Tenecteplase for the treatment of acute stroke in the late time window before inter-hospital transfer for thrombectomy: a randomized controlled trial
An ischaemic stroke happens when a blood clot blocks blood flow to part of the brain. Some patients need to be transferred to a specialist hospital for a procedure called a thrombectomy to remove the clot. This clinical trial is testing a clot-busting medicine called tenecteplase (Metalyse). Researchers want to see if giving tenecteplase before transfer helps clear the blockage faster and improves recovery. Patients in this study are treated in an emergency setting. Their recovery is assessed after 24 to 36 hours with brain scans and check-ups. Around 90 days later, researchers contact the patient or their carer by telephone to see how well they can carry out daily activities. The study will show whether this treatment leads to better long-term independence without causing harmful side effects.
At a glance
What is this study about?
A stroke is a medical emergency that occurs when the blood supply to part of the brain is cut off, usually by a blood clot. Quick treatment is vital to save brain tissue. For severe strokes caused by large clots, patients often need a procedure called a mechanical thrombectomy, where a doctor physically removes the clot using a tiny device. However, not every local hospital can perform this procedure, meaning patients often need an urgent transfer to a specialist hospital.
This trial is looking at whether giving a fast-acting clot-busting injection called tenecteplase before the transfer can improve outcomes. Tenecteplase works by dissolving blood clots to restore blood flow as quickly as possible. Researchers are focusing particularly on people who arrive at hospital in a later time window after their stroke symptoms began, to find out if they can still benefit safely from this drug.
By comparing patients who receive the treatment to standard care, doctors hope to learn if tenecteplase helps clear clots earlier and reduces brain damage during transfer. If successful, this approach could improve physical recovery, help more stroke survivors regain their independence, and change how emergency stroke care is delivered across hospitals.
Key takeaways
- Tests a clot-busting injection (tenecteplase) for ischaemic stroke.
- Aimed at patients needing an ambulance transfer to a specialist hospital for clot-removal surgery.
- Studies whether earlier treatment improves recovery for patients arriving in later time windows.
- Recovery and daily independence are checked by phone 90 days after treatment.
- Carried out in hospital emergency departments under close medical supervision.
Who may be eligible?
This trial is designed for adults aged 18 and older who are having an acute ischaemic stroke caused by a blocked blood vessel. Because this is an emergency study, participants are identified immediately upon arrival at the hospital emergency department.
To be considered, patients must be candidates for a mechanical thrombectomy and need an inter-hospital transfer to a specialist stroke centre. They also fall into what doctors call a 'late time window', meaning a few hours have passed since their symptoms started or they woke up with stroke symptoms.
People who have a bleeding stroke (haemorrhagic stroke) or who have an unusually high risk of dangerous bleeding cannot take part. The hospital stroke team will rapidly review brain scans to confirm whether this treatment is safe and suitable for the individual.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Aged 18 years or older.
- Diagnosed with an acute ischaemic stroke (caused by a blood clot).
- Needs transfer to a specialist hospital for mechanical clot removal (thrombectomy).
- Arrived at hospital within the extended or later time window after stroke symptoms began.
- Has brain scans showing it is safe to receive clot-dissolving medication.
What does participation involve?
Because stroke care is an emergency, joining the study happens straight away in the hospital. If eligible, the patient receives tenecteplase as a quick injection into a vein before being moved by ambulance to the specialist hospital for their clot-removal procedure. During the first day or two, the medical team will carry out brain scans and standard stroke assessments to check blood flow and brain recovery. After leaving the hospital, the total study follow-up lasts around 90 days. At the end of the three months, a researcher will hold a phone interview with the patient or their family to ask about everyday abilities and quality of life.
Potential risks and benefits
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Common questions
What is tenecteplase?
Tenecteplase is an established clot-busting medicine given by a single injection into a vein to dissolve dangerous blood clots.
What is a thrombectomy?
A thrombectomy is an emergency procedure where a specialist doctor threads a thin tube through a blood vessel to pull out a clot blocking blood to the brain.
Will taking part delay my transfer or emergency care?
No. The injection is given quickly and is designed to fit directly into the standard emergency transfer process without causing harmful delays.
How can I give consent if I am very unwell from the stroke?
In emergency stroke research, strict ethical rules allow doctors to enrol patients if a family member agrees, or under emergency research permissions if the patient cannot communicate, with consent sought as soon as possible later.
Do I have to travel back to the hospital for follow-up visits?
No. The main 90-day check-up is conducted simply over the telephone with you or your caregiver.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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