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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Centre Hospitalier Universitaire Rouen Rouen France
Hopitaux Universitaires Pitie Salpetriere Paris France
Hospital Foch Suresnes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre Hospitalier De Perpignan Perpignan France
Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis Aix En Provence France
Centre Hospitalier General Gonesse France
Fondation A De Rothschild Paris France
Centre Hospitalier Sud Francilien Corbeil Essonnes France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Centre Hospitalier De Saint-Denis St Denis France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
04.05.2026

Trial locations

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.

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 ID:
2024-520414-21-00
Protocol code:
APHP240911
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • A Study of TGD001 in Patients with Acute Ischemic Stroke to Test Safety and Effectiveness

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    Germany Poland Spain
  • A study testing tenecteplase given directly into the artery after blood clot removal in patients with acute ischemic stroke in the front part of the brain

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    Investigated diseases:
    Investigated drugs:
    Germany