t-PA Review Committee
In May 2002, the NINDS invited an independent committee to review and consider the data from the 5-year, multi-site study of "Tissue Plasminogen Activator for Acute Ischemic Stroke," published by the NINDS r-TPA Stroke Study Group in the New England Journal of Medicine, December 14, 1995. The study represents the first treatment for acute ischemic stroke, and the therapeutic agent t-PA was approved by the FDA for this usage in June of 1996. The NINDS asked that the committee "address whether there is concern that eligible stroke patients may not benefit from rt-PA given according to the protocol used in the (NINDS) trials, and whether any subgroup imbalances invalidate the trial as claimed by some of the critics."
The findings of the Review Committee are summarized in these documents.