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Study on Intra-Arterial Thrombolysis with Alteplase for Patients with Acute Ischemic Stroke in the Anterior Circulation

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 clinical trial is focused on studying a condition known as ischemic stroke, which occurs when a blood clot blocks a blood vessel in the brain, leading to reduced blood flow and potential brain damage. The study is investigating a treatment called intra-arterial thrombolysis, which involves delivering medication directly into the arteries to dissolve clots. The medication used in this study is called Actilyse, which contains the active substance alteplase. This treatment is being compared to not using the additional intra-arterial thrombolysis after a successful initial treatment to see if it improves recovery outcomes.

The purpose of the study is to determine if adding intra-arterial thrombolysis can lead to better recovery in patients who have already had a successful initial treatment for their stroke. Participants in the study will receive either the additional treatment with Actilyse or no additional treatment after their initial stroke treatment. The study will monitor participants over a period of 90 days to assess their recovery and any changes in their ability to perform daily activities. The study aims to see if the additional treatment can help improve the overall recovery and reduce disability caused by the stroke.

Throughout the study, participants will undergo various assessments to track their progress. These assessments will include evaluations of their neurological function and overall health. The study will also monitor for any potential side effects or complications related to the treatment. The results of this study could provide valuable information on the effectiveness of intra-arterial thrombolysis in improving outcomes for patients who have experienced an ischemic stroke.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria. These include having a pre-stroke modified Rankin Scale (mRS) score of 0-2, experiencing an acute ischemic stroke with a blockage in the anterior circulation, and having a National Institutes of Health Stroke Scale (NIHSS) score of 5 or higher at admission.
Successful angiographic reperfusion must be confirmed through a catheter angiogram, showing eTICI scores of 2b, 2c, or 3 after initial treatments.
Step 2
Treatment phase
The treatment involves the use of alteplase, administered intra-arterially. This medication is provided as a solution for injection or infusion.
The objective is to assess the effectiveness of additional intra-arterial thrombolysis compared to no additional treatment, focusing on improving the 90-day functional outcome.
Step 3
Monitoring and follow-up
The primary endpoint is evaluated by measuring the severity of disability using the modified Rankin Scale (mRS) at 90 days, with a margin of 15 days.
Secondary endpoints include assessing early neurological improvement within 24 hours, complications during treatment, and any hemorrhages within 24 hours. The study also evaluates the cost-effectiveness of the treatment strategy.
Step 4
Completion of the study
The study is expected to conclude by September 30, 2028. The final assessments will include a comprehensive evaluation of the treatment's impact on health outcomes and costs.

Who can join the trial?

8 criteria

The patient must have had a **stroke** caused by a blockage in the blood vessels in the brain, known as an **ischemic stroke**.
Before the stroke, the patient should have been able to perform daily activities with little or no help, as measured by a score of 0 to 2 on the **modified Rankin Scale (mRS)**, which is a tool used to measure the degree of disability or dependence in daily activities.
The stroke must be in the **anterior circulation**, which includes certain major blood vessels in the brain, and must be confirmed by a **CT** or **MRI** scan. These are imaging tests that help doctors see inside the body.
The patient must have a **NIHSS score** of 5 or higher when admitted to the hospital. The **NIHSS** is a scale used to measure the severity of a stroke.
The patient must have achieved a certain level of blood flow restoration in the brain, known as **eTICI 2b-2c-3**, after receiving one of the following treatments: **IVT alone** (intravenous thrombolysis), **bridging therapy** (a combination of IVT and mechanical thrombectomy), or **MT alone** (mechanical thrombectomy). This must be confirmed by a **catheter angiogram**, which is a special X-ray test that shows blood flow in the brain.
The patient must be between the ages of 18 and 85.
Both male and female patients are eligible to participate.
The study may include individuals who are considered part of a vulnerable population, which means they might need special protection or consideration.

Who cannot join the trial?

7 criteria

Patients who have not experienced an ischemic stroke. An ischemic stroke happens when a blood vessel supplying blood to the brain is blocked.
Patients who do not have a condition called acute anterior circulation LVO stroke. This is a type of stroke that affects the front part of the brain due to a large blood vessel being blocked.
Patients who have not achieved successful angiographic reperfusion. This means that the blood flow in the brain has not been successfully restored after treatment.
Patients who are not within the specified age range for the study. The study has specific age requirements that participants must meet.
Patients who are not part of the specified clinical trial groups. The study is looking for participants who fit certain group criteria.
Patients who are not male or female. The study includes both male and female participants.
Patients who are not considered part of a vulnerable population. This refers to groups of people who might need special protection or consideration in a study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Besancon University Hospital Center
Verified
Besançon, France
CHRU De Nancy
Responsive
Vandoeuvre Les Nancy, France
CHU Grenoble Alpes
Verified
La Tronche, France

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Investigated drugs

Intra-Arterial Thrombolysis is a treatment used in this clinical trial. It involves delivering medication directly into the arteries to dissolve blood clots. This therapy is being tested to see if it can improve recovery in patients who have had a stroke caused by a blockage in a large blood vessel in the brain. The goal is to see if this treatment can lead to better outcomes for patients 90 days after their stroke.

Alteplase

What is already known about the treatment

Thrombolytic Agent – This medication is administered intra-arterially, meaning it is delivered directly into the arteries. It is currently being studied in clinical trials for its effectiveness in treating ischemic stroke, particularly in cases involving large vessel occlusion in the anterior circulation. The main therapeutic indication is to improve functional outcomes in stroke patients by enhancing blood flow after successful angiographic reperfusion. At the molecular level, it works by breaking down blood clots, thereby restoring blood flow to the affected area of the brain. It is classified pharmacologically as a thrombolytic agent, which is a type of medication used to dissolve clots and improve circulation.

Investigated diseases

Ischemic Stroke – Ischemic stroke occurs when a blood clot blocks or narrows an artery leading to the brain, resulting in reduced blood flow and oxygen to brain tissue. This blockage can cause brain cells to begin dying within minutes, leading to potential loss of function in the affected area. Symptoms may include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, or difficulty seeing. The progression of the disease can vary, with some individuals experiencing rapid recovery, while others may have lasting impairments. The severity and location of the blockage often determine the extent of the damage. Immediate medical attention is crucial to minimize brain damage and improve outcomes.