Multicenter trial of elective revascularization in patients with diabetes mellitus and mild anginal complaints

Academic Medical Centre (AMC) (Netherlands)0 sites800 target enrollmentDecember 20, 2005

Overview

No summary available.

Registry

who.int

Start Date

December 20, 2005

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

Academic Medical Centre (AMC) (Netherlands)

•1\. A history of diabetes mellitus type 2, evidenced by either of the following
•1\.1 Treatment with oral antidiabetic medication
•1\.2 Treatment with insulin after a period of treatment with oral antidiabetic medication
•1\.3 Treatment with insulin, started after the 50th year
•1\.4 A fasting plasma glucose concentration of at least 7\.0 mmol/l or a non\-fasting glucose concentration of at least 11\.0 mmol/l, in two samples taken on separate days
•2\. Stable mild complaints of angina pectoris (Canadian Cardiovascular Society class I or II, on medical treatment)

•1\. Younger than 30 years of age
•2\. Previous myocardial infarction and/or acute coronary syndrome in the previous two months
•3\. Unstable angina (any category in Braunwald's classification) in the previous two months
•4\. Previous percutaneous intervention in the previous six months
•5\. Serious complaints of effort angina pectoris (CCS class III or IV)
•6\. Known coronary anatomy unsuited for coronary revascularization
•7\. An ejection fraction of less than 35%, measured by any technique
•8\. Contra\-indication for bypass surgery (i.e. co\-morbidity)
•9\. History of a hemorrhagic stroke at any time, or stroke or transient ischemic accident (TIA) of any etiology within 30 days of randomization
•10\. History of a bleeding diathesis, or evidence of active abnormal bleeding within 30 days of randomization