Role of Rosiglitazone on Pre-Diabetes Mellitus and Coronary Artery Disease

Coronary Artery Disease Clinical Trial

Official title:

Role of Rosiglitazone Treatment and Secondary Prevention of Cardiovascular Events in Patients With Pre-Diabetes Mellitus and Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01574820
• Other study ID #: NCKUH HR95-10
• Status: Completed
• Phase: Phase 3
• First received: April 4, 2012
• Last updated: April 10, 2012
• Start date: November 2006
• Est. completion date: July 2011

Study information

• Verified date: April 2012
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

Objectives:

The investigators examined whether rosiglitazone, a thiazolidinedione (TZD), is beneficial for pre-diabetes mellitus (DM) adults with documented coronary artery disease (CAD).

Background:

Microvascular and macrovascular complications are common in type 2 DM. There is no evidence about the effects of TZDs, synthetic peroxisome proliferator-activated receptor (PPAR)-γ activators (insulin sensitizers and adipose transcriptional regulation and anti-inflammatory process activators) on pre-DM patients with documented CAD.

Description:

Materials and Methods:

This is a randomized, double-blind, placebo-controlled study, patients will be randomly assigned to the TZD group and to the placebo group with a 6-month treatment period.

Biomarkers will also examined before and 6 months post-treatment during the trial.

The primary end-points will be the diagnosis of major cardiovascular events: myocardial infarction, overt heart failure, and surgery or coronary intervention for CAD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: July 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• documented CAD by angiography

• insulin resistance or glucose intolerance

• 18 to 80 years of age

Exclusion Criteria:

• under DM treatment

• allergy to TZD

• active inflammation

• chronic disease under NSAID treatment

• active heart failure

• unwilling or unable to sign inform consents

Study Design

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Glucose Intolerance
• Insulin Resistance
• Myocardial Ischemia
• Prediabetes
• Prediabetic State

Intervention

Drug:
• placebo tablet
placebo tablet for 6 months
• rosiglitazone (4 mg)/day
rosiglitazone (4 mg)/day for 6 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major cardiovascular events, including myocardial infarction, overt heart failure, and surgery or coronary intervention for CAD	Primary end points: The primary end-point was defined as major cardiovascular events, including myocardial infarction, overt heart failure, and surgery or coronary intervention for CAD.	at least 6 months follow-up of MACEs	Yes
Secondary	Biomarkers measurements	Resistin and adiponectin will be measured to evaluate insulin resistance; CCL/MCP-1 and hsCRP were also analyzed to evaluate inflammation status changes.; Several vascular associated remodeling markers and proteins will also be measured.	Biomarkers were taken before the trial and 6 months later	No