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Comparing tenecteplase and mechanical clot removal versus mechanical clot removal alone for adults with a large ischemic stroke

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 experiencing a large ischemic stroke, which is a type of brain attack that occurs when a blood vessel in the brain is blocked by a clot. A specific type of this condition being investigated is a large vessel occlusion stroke, where a major artery in the brain is shut by a blockage. The purpose of the study is to compare two different ways of treating this condition to see which one leads to better physical recovery after three months.

One treatment approach involves thrombectomy, a procedure where doctors use specialized tools to physically remove the clot from the blocked artery. The other approach combines this procedure with intravenous thrombolysis, which is the administration of a clot-dissolving medication through a vein. In this study, the medication used for this process is tenecteplase. Participants will be assigned to receive either the combination of the medication and the procedure or just the procedure alone.

During the study, the effectiveness of the treatments will be observed by monitoring how well patients can perform daily activities and move independently. Doctors will also use imaging techniques like diffusion weighted imaging and fluid attenuated inversion recovery, which are special types of MRI scans used to look at the brain, to evaluate the extent of the brain injury. Safety will be monitored closely to check for any complications such as intracranial hemorrhage, which is bleeding inside the skull.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment assignment

    You are assigned to one of two treatment groups to compare different ways of treating a large ischemic stroke, which is a type of stroke caused by a blockage in a blood vessel in the brain.

    The first group receives tenecteplase, which is a medicine given through an intravenous bolus (a single injection directly into a vein), followed by a thrombectomy (a procedure to remove the blood clot from the brain). the dose of tenecteplase is 25 mg.

    The second group receives only the thrombectomy procedure to remove the blood clot without the initial injection of tenecteplase.

  2. Step 2

    Follow-up and assessment

    Your recovery is monitored through various assessments to track neurological improvement, which refers to how well your brain functions.

    At day 1, evaluations are made regarding infarct volume (the size of the area of brain tissue damaged by the stroke) and neurological scores to check for any worsening of symptoms.

    At 3 months, an interview is conducted in person or by telephone to determine your functional outcome. this is measured by your ability to move independently, known as independent ambulation.

    At 1 year, further assessments are conducted to check for continued functional independence and your ability to walk without assistance.

Who can join the trial?

7 criteria

  • You must be at least 18 years old.
  • Before having a stroke (a sudden interruption of blood flow to the brain), you must have had a high level of independence, meaning you could perform daily activities without help, which is measured by a score called mRS (modified Rankin Scale) of 1 or less.
  • The stroke must have occurred in the anterior circulation, which refers to the blood vessels that supply the front part of the brain.
  • The stroke must be a Large Vessel Occlusion (LVO), which means a major artery in the brain is blocked.
  • You must be able to receive a thrombectomy (a procedure to manually remove the blood clot from the artery) within 24 hours of the stroke starting, or if the exact time is unknown, you must show a DWI-FLAIR mismatch (a specific pattern seen on brain scans that helps doctors identify recent brain damage).
  • The stroke must involve a large core, which means a significant area of brain tissue has already been damaged. This is determined by specific scores on brain imaging, such as ASPECTS (a scoring system used to evaluate the extent of a stroke on a scan) or the volume of the damaged area measured in milliliters.
  • You or a trusted person, such as a family member or close relative, must provide written informed consent, which is a formal document stating you understand and agree to take part in the study. In emergency situations, this can be provided as soon as possible.

Who cannot join the trial?

13 criteria

  • You have a stroke in the posterior circulation, which is the part of the brain that supplies blood to the back of the head and the brainstem.
  • You have a stroke in the anterior circulation (the front part of the brain) where the blockage is too far away from the main vessels to be treated by thrombectomy, which is a procedure to physically remove a blood clot.
  • You are currently pregnant or breastfeeding.
  • You have any medical reason that prevents you from receiving intravenous thrombolysis, which is a treatment using medicine through a vein to dissolve blood clots. This includes:
    • Being unable to lower your blood pressure below 185/110 mmHg.
    • Having respiratory failure (difficulty breathing) or hemodynamic failure (unstable blood flow or blood pressure).
    • Having active external bleeding (bleeding outside of the body).
    • You have any reason that prevents you from undergoing a thrombectomy, such as:
      • Being unable to have an arterial puncture, which is a procedure where a needle is inserted into an artery in the groin (femoral), wrist (radial), or upper arm (humeral).
      • Having an allergy to iodinated contrast media, which is a special dye used during imaging tests to make blood vessels easier to see.
      • Having renal insufficiency, which means your kidneys are not working well enough, specifically if your creatinine clearance (a measure of how well your kidneys filter waste) is less than 30 ml/min.
      • Your doctors expect your life expectancy to be less than 3 months.
      • You are already participating in another clinical trial involving a medical product or a randomized study.
      • You are not covered by the French national social security system.
      • You are under legal protection (such as a tutor or curator) and are deprived of your freedom.
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Investigated drugs

  • Tenecteplase

    is a medication given through a vein that works by helping to dissolve the blood clot blocking blood flow to the brain during a stroke.

  • Thrombectomy

    is a medical procedure where doctors use specialized tools to physically remove a blood clot from an artery to restore blood flow.

What is already known about the treatment

Tenecteplase - This medication is a specialized liquid medicine given through a single quick injection into a vein. It is a widely used treatment in emergency medicine designed to help dissolve dangerous blood clots that block blood flow. At a molecular level, it works by targeting and breaking down the proteins that hold a blood clot together, effectively melting the blockage. This drug belongs to a class of medicines known as thrombolytics, which are commonly used to treat patients experiencing a large stroke.

Investigated diseases

Large vessel occlusion stroke - This condition occurs when a major artery in the brain becomes blocked, preventing blood from reaching vital areas. As the blockage persists, the lack of blood flow leads to the death of brain cells in the affected region. The size of the damaged area, often called the infarct core, can increase if the blockage is not resolved. This process typically causes sudden neurological deficits depending on which part of the brain is affected.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520414-21-00Protocol codeAPHP240911Estimated enrolment486 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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