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NCT00513630 Clinical Trial

Study on the Prognosis and Effect of Anti-diabetic Drugs on Type-2 Diabetes Mellitus With Coronary Artery Disease

Coronary Artery Disease Clinical Trial

— SPREADDIMCAD  

Official title:
Phase 4 Study on the Prognosis and Effect of Anti-diabetic Drugs on Type-2 Diabetes Mellitus With Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00513630
Other study ID # CCEMD002
Secondary ID
Status Completed
Phase Phase 4
First received August 7, 2007
Last updated April 25, 2011
Start date June 2004
Est. completion date July 2010

Study information
Verified date December 2010
Source Shanghai Jiao Tong University School of Medicine
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

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:

1. follow up 3yr

2. recurrence of cardiovascular event

3. death caused by other reasons such as stroke, uremia, blindness and amputation

Recruitment information / eligibility
Status Completed
Enrollment 304
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group N/A to 80 Years
Eligibility Inclusion Criteria:

- Coronary heart disease

- Type 2 diabetes

Exclusion Criteria:

- Severe organ dysfunction, psychopathy, infection, neutropenia

- Congenital heart disease, rheumatic heart disease, severe arrhythmia, myocardiopathy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Glipizide

• Metformin

Locations
Country Name City State
China Shanghai Jiao Tong University School of Medicine Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Secondary New or worsening angina
Secondary new or worsening heart failure
Secondary new critical cardiac arrhythmia
Secondary new peripheral vascular events
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