This is a multi-center study funded by NIH to determine whether the addition of pharmacological doses of folic acid, pyridoxine, and cyanocobalamin reduces recurrent cerebral infarction as a primary endpoint and myocardial infarction or fatal coronary heart disease as a secondary endpoint. Baseline screenings were performed in 1788 patients. Blood was screened in 61 subjects who were eligible from clinical criteria. Of these, 37 patients were eligible by plasma homocystein level criteria and 24 subjects were ineligible. Of the 37 eligible subjects, 26 have been randomized as of January 22, 1999. There were 6 patients who were eligible by homocystein concentrations that refused to participate after the blood draw. Seven subjects are awaiting randomization. To date there have been no significant adverse side-effects. As of the last report from the central office, no significant adverse side-effects have been reported in any of the other sites. As can be seen from the above numbers, the main rate limiting step, out of human control, is the results of the plasma homocysteine levels. Approximately 40% of subjects who were clinically eligible were found to be ineligible by virtue of plasma homocystein concentrations, as determined by the central site of analysis, being below the concentration required for patient randomization into the study. Our goal is to continue to recruit subjects, up to 100 total, or as required by the trial central office.
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