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A study to evaluate the effectiveness of tenecteplase in patients with acute ischemic stroke who are more than 4.5 hours after their last known well time.

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Acute Ischemic Stroke, a condition that occurs when a blood vessel supplying the brain becomes blocked, preventing oxygen from reaching brain cells. The research aims to evaluate the effectiveness and safety of tenecteplase compared to the current standard medical treatments. This study is specifically looking at individuals who were last seen well more than 4.5 hours before receiving treatment, including cases known as wake-up stroke, where the exact time the symptoms started is unknown. This group includes people who show evidence through imaging, such as a computed tomography scan, that there is still salvageable brain tissue that can be saved if blood flow is restored.

During the trial, participants will receive either tenecteplase or the standard of care via an intravenous bolus, which is a method of delivering medication directly into a vein in a single quick dose. The study will monitor how well patients recover and function over a period of time, specifically looking at their ability to perform daily activities 90 days after the event. The researchers will also observe for any potential side effects, such as symptomatic intracranial hemorrhage, which is a type of bleeding inside the brain that can occur following treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Administration of medication

    A single dose of tenecteplase is given through an intravenous bolus, which is an injection delivered directly into a vein. the amount is 0.25 mg per kilogram of body weight, up to a maximum total dose of 25 mg.

  2. Step 2

    Neurological assessment

    An assessment of neurological improvement is conducted within the first 24 hours. this involves measuring changes in physical and cognitive functions using a standardized scale.

  3. Step 3

    Monitoring for complications

    The status of symptomatic intracranial hemorrhage, which is bleeding within the brain that causes symptoms, is monitored at 36 hours.

  4. Step 4

    Follow-up evaluation

    A final evaluation of functional outcome is performed at 90 days. this assessment measures the ability to perform daily activities and the overall level of independence.

Who can join the trial?

8 criteria

  • You must be a man or a woman who is at least 18 years old, or the legal age of adulthood in your country.
  • You must provide a signed and dated consent form, which is a written document where you agree to take part in the study.
  • You must have had an acute ischaemic stroke, which is a sudden blockage of blood flow to part of the brain that causes brain cells to die.
  • The stroke must be a wake-up stroke, which means the stroke happened while you were sleeping and was only discovered when you woke up.
  • The stroke must affect the supratentorial circulation, which refers to the upper part of the brain.
  • The time since you were last known to be healthy must be more than 4.5 hours before you are assigned to a treatment group.
  • Before the stroke, you must have had a modified Rankin Scale (mRS) score of 1 or less, which means you were able to function well and perform daily activities without significant help.
  • You must meet specific requirements based on imaging, which means doctors must see certain results on your MRI (a detailed scan using magnets) or CT scan (a scan using X-rays) to ensure you can participate.

Who cannot join the trial?

13 criteria

  • You cannot participate if you plan to undergo mechanical thrombectomy, which is a surgical procedure to remove a blood clot, at the same hospital where you start the study.
  • You are excluded if you have a history of damage to the central nervous system, which is the part of the body consisting of the brain and spinal cord, such as a neoplasm (a tumor or abnormal growth), an aneurysm (a weak or bulging spot in an artery wall), or malformations (abnormal developments) of the blood vessels.
  • You cannot join if you have had previous surgery on your brain or spine.
  • You are excluded if you have other medical conditions or health issues that increase your risk of bleeding outside of the brain.
  • You cannot participate if you have any medical reasons why you are not allowed to take tenecteplase, which is a medicine used to dissolve blood clots.
  • You are excluded if you have a blockage in the internal carotid artery, which is one of the main large blood vessels in the neck that supplies blood to the brain.
  • You cannot join if you are considered a high-risk patient, meaning you have a greater chance of experiencing a hemorrhage, which is bleeding inside the body, as a result of the treatment.
  • You are excluded if any scans of your brain, such as a non-contrast CT scan (an X-ray of the brain without special dye) or an MRI (a detailed image using magnets), show any signs of bleeding in the brain.
  • You cannot participate if you are unable to undergo brain imaging that uses contrast, which is a special dye used to make blood vessels and tissues easier to see on scans.
  • You are excluded if your stroke is considered severe based on a clinical scale called the NIHSS, which is a tool used by doctors to measure the seriousness of stroke symptoms.
  • You cannot join if your stroke symptoms are minor and do not cause significant disability, or if your symptoms are improving very quickly.
  • You are excluded if your brain scans or physical symptoms do not show an acute ischemic stroke, which is a stroke caused by a sudden blockage of blood flow to the brain, or if they suggest the stroke happened more than 72 hours ago.
  • You cannot participate if you are already scheduled to receive intravenous thrombolysis, which is the standard medical treatment of using medicine through a vein to break up a clot.
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Investigated drugs

Tenecteplase is a medication given through a vein that is used to help dissolve blood clots in the brain to help restore blood flow during an acute ischemic stroke.

What is already known about the treatment

Tenecteplase - This medication is an injectable liquid that is given directly into a vein as a single quick dose. It is a widely used drug in emergency medicine primarily used to dissolve blood clots that cause heart attacks or strokes. It works by targeting and breaking down the protein fibers that hold a blood clot together, effectively clearing the blockage to restore blood flow. This substance belongs to a class of drugs known as thrombolytics, or clot-busters.

Investigated diseases

Acute Ischemic Stroke - This condition occurs when a blood vessel supplying blood to the brain becomes blocked by a clot. The lack of blood flow prevents oxygen and nutrients from reaching brain cells. As a result, the affected brain cells begin to suffer damage and may die. The symptoms can appear suddenly depending on which part of the brain is affected. The progression of the damage is often linked to how quickly the blood flow is restored.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522542-40-00Protocol code1123-0060Estimated enrolment1 349 patientsSponsorBoehringer Ingelheim International GmbH

sourced from the EU Clinical Trials Register and site verification

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