NCT00513630已完成4 期
Phase 4 Study on the Prognosis and Effect of Anti-diabetic Drugs on Type-2 Diabetes Mellitus With Coronary Artery Disease
Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 304 人开始时间: 2004年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- Composite of cardiovascular events which were defined as death from a cardiovascular cause, death from any cause, nonfatal myocardial infarction, nonfatal stroke or arterial revascularization
研究概览
简要总结
The purpose of this study is to explore the recurrence risk of cardiovascular events in patients with type 2 diabetes mellitus and coronary heart disease after different antidiabetic drug therapy (glipizide or metformin) by using an double-blind, randomized, parallel control and prospective study
The end point of this study is:
- follow up 3yr
- recurrence of cardiovascular event
- death caused by other reasons such as stroke, uremia, blindness and amputation
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
- Double
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coronary heart disease
- •Type 2 diabetes
排除标准
- •Severe organ dysfunction, psychopathy, infection, neutropenia
- •Congenital heart disease, rheumatic heart disease, severe arrhythmia, myocardiopathy
研究组 & 干预措施
metformin
Active Comparator
干预措施: Glipizide (Drug)
glipizide
Active Comparator
干预措施: Metformin (Drug)
结局指标
主要结局
Composite of cardiovascular events which were defined as death from a cardiovascular cause, death from any cause, nonfatal myocardial infarction, nonfatal stroke or arterial revascularization
次要结局
- New or worsening angina
- new or worsening heart failure
- new critical cardiac arrhythmia
- new peripheral vascular events
研究者
研究点 (1)
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