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Completed

NCT Number: NCT00513630

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

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

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Key information

Conditions

Type 2 Diabetes Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shanghai Jiao Tong University School of Medicine

Shanghai, 200025, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glipizide

Drug

metformin

Drug

Primary outcomes

  1. 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 outcomes

  1. New or worsening angina

  2. new or worsening heart failure

  3. new critical cardiac arrhythmia

  4. new peripheral vascular events

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Acronym: SPREADDIMCAD

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Aug 8, 2007
Registry last updated
Apr 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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