Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis 2
Research type
Research Study
Full title
Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis 2
IRAS ID
199347
Contact name
Keith Muir
Contact email
Sponsor organisation
NHS Greater Glasgow & Clyde
Eudract number
2016-002075-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 3 months, 29 days
Research summary
"Clot busting" (thrombolytic) drug treatment given in the first few hours after onset of stroke caused by a blockage in a blood vessel in the brain greatly improves the chances of recovering to independence. Treatment is effective for patients of all ages and severities of stroke. The quicker treatment can be given, the greater the benefit. Stroke units in the UK now treat up to 20% of stroke patients with thrombolytic drugs.
However, it may be possible to improve upon the drug that is currently used (alteplase, also known as rtPA). Newer clot busting drugs have been developed, and have replaced alteplase in other fields of medicine. We, and others, have investigated one of these drugs, called tenecteplase, in small studies in stroke patients, and it appears possible that tenecteplase is potentially more effective and also safer than alteplase, causing less disruption of the body's blood clotting system, and possibly fewer brain haemorrhages.
We now wish to test tenecteplase in a large clinical trial to establish whether it is better than alteplase. This will involve a large number of hospitals in the UK, and possibly overseas. People who are considered suitable for clot busting treatment will be allocated at random to receive either the current standard treatment with alteplase, or tenecteplase, and will be followed up for the first 90 days to measure the effects on recovery.
Even if there are no significant differences between tenecteplase and alteplase, tenecteplase is less expensive and much easier to give (needing a single injection only, whereas alteplase has to be given as an injection followed by a longer injection over an hour). This alone would have worthwhile benefits.
REC name
Scotland A: Adults with Incapacity only
REC reference
16/SS/0137
Date of REC Opinion
2 Sep 2016
REC opinion
Favourable Opinion