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