What is the future for alteplase in stroke?

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Limited clinical evidence supports the use of IV alteplase as thrombolytic therapy for patients with acute ischaemic stroke. Results from the US National Institute of Neurological Disorders and Stroke (NINDS) trial indicated that IV alteplase 0.9 mg/kg improved patient outcome when administered within 3 hours of onset of stroke symptoms.*Nevertheless, further clinical data are needed to support the European licensing of alteplase in this indication. The first large multicentre European Cooperative Acute Stroke Study (ECASS I) failed to demonstrate a significant treatment benefit of alteplase compared with placebo in terms of the primary outcome measures.**However, a per-protocol target population analysis of ECASS I showed significant differences in favour of alteplase. Nevertheless, mortality was also increased. It was hoped that a second European study (ECASS II) would help provide a definitive answer to the question of whether early treatment with alteplase is beneficial in stroke. Unfortunately, the neutral results of ECASS II fail to definitively prove the case for alteplase therapy for patients with acute ischaemic stroke, delegates were told at the third Congress of the European Federation of Neurological Societies [Seville, Spain; September 1998].

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