This multicenter, double-blinded, randomized clinical trial has been designed to determine whether the addition of a multivitamin with high dose folic acid, pyridoxine (vitamin B6) and cyanocobalamin (vitamin B12) to best medical/surgical management and risk factor modification reduces recurrent cerebral infarction (primary end point) and myocardial infarction or fatal coronary heart disease (CHD, secondary endpoint) in patients with a nondisabling cerebral infarctioin(NDCI) who have basal homocyst(e)ine levels above 9.5 millimol/L at screening. The fundamental eligibility criteria are the occurrence of a NDCI within 120 days prior to randomization and a qualifying homocyst(e)ine level. All patients will receive best management for risk factor reduction, which includes counseling and interventions for hypertension, high low-density lipoprotein, low high -density lipoprotein, tobacco use, diabetes and other recognized factors which add excess risk for cerebral and myocardial infarction.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000080-38
Application #
6420810
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1978-12-01
Project End
2003-11-30
Budget Start
Budget End
Support Year
38
Fiscal Year
2000
Total Cost
Indirect Cost
Name
Case Western Reserve University
Department
Type
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106
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