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A Study of Tenecteplase for Acute Ischemic Stroke in Patients Taking Direct Oral Anticoagulants

Fast replyRegistered drugNo placebo
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What is this trial about?

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

This study examines acute ischemic stroke in patients who are taking direct oral anticoagulants, which are medications that help prevent blood clots. An acute ischemic stroke occurs when a blood vessel in the brain becomes blocked, preventing blood and oxygen from reaching brain tissue. The study will use tenecteplase, a medication that works by dissolving blood clots, or placebo. Tenecteplase is also known as Metalyse and will be given as a single dose through an injection into a vein. The purpose of the study is to find out whether treatment with tenecteplase improves recovery and functional ability after stroke in patients taking direct oral anticoagulants compared to placebo.

Patients in the study must have stroke symptoms that started within the past six hours, or in some cases with special imaging tests showing specific patterns in the brain, symptoms may have been present for a longer time or the exact time may be unknown. Before joining the study, patients will have brain imaging with either CT or MRI scans to make sure there is no bleeding in the brain. CT stands for computed tomography and MRI stands for magnetic resonance imaging, both of which are types of scans that create detailed pictures of the brain. Some patients may need additional specialized imaging tests that look at blood flow in the brain to check if they are suitable for the study.

During the study, patients will receive either tenecteplase or placebo as a single treatment. After treatment, doctors will monitor patients closely for any side effects, particularly any bleeding complications. The main assessment will occur ninety days after treatment, when doctors will evaluate how well patients have recovered and their ability to perform daily activities. Additional assessments will look at early improvement in stroke symptoms after twenty-four hours, quality of life, thinking abilities, and various safety measures including any bleeding events that may occur.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and imaging

    Upon joining the study, your medical team will confirm that you have experienced an acute ischemic stroke, which is a blockage of blood flow to the brain.

    Your stroke symptoms will be assessed using the National Institutes of Health Stroke Scale, a scoring system that measures the severity of stroke symptoms. Your score must be at least 2 points.

    A brain scan will be performed using either CT (computed tomography) or MRI (magnetic resonance imaging) to ensure there is no bleeding in your brain.

    The medical team will verify that you have taken a direct oral anticoagulant (a type of blood-thinning medication such as apixaban, rivaroxaban, edoxaban, or dabigatran) within the past 48 hours.

    If your stroke symptoms started more than 4.5 hours ago or the time of onset is unknown, additional specialized brain imaging may be required to determine if you are eligible for treatment.

  2. Step 2

    Treatment administration

    You will receive either tenecteplase or a placebo through an intravenous injection, which means the medication will be given directly into your vein.

    If you receive tenecteplase, the dose will be 0.25 mg per kilogram of your body weight, administered as a single injection.

    Tenecteplase is a medication designed to dissolve blood clots and restore blood flow to the brain.

    The placebo is an inactive substance that looks identical to the active medication but contains no active ingredients.

    Neither you nor your medical team will know which treatment you receive during the study.

  3. Step 3

    Monitoring within the first 4 hours

    After receiving the injection, you will be closely monitored for any side effects.

    The medical team will watch for signs of orolingual angioedema, which is swelling of the mouth, tongue, or throat that can occur within 4 hours of treatment.

  4. Step 4

    Assessment at 24 hours

    Approximately 24 hours after treatment, your neurological condition will be evaluated.

    The medical team will assess your stroke symptoms using the National Institutes of Health Stroke Scale to measure any changes in your condition.

  5. Step 5

    Monitoring within 36 hours

    During the first 36 hours after treatment, the medical team will monitor for any intracranial hemorrhage, which is bleeding inside the skull.

    This includes checking for symptomatic intracranial hemorrhage, which is bleeding that causes new neurological symptoms or worsening of existing symptoms.

  6. Step 6

    Monitoring within 72 hours

    Within the first 72 hours after treatment, you will be monitored for any major hemorrhage, which is significant bleeding anywhere in your body.

  7. Step 7

    Assessment at 30 days

    At 30 days after treatment, the medical team will evaluate whether any fatal bleeding in the brain has occurred.

