NICE recommends treatment with alteplase is started as early as possible, within 4.5 hours of onset of ischaemic stroke symptoms



Acute Ischaemic Stroke


Actilyse (alteplase, rt-PA)

NICE has issued final guidance on the use of alteplase (Actilyse) for the treatment of acute ischaemic stroke[1], which recommends initiation of treatment within 4.5 hours of onset of ischaemic stroke symptoms. This will give more patients access to thrombolytic therapy, though it remains crucial that doctors treat stroke patients as early as possible.

This recommendation comes as the result of a review of existing NICE guidance for Actilyse in stroke,

prompted by an extension to the marketing authorisation which allows the initiation of Actilyse from 3 to 4.5 hours from the onset of ischaemic stroke symptoms.

The NICE Appraisal Committee concluded that Actilyse administered between 0 and 4.5 hours after onset of stroke symptoms was a cost-effective treatment for acute ischaemic stroke as it decreases the probability of disability, death or dependence. Data suggests that extension of the licence has the potential to make alteplase treatment available to between 2-4.7% more people who suffer an acute ischaemic stroke[2, 3].

The recommendation made by NICE that treatment should be started as early as possible within 4.5 hours of onset of stroke symptoms is vitally important. An extended treatment window from 3 to 4.5 hours allows a greater number of eligible patients to be safely and effectively thrombolysed, but it is crucial to keep in mind that the Actilyse licence extension provides more time for patients, not for clinicians; it remains necessary that patients eligible for thrombolysis are treated without delay to maximise effectiveness.


Notes to editors

About Actilyse®: Stroke is a neurological emergency that can affect a specific area, or sometimes all of the brain. It can be caused by a burst blood vessel (haemorrhagic stroke) or occur when a vessel is obstructed by a blood clot (ischaemic stroke). Actilyse® (active ingredient: alteplase), is now in the majority of EU approved for use within 4.5 hours from the onset of symptoms in ischaemic stroke. It is a recombinant tissue plasminogen activator (rt-PA), a genetically engineered version of naturally occurring tissue plasminogen activator, which has the biological function of removing small clots that routinely form in the bloodstream. Actilyse® is the only drug indicated for thrombolytic treatment of patients with acute ischaemic stroke and is recommended by international treatment guidelines. Actilyse® was first approved in 1987 in major countries across the globe in the indication acute myocardial infarction, followed by subsequent approvals in the indications (acute) pulmonary embolism and acute ischaemic stroke (registered indications can vary across the globe). Actilyse® is registered in over 85 countries across the world and marketed outside North America and Japan by Boehringer Ingelheim.

About Boehringer Ingelheim: The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 42,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

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More information at:


1. Alteplase for treating acute ischaemic stroke. NICE Technology Appraisal 264. September 2012.

2. Rudd AG et al on behalf of the Intercollegiate Working Party for Stroke. Stroke thrombolysis in England, Wales and Northern Ireland: how much do we do and how much do we need? Journal of Neurology, Neurosurgery and Psychiatry 2011; 82: 14-19

3. Bembenek J et al. How many patients might receive thrombolytic therapy in the light of the ECASS-3 and IST-3 data? International Journal of Stroke. 2010; 5: 430


For further information and access to expert spokespeople:
Emma Keeling
020 8971 6415
George Hickling
020 8971 6406

Release Summary

NICE has issued final guidance on the use of alteplase for the treatment of acute ischaemic stroke, which recommends initiation of treatment within 4.5 hours of onset of ischaemic stroke symptoms.

Boehringer Ingelheim