Landmark Hunter study shows dramatic benefit of new stroke therapy

Mar 22 2012

Stroke trial patient Crystal Fitzgibbon with Associate Professor Mark Parsons.

A new clot-busting drug therapy has achieved significant treatment benefits for acute stroke victims in a groundbreaking three-year study by the HMRI Stroke Research Group.

Findings published today in the prestigious New England Journal of Medicine show two-thirds of patients treated with the drug Tenecteplase demonstrated major neurological improvement within 24 hours and 72 per cent experienced excellent or good recovery three months after their stroke.

Of those administered the standard drug Alteplase (tPA) during the trial from 2008-2011, only 36 per cent showed improvement at 24 hours and 44 per cent experienced good or excellent recovery after 90 days.

“These results took us by surprise. Treatment with Tenecteplase resulted in impressive benefits over the standard treatment with Alteplase,” study leader Associate Professor Mark Parsons from the University of Newcastle* said.

“With Alteplase we have seen a few dramatic outcomes but using a higher dosage of Tenecteplase there were some ‘Lazarus-like’ responses where the patient almost rose off the bed in a miraculous recovery.

“We saw patients severely affected by stroke returning to normal function within two or three days.”

Newcastle’s John Hunter Hospital was the co-ordinating centre, while Royal Melbourne and Box Hill hospitals in Victoria were also involved in the study.

The study used a rigorous selection criterion, with advanced CT perfusion imaging helping doctors identify patients mostly likely to benefit from clot-busting treatment. Almost 2,800 people presenting to hospital with acute stroke symptoms were screened for the study within six hours of onset – of these, 75 were enrolled.

Professor Chris Levi from Hunter New England Local Health District** said that while not all stroke patients benefited from clot-busting drugs, Tenecteplase was highly effective as part of a tailored treatment.

“Because stroke is such a hard illness to treat, any advance in treatment methods is like gold. Even if this treatment is only relevant to 10 per cent of patients, that is a huge improvement,” Professor Levi said.

“For every patient who undergoes tPA treatment there’s a significant cost saving … with Tenecteplase the savings may be even greater, though we need to investigate it more broadly.”

The study was funded by the National Health and Medical Research Council following initial grants from HMRI, which also funded previous CT imaging research integral in patient selection for this Tenecteplase trial.

The team is applying for additional funding to deliver a larger scale project with international partners to test if Tenecteplase is superior to Alteplase in the broader stroke patient population.

“If we are successful in our funding application, the project will be the largest ever clinical trial to be coordinated in the Hunter region,” Associate Professor Parsons said.

“We have to see if this drug benefits stroke patients in the ‘real world’ who may be less likely to experience the dramatic benefits seen in our current study but who, nonetheless, may still have some improvement.

“To prove that Tenecteplase is superior to Alteplase in the broader stroke patient population means we need a much larger study, which of course also requires more funding and large scale international collaboration.

“The future is looking very promising but we need to do a larger trial before we can have this treatment available for all acute stroke patients.”
HMRI is a partnership between the University of Newcastle, Hunter New England Health and the community.

* Associate Professor Mark Parsons works in the Faculty of Health at the University of Newcastle and is a Staff Specialist in Neurology at John Hunter Hospital.

** Professor Chris Levi is Director of the Acute Stroke Services at John Hunter Hospital and Director of the Priority Research Centre for Translational Neuroscience and Mental Health at the University of Newcastle.