Alteplase effective for ischaemic stroke within 4.5 hours, ISA accepts ECASS 3 Study
The Indian Stroke Association joined its many counterparts across the world in recognizing that Alteplase is effective even if it is administered within 4.5 hours of onset of ischaemic stroke.
This recognition followed after the recommendations from the European Stroke Organisation (ESO), the American Stroke Association and the Lancet based on the key results from the European Cooperative Acute Stroke Study (ECASS 3). It was earlier believed that Alteplase would be effective only even if it was administered within 3 hours of the onset of ischaemic stroke in a patient, a release said.
ECASS 3, a randomised, double-blind, placebo-controlled trial, showed for the first time that thrombolysis with Alteplase can increase the likelihood of achieving good outcome with only minimal or no disability after an acute ischaemic stroke when administered in an extended time-window from 3 to 4.5 hours after symptom onset. This news comes shortly after The Lancet selected ECASS 3 as one of the top three papers of 2008, and Lancet editors singled out the study as their choice for paper of the year.
The World Health Organization estimates that 5.7 million people in the world die each year from stroke. Among survivors, 40 per cent experience moderate to severe disability and 10 per cent require institutional care. For patients with an acute ischaemic stroke the only treatment currently available is Alteplase, which has to be administered within 3 hours of symptom onset according to its currently approved label.
According to WHO's Workshop Report on Stroke Surveillance in India by the Division of Non-Communicable Diseases by the government and the Indian Council of Medical Research, there are 16,67,372 stroke attacks in India every year and 4568 stroke attacks everyday. Of this, 800-1000 people die of stroke everyday whereas 1000-1500 people get paralysed for life after they suffer from stroke.
Dr Subhash Kaul, president of Indian Stroke Association said, "We are proud of the success of ECASS 3 and would like to thank everyone who participated in this landmark study on acute ischaemic stroke for having achieved this breakthrough in stroke treatment.”
“This time-window of an additional 1.5 hours is like a miracle of hope and life for a stroke victim for whom every ticking second is precious,” said Dr M V Padma, associate professor, Department of Neurology, AIIMS.
The ECASS 3 trial was set up to investigate whether Alteplase can also safely extend the benefit of treatment in the 3 to 4.5 hour time window. ECASS 3 included 821 patients in 15 European countries who were recruited by a team of investigators led by Professor Werner Hacke of the University of Heidelberg. Results were published in the New England Journal of Medicine in September 2008.