Nils Gunnar Wahlgren BACKGROUND
Intravenous treatment with alteplase, a tissue plasminogen activator (t-PA), has now been approved by the European Union (EU) regulatory authorities for the treatment of acute ischaemic stroke within three hours of symptoms onset. Two major conditions were set for this approval. The first condition...
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| Language: | English |
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| Online Access: | http://citeseerx.ist.psu.edu/viewdoc/summary?doi=10.1.1.548.8866 http://www.acutestroke.org/Library/Wahlgren.pdf |
| Summary: | Intravenous treatment with alteplase, a tissue plasminogen activator (t-PA), has now been approved by the European Union (EU) regulatory authorities for the treatment of acute ischaemic stroke within three hours of symptoms onset. Two major conditions were set for this approval. The first condition was that all patients treated with alteplase during a three year period within the EU, Norway and Iceland will be registered in the SITS internet database in accordance with the SITS Monitoring Study (SITS-MOST) protocol. The second condition was that a randomised controlled study of alteplase versus placebo, later called ECASS III (European Co-operative Acute Stroke Study III), should be launched for patients who could be treated within a three to four hour time interval. SITS has accepted a request to provide the European Medicines Evaluation Agency (EMEA) with biannual reports on the proportions of patients who experience a symptomatic intracranial haemorrhage or die following treatment or who are independent for activities of daily living (ADL) at three months follow up. Treatment within 3 hours after onset of ischaemic stroke is highly effective, as indicated in the consensus statement of this conference in October 20001, which was based on the outcome of eight randomised controlled trials2-9. Intravenous t-PA was approved in US in 1996. Although the indication for this treatment seems widely accepted for patients within three hours of symptoms onset also in Europe, it has been claimed that the results were based on rather few patients included in randomised controlled trials10. There is also a concern about the risk for symptomatic intracranial haemorrhage caused by the treatment. Since many stroke experts would regard a randomised trial of t-PA versus placebo control within three hours of stroke onset as unethical, such a trial would probably not be feasible11. Collecting safety and efficacy data through an internet-based register, such as SITS, provides an opportunity to evaluate whether the rate of ... |
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