Controversial stroke trial is under review following BMJ report

A leading US institute has asked for a review of the trial results published in 1995 that led to a change in the American Heart Association's guidelines on use of the thrombolytic agent alteplase. It follows a report in the BMJ earlier this year which showed that the majority of the association's experts on stroke had ties to the manufacturers of the drug.

The National Institute of Neurological Diseases and Stroke (NINDS) has invited an independent committee to re-analyse the data from a five year, multisite trial, the results of which were published in the New England Journal of Medicine on 14 December 1995.

The results were cited by the American Heart Association as the main reason for changing their advice in 2000 on the use of alteplase (tPA, also known as rt-PA) for stroke, moving it up from “optional (class IIb)” to “definitely recommended (class I),” despite continuing controversy over the safety and efficacy of the treatment.

W Michael O'Fallon, professor of biostatistics and chairman of the independent committee, said the review was triggered …