The trial’s independent safety and efficacy monitoring committee (SEMC) observed a safety concern from trial data collected thus far and is in the process of evaluating the entire benefit-risk profile of Reopro for acute ischemic stroke patients before coming to a final recommendation of whether or not enrollment in the trial should resume.
Dosing of patients already enrolled in the trial has also been suspended. Data so far collected from these patients will be reviewed before the SEMC provides its recommendation on how to proceed with the trial.
“Safety is our top priority, so we are halting enrollment in order for the SEMC to carefully evaluate the data and determine whether the benefit-risk profile of Reopro for the treatment of acute ischemic stroke warrants reinitiating trial enrollment,” said Dr Jerome Boscia, senior vice president, Clinical R&D, Centocor. “It is important to note, however, that Reopro has an established favorable benefit-risk profile for its approved uses in people undergoing coronary procedures such as angioplasty or stenting.”