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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

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 Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Hospital Foch	Suresnes	France
Fondation A De Rothschild	Paris	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Gbbkzi Hhvpltfjdee Uoimqueasjqzw Pculp Pckgfjfwqyx Es Nhtgbqlsuktt	Paris	France
Cfpzad Hdetwcvcmsl Eb Uphwnjaqtjfad Dn Lyxqglj	Limoges	France
Aopunwjznt Pkeqmlem Hsjdwspp Df Mphpnczjq	Marseille	France
Cytceq Hfheydksdzp Rnjtxbqr Ubvcaxkfpkhih Dp Trssv	Tours	France
Cixy Dv Nfagn	Vandoeuvre Les Nancy	France
Haulyaeb Uwtgatdmeegxcl Svnbslmhme &ivdkxl Haevqgr dl Hprmcyiyeqg	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	03.01.2023

Trial locations

Investigated drugs:

Glenzocimab

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.

Investigated diseases:

Ischaemic stroke

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 ID:

2024-514352-32-00

Protocol code:

APHP201028

NCT ID:

NCT05559398

Trial Phase:

Therapeutic use (Phase IV)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?