Role of Rosiglitazone Treatment and Secondary Prevention of Cardiovascular Events in Patients With Pre-Diabetes Mellitus and Coronary Artery Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 105
- 主要终点
- major cardiovascular events, including myocardial infarction, overt heart failure, and surgery or coronary intervention for CAD
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •documented CAD by angiography
- •insulin resistance or glucose intolerance
- •18 to 80 years of age
排除标准
- •under DM treatment
- •allergy to TZD
- •active inflammation
- •chronic disease under NSAID treatment
- •active heart failure
- •unwilling or unable to sign inform consents
研究组 & 干预措施
placebo
干预措施: placebo tablet (Drug)
rosiglitazone (4 mg)/day
干预措施: rosiglitazone (4 mg)/day (Drug)
结局指标
主要结局
major cardiovascular events, including myocardial infarction, overt heart failure, and surgery or coronary intervention for CAD
时间窗: at least 6 months follow-up of MACEs
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.
次要结局
- Biomarkers measurements(Biomarkers were taken before the trial and 6 months later)