rosiglitazone Versus Placebo in Chronic Stable Angina

We wish to see if the drug rosiglitazone, currently used in the treatment of type 2 diabetes, could be used as a new treatment for angina when compared with placebo in overweight subjects ...

Effects of Rosiglitazone and Metformin on Metabolism in Type 2 Diabetes

The objectives of this study are to compare the effects of rosiglitazone and metformin on insulin stimulated glucose uptake in subjects with type 2 diabetes. Whole body, and skeletal muscl...

Rosiglitazone In Subjects With Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin

This 24-week study will compare the effects of adding the drug rosiglitazone (2mg and 4mg) or placebo to insulin in patients with Type 2 diabetes mellitus (non-insulin-dependent) who have ...

The DREAM (Diabetes Reduction Assessment With Ramipril and Rosiglitazone Medication) Trial

The purpose of this study is to determine if ramipril and/or rosiglitazone prevent the onset of type 2 diabetes.

PubMed Articles [4716 Associated PubMed Articles listed on BioPortfolio]

Effects of metformin, rosiglitazone and insulin on bone metabolism in patients with type 2 diabetes.

Fracture risk is increased in individuals with type 2 diabetes (T2D). The pathophysiological mechanisms accentuating fracture risk in T2D are convoluted, incorporating factors such as hyperglycaemia, ...

Rosiglitazone lowers resting and blood pressure response to exercise in men with type 2 diabetes: a 1 year randomized study.

Individuals with type 2 diabetes (T2D) are insulin resistant and have a lower exercise capacity than individuals without T2D.

Effects of Placebo-controlled Insulin-sensitizing Drugs on Hormonal Parameters in Polycystic Ovary Syndrome Patients: A Network Meta-analysis.

This network meta-analysis was conducted to compare effects of different placebo-controlled insulin-sensitizing drugs, including metformin, pioglitazone, rosiglitazone and troglitazone on hormonal par...

Effect of a Glucagon Receptor Antibody (REMD-477) in Type 1 Diabetes: A Randomized Controlled Trial.

The aim of the current study was to study the efficacy and safety of REMD-477, a glucagon receptor antagonist, in type 1 diabetes. This was a randomized controlled trial in which 21 patients with type...

Zinc supplementation in pre-diabetes: A randomized double-blind placebo-controlled clinical trial.

To evaluate the effects of Zinc supplementation on glycaemic control, other cadio-metabolic/anthropometric parameters and progression of disease in pre-diabetes.

Medical and Biotech [MESH] Definitions

Urination of a large volume of urine with an increase in urinary frequency, commonly seen in diabetes (DIABETES MELLITUS; DIABETES INSIPIDUS).

The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).

A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.

The state of PREGNANCY in women with DIABETES MELLITUS. This does not include either symptomatic diabetes or GLUCOSE INTOLERANCE induced by pregnancy (DIABETES, GESTATIONAL) which resolves at the end of pregnancy.

Excessive thirst manifested by excessive fluid intake. It is characteristic of many diseases such as DIABETES MELLITUS; DIABETES INSIPIDUS; and NEPHROGENIC DIABETES INSIPIDUS. The condition may be psychogenic in origin.

More From BioPortfolio on "Vein-Coronary Atherosclerosis And Rosiglitazone After Bypass Surgery: The VICTORY Trial"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Diabetes
Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. The two main types of diabetes are: type 1 diabetes type 2 diabetes In the UK, diabetes affects approximately 2.9 million people. There are a...


Searches Linking to this Trial