  8. Step 8

    Final assessment at 90 days

    At 90 days after treatment, you will undergo a comprehensive evaluation of your recovery.

    Your functional outcome will be assessed using the modified Rankin Scale, which measures your level of disability and independence in daily activities. Scores range from 0 (no symptoms) to 6 (death).

    Your overall health-related quality of life will be evaluated using the PROMIS-10 questionnaire.

    Your cognitive function, including memory and thinking abilities, will be assessed using the Montreal Cognitive Assessment.

    The medical team will record any deaths that have occurred and the timing of such events.

Who can join the trial?

7 criteria

  • You must be 18 years of age or older
  • You must have a confirmed diagnosis of acute stroke, which is a sudden loss of blood flow to the brain, causing a disabling deficit, meaning symptoms that interfere with your daily activities
  • Your stroke severity score must be at least 2 on the NIHSS scale, which is a tool doctors use to measure how serious a stroke is by checking things like movement, speech, and vision
  • You must have taken a direct oral anticoagulant within the past 48 hours before joining the study. These are blood-thinning medications that help prevent blood clots, including apixaban, rivaroxaban, edoxaban, or dabigatran
  • A brain scan using CT or MRI, which are imaging tests that take pictures of your brain, must show no bleeding inside your skull. This scan must be done after your stroke started and no more than 60 minutes before you join the study
  • Your stroke symptoms must not have been present for more than 6 hours
  • If you were not awake and free of stroke symptoms within the past 4.5 hours, additional brain imaging tests are needed. These tests check if there is still brain tissue that can be saved by looking at the difference between damaged and at-risk areas of the brain

Who cannot join the trial?

3 criteria

  • The source data does not provide specific exclusion criteria, which are the reasons why a patient cannot participate in the study
  • Without detailed information about who cannot join this trial, it is not possible to list the specific conditions or situations that would prevent participation
  • Generally, clinical trials for stroke (a condition where blood flow to the brain is blocked) may exclude patients based on various medical factors, but these specific details are not available in the provided information
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Investigated drugs

  • Tenecteplase

    is a clot-busting medication given through a vein to help dissolve blood clots that cause stroke. It works by breaking down the clot that is blocking blood flow to the brain, which may help restore blood flow and reduce damage to brain tissue. In this trial, it is being tested to see if it can safely and effectively treat stroke in patients who are already taking blood-thinning medications.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active medicine. It is used in this trial to compare against tenecteplase so researchers can determine if tenecteplase truly provides benefit. Patients receiving placebo will get the same care and monitoring as those receiving the active medication, but without the clot-busting drug.

What is already known about the treatment

Tenecteplase – Tenecteplase is a medication given through an intravenous injection (directly into a vein) that is used to dissolve blood clots in patients experiencing acute ischemic stroke, which occurs when a blood vessel in the brain becomes blocked. This drug is a modified version of a natural protein in the body and works by breaking down fibrin, the main component that holds blood clots together, thereby restoring blood flow to the affected area of the brain. Tenecteplase belongs to a class of medications called thrombolytics or "clot-busters" and is currently being studied in clinical trials to evaluate its effectiveness and safety, particularly in patients who are taking blood-thinning medications called direct oral anticoagulants. The goal of using this medication is to quickly restore blood flow to the brain and improve recovery outcomes for stroke patients.

Investigated diseases

Acute Ischemic Stroke – Acute ischemic stroke occurs when blood flow to a part of the brain is suddenly blocked, usually by a blood clot in an artery. This blockage prevents oxygen and nutrients from reaching brain cells, causing them to become damaged or die within minutes. The condition typically develops suddenly and can affect various brain functions depending on which area is affected. Common signs include sudden weakness or numbness on one side of the body, difficulty speaking or understanding speech, vision problems, and loss of balance or coordination. The severity of symptoms can range from mild to severe, depending on the size and location of the blocked blood vessel. Without restoration of blood flow, the affected brain tissue continues to deteriorate, potentially leading to permanent loss of function in the affected areas.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521762-99-00Protocol codePASSIONEstimated enrolment668 patientsSponsorUniversity Medical Center Hamburg-Eppendorf

sourced from the EU Clinical Trials Register and site verification

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