TARDIS trial seeks new dimension in stroke treatment

October 17, 2011, University of Nottingham

People who suffer from acute stroke or Transient Ischaemic Attack (TIA, a mini stroke) could get better treatment in the future thanks to the expansion of a large clinical trial of a new combination of drugs led by researchers at The University of Nottingham.

The TARDIS trial is testing the safety, tolerability and effectiveness of an intensive blood thinning therapy involving a combination of three drugs instead of the one or two that are normally prescribed.

The scientists have recruited more than 550 patients with stroke or TIA from across the UK but now hope to expand the trial to include up to 4,200 patients from around the world. They believe that by using three anti-platelet drugs (the combination of aspirin, clopidogrel and ) instead of the one or two currently used now, the effects of the stroke and chances of recurrence could be greatly reduced.

Strokes happen when the blood supply to part of the brain is cut off by a blood clot or other blockage. Around 150,000 people have a stroke in the UK every year. Stroke patients occupy a fifth of acute hospital beds and a quarter of long-term beds. For about a third of the the attack proves fatal and many more are left severely disabled.

TARDIS stands for Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke. The trial is a randomised, parallel-group in which, within 48 hours of a stroke or TIA, half the patients recruited are given the 3-drug combination for one month. The other half receives the existing guideline antiplatelet therapy. Both groups are monitored for 90 days for frequency and severity of by observers who do not know which treatment the patient has been on.

The major risk of taking an extra antiplatelet drug is the possibility of causing extra bleeding, such as bruising on the skin, into the gut or bleeding into the brain. But the scientists believe the potential benefit of a reduced chance of having another stroke will outweigh the risk of further bleeding.

Chief investigator, Professor Philip Bath from the University’s School of Clinical Sciences said: “We believe this trial will be hugely significant in finding a better treatment for stroke and TIA to minimise the effects and the risk of recurrence in . We are going to be able to compare the frequency and severity of recurrent cerebrovascular events in both sets of patients; data which will be invaluable in stroke medicine worldwide.”

The initial UK phase of the TARDIS trial has been funded by the British Heart Foundation through the University’s Division of Stroke Medicine. Now the researchers are seeking funding to expand the trial to include 4,200 new patients from across the world over the next five years.

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