Tenecteplase in Wake-up Ischaemic Stroke Trial
Research type
Research Study
Full title
Tenecteplase in Wake-up Ischaemic Stroke Trial (TWIST)
IRAS ID
202096
Contact name
Thompson Robinson
Contact email
Sponsor organisation
University Hospital North Norway
Eudract number
2014-000096-80
ISRCTN Number
ISRCTN10601890
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Stroke is a leading cause of death and disability. The clot-busting drug, alteplase, is the only approved drug treatment for acute ischaemic stroke, but must be given within 4.5 hours of symptom onset. Unfortunately, at least 20% of patients currently wake-up with their stroke symptoms, so-called ‘wake up stroke’. These patients are currently ineligible for clot-busting therapy, though it is likely that their stroke happened just before awakening. This study proposes to randomise ‘wake up’ stroke patients to usual care or usual care plus clot-busting drug, after a scan to exclude bleeding or significant brain damage that has already resulted from the stroke. We propose to use a CT scan to inform this decision, which all patients with stroke have on coming into hospital. Other studies testing clot-busting treatment in ‘wake up’ stroke are using more complex brain scans, which can delay treatment and are not routinely available in the emergency situation in all hospitals. Thus, the result of our study is more likely to help more UK patients with ‘wake up’ stroke. In addition, we will be using the newer clot-busting drug, tenecteplase, which is likely to be more effective in improving blood supply to the brain more quickly, so promoting better recovery.
Patients taking part will have the results of all their routine tests recorded, and have additional assessments of their recovery at 7 days after stroke (or hospital discharge) and at 3 months. These are intended to assess whether this treatment in ‘wake up’ stroke improves outcome and is safe. It is hoped that altogether 500 patients will take part around the world; 200 in the UK. We hope (and expect) that the study will result in better long-term outcome for the 20% of patients who currently are excluded from clot-busting therapy, because they wake up with their stroke.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
16/EM/0322
Date of REC Opinion
13 Oct 2016
REC opinion
Further Information Favourable Opinion