Intravenous rt-PA: a tenth anniversary reflection

Background: Clinical trials with rt-PA for treating AIS began 20 years ago in 1987, and the pivotal NINDS rt-PA Stroke Study was completed and published in 1995 with FDA approval in 1996, about 10 years ago. A large number of articles emanated from that study and have established the efficacy and generalizability of this treatment. Methods: Here we summarize the background of how the NINDS trial was developed and carried out and its main findings. Results: The NINDS rt-PA Stroke Study resulted from preclincal and pilot studies and paralleled similar studies carried out around the world. Its positive results, compared with the other trials, probably were due to the early time window for treatment and well-organized clinical and statistical centers. Many controversies have surrounded its use since its approval. As a result of the NINDS rt-PA Stroke Study, many new approaches to thrombolytic therapy are under evaluation. Conclusion: The results of the NINDS rt-PA Stroke Study have affected the management of patients with acute stroke worldwide. (c) 2007 Elsevier Inc. All rights reserved.