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Study of alteplase and tenecteplase for intravenous thrombolysis in patients with ischemic stroke who are taking direct oral anticoagulants

Verified siteRegistered 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 focuses on patients with acute ischemic stroke who are taking direct oral anticoagulants. An ischemic stroke occurs when a blood clot blocks blood flow to part of the brain. The study examines two medications used for dissolving blood clots: alteplase and tenecteplase, which are given through an intravenous injection into a vein.

The purpose of this research is to determine if using these clot-dissolving medications leads to better recovery in stroke patients who are already taking blood-thinning medicines. The medications will be compared to standard care treatment to see if they can improve patients' ability to perform daily activities after their stroke.

During the study, participants will receive either one of the clot-dissolving medications or standard care treatment. The treatment must be given within 4.5 hours of when stroke symptoms begin. Doctors will monitor patients' recovery and check for any bleeding complications. Follow-up assessments will be conducted over 90 days to evaluate how well patients recover from their stroke.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and treatment

    After experiencing symptoms of ischemic stroke and having taken blood-thinning medication within the last 48 hours, you will receive an assessment to determine eligibility for treatment.

    If eligible, you will receive one of two medications through an intravenous injection (directly into your vein): either alteplase or tenecteplase.

    Treatment must begin within 4 hours and 30 minutes of the last time you were known to be well, or within 4.5 hours if specific brain imaging criteria are met.

  2. Step 2

    24-hour evaluation

    After approximately 24 hours (±12 hours), you will undergo an assessment of your stroke severity.

    The medical team will check for any potential bleeding complications.

    Brain imaging may be performed to measure the size of the affected area.

  3. Step 3

    36-hour safety check

    The medical team will monitor for any signs of bleeding in the brain during the first 36 hours after treatment.

  4. Step 4

    7-day follow-up

    Your condition will be monitored for up to 7 days or until hospital discharge.

    The medical team will record any significant health events during this period.

  5. Step 5

    90-day final assessment

    A final evaluation will take place approximately 90 days (±2 weeks) after treatment.

    This assessment will include checking your level of independence in daily activities.

    You will complete a quality of life questionnaire to evaluate your overall well-being.

Who can join the trial?

7 criteria

  • Patient must provide informed consent to participate in the study (in some cases, consent may be obtained later as allowed by national law)
  • Patient must have an acute ischemic stroke (a type of stroke caused by blocked blood flow to the brain) that qualifies for treatment with clot-dissolving medications according to the doctor's assessment
  • Patient must have taken direct oral anticoagulants (blood-thinning medications) within the last 48 hours, or be currently prescribed these medications even if exact time of last dose is unknown
  • Patient must meet ONE of these timing requirements:
    • Can start treatment within 4 hours and 30 minutes from when symptoms began, OR
    • Have specific brain MRI findings showing signs of a recent stroke (within 4.5 hours) and can start treatment within 4.5 hours of when symptoms were first noticed
    • Both men and women can participate in the study
    • Adults of all ages can participate

Who cannot join the trial?

13 criteria

  • Patient age below 18 years or above 85 years
  • Patients who have not taken direct oral anticoagulants (blood-thinning medications) recently
  • Patients who have conditions other than acute ischemic stroke (blocked blood flow to the brain)
  • Patients who are not eligible for intravenous thrombolysis (clot-dissolving treatment) according to local care standards
  • Patients unable to provide informed consent
  • Patients who cannot be followed up for 90 days after treatment
  • Patients currently participating in other clinical trials
  • Patients with severe kidney or liver disease
  • Patients with active bleeding
  • Patients with a history of brain hemorrhage
  • Patients with blood pressure that cannot be controlled to acceptable levels
  • Pregnancy or breastfeeding
  • Known allergy to the study medications (alteplase or tenecteplase)
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Investigated drugs

  • Alteplase

    is a clot-busting medication that helps restore blood flow to the brain during an acute ischemic stroke. It works by breaking down blood clots that are blocking blood vessels. This medication is given through an intravenous (IV) line.

  • Tenecteplase

    is also a clot-dissolving medication used to treat ischemic stroke. Like alteplase, it works by breaking down blood clots, but it can be given as a single injection. It's designed to be more specific to fibrin (the main component of blood clots) than alteplase.

  • Direct Oral Anticoagulants (DOACs)

    are blood-thinning medications that help prevent blood clots from forming. These medications are taken by mouth and work by interfering with specific proteins in the blood that are involved in clot formation. They are commonly used to prevent strokes in patients with certain heart conditions.

What is already known about the treatment

  • Alteplase

    A clot-dissolving medication administered intravenously to treat acute ischemic stroke, working by breaking down blood clots that block blood flow to the brain. This enzyme-based drug belongs to the tissue plasminogen activator (tPA) class and is currently a standard treatment in emergency stroke care, particularly effective when given within the first few hours after stroke symptoms begin. The medication works by converting plasminogen to plasmin, which then breaks down fibrin clots in the bloodstream.

  • Tenecteplase

    A modified version of tissue plasminogen activator (tPA) given as a single intravenous bolus for treating acute ischemic stroke, offering potentially improved clot-dissolving properties compared to alteplase. This medication belongs to the thrombolytic drug class and has shown promising results in clinical trials for stroke treatment, with the advantage of a simpler dosing regimen. It functions by specifically binding to fibrin in blood clots and converting plasminogen to plasmin, leading to clot dissolution.

Investigated diseases

Acute Ischemic Stroke - A condition that occurs when blood flow to an area of the brain is blocked by a clot, preventing brain tissue from getting oxygen and nutrients. The blockage causes brain cells to begin dying within minutes. This condition develops suddenly and can affect different areas of the brain, leading to various neurological symptoms such as weakness on one side of the body, speech problems, or vision disturbances. The severity of symptoms depends on the location and size of the blocked area in the brain.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515561-34-01Protocol codeDO-ITEstimated enrolment655 patientsSponsorInsel Gruppe AG

sourced from the EU Clinical Trials Register and site verification

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