From August 1997 through December 1997, 10 patients were screened at the GCRC for VISP. Of those 10, only four had qualifying homocysteine levels and those patients were then enrolled in the trial. As of February 4, 1998, 125 patients had been enrolled nationally (they had expected 800 at this point). The VISP trial's randomization expectations have not thus been met, which is common in early phase of a clinical trial. It has recently been proposed that the homocysteine cutpoint be lowered from 10.5 to 9.5 umol/L to increase enrollment without sacrificing the power of the study. This change will be ruled on by Executive Committee before being indoctrinated. In the interim, we are still hoping to randomize 100 patients, although it may take longer than the 2 year period allotted for recruitment. The other 35 clinical sites are experiencing similar issues.
Showing the most recent 10 out of 343 publications
