TENACITY – A Phase III, prospective, randomized, open-label, blinded endpoint assessment (PROBE) to assess efficacy and safety of i.v. tenecteplase vs standard of care in patients with acute ischemic stroke (including wake-up stroke), last known well >4.5 h with imaging evidence of salvageable ischemic tissue
This study, called TENACITY, is for adults who have had a type of stroke caused by a blood clot, known as an acute ischaemic stroke. This includes people who wake up with stroke symptoms or whose stroke means they receive treatment more than 4.5 hours after symptoms started. Doctors want to see if a medicine called tenecteplase works better and is as safe as the standard treatment. They will be looking at how well people recover after 90 days, specifically if they can live independently and do everyday activities. This study is in its final stage of testing, meaning it's comparing the new treatment against current best practice.
At a glance
What is this study about?
This medical study, known as TENACITY, is focused on improving treatment for a kind of stroke called an ischaemic stroke. This happens when a blood clot blocks blood flow to the brain. Sometimes, people have these strokes while they're asleep and only notice symptoms when they wake up, or they might not get to the hospital within the usual treatment window. For these patients, and others treated more than 4.5 hours after their symptoms started, doctors want to find better ways to help them recover.
The study is comparing a drug called tenecteplase (also known as Metalyse) with the standard treatment currently given. Doctors believe tenecteplase might be a good option because scans can show if parts of the brain affected by the stroke might still be saved. The main goal is to see if people treated with tenecteplase have a better chance of making a good recovery and living independently 90 days after their stroke.
This is a 'Phase III' study, which means it's one of the last steps before a new treatment might become widely available. Researchers are carefully checking how well the drug works and if it's safe for patients. The information from this study will help decide if tenecteplase could become a new standard treatment for certain stroke patients in the future.
Key takeaways
- Tests a new stroke drug (tenecteplase) for ischaemic stroke.
- Aims to improve recovery for people treated after 4.5 hours or with 'wake-up strokes'.
- Compares tenecteplase against current standard stroke treatment.
- Main measurement is how well people recover and live independently 90 days after stroke.
- Involves regular health checks and assessments of your recovery.
Who may be eligible?
To be considered for this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.
The most important physical requirement is that you must have recently had an ischaemic stroke – that's a stroke caused by a blood clot. This includes situations where you woke up with stroke symptoms (a 'wake-up stroke') or if more than 4.5 hours have passed since your stroke symptoms started, but doctors can see on a scan that some of your brain tissue could still be saved.
Doctors will also consider other health factors and test results to make sure it's safe for you to take part. This ensures the study includes people who are most likely to benefit from the treatment and for whom it's appropriate.
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.
- Are you 18 years old or older?
- Have you recently had a stroke caused by a blood clot (ischaemic stroke)?
- Did your stroke symptoms start more than 4.5 hours ago, or did you wake up with them?
- Do doctors see on your scans that some brain tissue might still be saved?
- Are you able to provide consent (or can a legal representative provide it for you)?
What does participation involve?
If you decide to take part in this study, you would be given either the study drug, tenecteplase, or the usual care treatment for your stroke. The study drug is given as a single injection into your vein.
Throughout the study, doctors and nurses would regularly check on your health and your stroke symptoms. They would do assessments to see how well you are recovering, especially within the first day and again after 90 days. This involves questions and simple tests to check your movement, speech, and ability to do daily tasks.
There would be several follow-up appointments to monitor your progress and safety. The main follow-up for the study's purpose is at 90 days after your stroke, where doctors will check your level of recovery. The total duration of your active participation in the study, including treatment and assessments, would involve this 90-day period.
Potential risks and benefits
Locations (6)
- —UnverifiedGreece
- —UnverifiedNorway
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- —UnverifiedSpain
- —UnverifiedBulgaria
Common questions
What kind of stroke is this study for?
This study is for ischaemic stroke, which is caused by a blood clot blocking blood flow to your brain.
What is tenecteplase (Metalyse)?
It's a medicine given by injection that helps to dissolve blood clots.
What does 'wake-up stroke' mean?
It means you had stroke symptoms when you woke up, but you don't know exactly when they started during your sleep.
How long will I be followed up in the study?
The main follow-up for recovery is at 90 days after your stroke.
Will I know if I'm getting the study drug or standard care?
No, this is an 'open-label' study, but some of the assessments of your recovery will be done by people who don't know which treatment you received.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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