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Study on Glenzocimab for Patients with Acute Ischemic Stroke Undergoing Mechanical Thrombectomy

Fast replyInvestigationalNo placebo
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What is this trial about?

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

This clinical trial is focused on studying the effects of a treatment for acute ischemic stroke, a condition where blood flow to a part of the brain is blocked, leading to potential brain damage. The treatment being tested is called Glenzocimab, which is used in combination with a procedure known as mechanical thrombectomy. Mechanical thrombectomy is a method where doctors physically remove the blood clot from the brain's blood vessels. The study will compare the effects of Glenzocimab with a placebo, which is a substance with no active medication, to see if Glenzocimab improves recovery outcomes for patients.

The purpose of the study is to evaluate how effective Glenzocimab is when added to the standard treatment of mechanical thrombectomy. Participants in the study will receive either Glenzocimab or a placebo, in addition to the usual care. The study will monitor the participants' recovery over a period of 90 days to assess their functional outcomes, which refers to how well they can perform daily activities after the treatment. The study will also look at the safety of Glenzocimab by checking for any side effects or complications that may arise during the treatment period.

Throughout the study, participants will undergo various assessments, including brain imaging and neurological evaluations, to track their progress. These assessments will help determine the effectiveness of Glenzocimab in improving recovery from an acute ischemic stroke. The study aims to provide valuable information on whether adding Glenzocimab to the current treatment can lead to better outcomes for patients who have experienced a 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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and medical history.

    Informed consent is obtained, either directly from the patient or through a representative if the patient is unable to provide it.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the patient's condition and establish a baseline for the study.

    This includes imaging tests like magnetic resonance angiography (MRA) or computed tomography angiography (CTA) to confirm artery occlusion.

  3. Step 3

    Treatment administration

    The patient receives the study medication, glenzocimab, administered as a solution for infusion.

    The treatment is given in addition to standard mechanical thrombectomy procedures for acute ischemic stroke.

  4. Step 4

    Monitoring and follow-up

    The patient's progress is monitored closely, with assessments at 24 hours, 7 days or upon discharge, 30 days, and 90 days.

    Functional outcomes are evaluated using the modified Rankin Scale (mRS) at day 90, with additional assessments for neurological improvement and imaging results.

  5. Step 5

    Final evaluation

    At the end of the study period, a comprehensive evaluation is conducted to assess the efficacy and safety of the treatment.

    The primary focus is on the functional outcome at day 90, with secondary evaluations including survival rates and quality of life measures.

Who can join the trial?

8 criteria

  • Must be **18 years or older**.
  • Should not have any significant disability before the stroke. This means the person was mostly independent in daily activities.
  • Must be eligible for a treatment called **EVT** (Endovascular Therapy) within 0 to 24 hours after the stroke. This can be with or without another treatment called **intravenous thrombolysis**. The patient should have a specific type of stroke severity and brain scan results.
  • Must have a blockage in certain large blood vessels in the neck or brain, as seen on specific types of brain scans like **MRA** (Magnetic Resonance Angiography) or **CTA** (CT Angiography).
  • Must have signed an **informed consent** form. This means the patient agrees to participate in the study after understanding what it involves. If the patient cannot sign, a family member or trusted person can sign for them. In urgent situations, the patient can join the study, and consent will be obtained later when possible.
  • **Post-menopausal women** (women who haven't had a period for 12 months for reasons other than medical conditions) can participate. Women who can have children must use a very effective birth control method during the study and for at least 2 months after receiving the study medication.
  • Women who can have children must have a negative pregnancy test before starting the study. This includes women who have started having periods and are not yet post-menopausal unless they have had surgery to permanently prevent pregnancy.
  • Must be affiliated with social security or have any health insurance.

Who cannot join the trial?

7 criteria

  • Patients who have had a recent **acute ischemic stroke**. This is a type of stroke where a blood clot blocks or narrows an artery leading to the brain.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might have special needs or circumstances that require extra protection.
  • Patients who have medical conditions or are taking medications that could interfere with the study treatment or outcomes.
  • Patients who are unable to follow the study procedures or attend follow-up visits.
  • Patients who have participated in another clinical trial recently, which might affect the results of this study.
  • Patients who have any other condition that the study doctors believe would make it unsafe or inappropriate for them to participate.
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Investigated drugs

Glenzocimab is being studied as an additional treatment for patients who have had an acute ischemic stroke. It is used alongside a procedure called mechanical thrombectomy, which is a method to remove blood clots from the brain. The goal of using glenzocimab is to see if it can improve recovery and outcomes for patients when added to this procedure.

What is already known about the treatment

Glenzocimab – Glenzocimab is administered intravenously and is currently being studied in clinical trials as an add-on therapy for acute ischemic stroke. It is not yet widely used in medical practice, as it is still under investigation for its effectiveness and safety. The main therapeutic indication for glenzocimab is to improve outcomes in patients undergoing mechanical thrombectomy, a procedure to remove blood clots from the brain. At the molecular level, glenzocimab works by inhibiting platelet aggregation, which helps prevent further clot formation. It is classified pharmacologically as an antiplatelet agent.

Investigated diseases

Acute Ischemic Stroke – This condition occurs when a blood clot blocks or narrows an artery leading to the brain, resulting in reduced blood flow and oxygen to brain tissue. The lack of oxygen causes brain cells to begin dying within minutes. Symptoms can include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, or difficulty understanding speech. As the condition progresses, it may lead to further neurological impairments, depending on the area of the brain affected. Immediate medical attention is crucial to minimize brain damage and potential complications. The progression and severity of symptoms can vary widely among individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-514352-32-00Protocol codeAPHP201028Estimated enrolment260 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).