The enrollment in the Abciximab in Emergent Stroke Treatment Trial-II ( AbESTT-II ), the phase III trial of ReoPro ( Abciximab ) for the treatment of acute ischemic stroke, has been temporarily suspended.

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 Abciximab for acute ischemic stroke patients before coming to a final recommendation of whether or not enrollment in the trial should resume.
Patients currently enrolled in the trial will not receive additional study drug and data for these patients will be reviewed before the SEMC provides its recommendation on how to proceed with the AbESTT-II trial.

Reopro is currently indicated as an adjunct to percutaneous coronary intervention ( PCI ) for the prevention of cardiac ischemic complications in patients undergoing PCI and in patients with unstable angina not responding to conventional medical therapy when PCI is planned within 24 hours.

AbESTT-II is a phase III, multinational, multicenter, randomized, double-blind placebo-controlled study evaluating the safety and efficacy of ReoPro in improving neurological function and minimizing disability in patients who have had an acute ischemic stroke.

Preliminary results from other trials suggested that ReoPro might be useful in the treatment of stroke beyond the 3-hour time window in which the only currently approved therapy is used to dissolve blood clots in ischemic stroke patients.

Most stroke patients do not arrive in the emergency department within 3 hours of symptom onset.

The trial evaluates two populations: patients randomized within 4.5 hours with planned treatment within 5 hours of stroke onset ( primary analysis population, n=1200 ) and a companion population of patients randomized 4.5-5.5 hours after stroke onset with planned treatment within 6 hours or who awaken with stroke symptoms and can be randomized within 2.5 hours of awakening ( n=600 ).

In May 2005, treatment of the small segment of patients awakening after having suffered a stroke was stopped because of an increased risk of intracranial hemorrhage in that population.
At that time, the SEMC recommended continuing enrollment with the remaining groups being evaluated in the trial.

Approximately 150 clinical trial sites are participating in the AbESTT-II worldwide trial, which began in 2003. The goal for enrollment was 1800 participants.

Source: Centocor, 2005


XagenaMedicine2005