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Study of ApTOLL for Treating Acute Ischemic Stroke in Patients Before Hospital Arrival

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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 treatment of 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 ApTOLL, which is a concentrate for injection or infusion. It is designed to be used as a neuroprotector, which means it aims to protect nerve cells from damage. The study will also use a placebo, which is a substance with no active medication, to compare the effects of ApTOLL.

The purpose of this study is to evaluate if administering ApTOLL intravenously, which means directly into a vein, is feasible, safe, and effective for patients with Acute Ischemic Stroke before they reach the hospital. This will be done using the RACE scale, a tool used by medical professionals to quickly assess the severity of a stroke. Participants will receive either ApTOLL or a placebo while they are still in the ambulance. The study will help guide future research on this treatment.

During the study, participants will be monitored for any serious side effects and their recovery will be assessed over a period of 90 days. This includes checking their neurological status, which refers to the health of their nervous system, and measuring the size of the stroke-affected area in the brain using MRI, a type of imaging that provides detailed pictures of the brain. The study aims to understand how well ApTOLL works in protecting the brain and improving outcomes for stroke patients.

The research process

The trial runs in 5 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, you will be randomly assigned to receive either the study medication ApTOLL or a placebo. This process is done to ensure that the study results are unbiased.
The study medication is administered through an intravenous (IV) line, which means it is given directly into your bloodstream.
Step 2
Medication administration
If you are assigned to receive ApTOLL, the dosage will be 0.2 mg per kilogram of your body weight. This will be administered at the pre-hospital level, such as in an ambulance.
The administration of the medication is intended to be completed within six hours from the onset of stroke symptoms.
Step 3
Monitoring and follow-up
After receiving the medication, your condition will be closely monitored. This includes regular assessments of your neurological status and overall health.
You will be evaluated using various scales, such as the National Institutes of Health Stroke Scale (NIHSS) and the modified Rankin Scale, to measure your recovery and any changes in your condition.
Step 4
Hospitalization and further assessments
During your hospital stay, additional tests such as MRI scans may be conducted to assess the extent of the stroke and your response to the treatment.
Your progress will be tracked for up to 90 days after the initial treatment to evaluate the long-term effects and any potential side effects.
Step 5
Final evaluation
At the end of the 90-day period, a final evaluation will be conducted to determine the overall outcome of the treatment.
This evaluation will include a review of any adverse events, changes in your condition, and your overall recovery.

Who can join the trial?

6 criteria

Patients must have a suspected acute LVO (Large Vessel Occlusion) stroke, which is a type of stroke caused by a blockage in a large blood vessel in the brain. This is identified by a RACE scale score greater than 4, which is a tool used by medical professionals to assess stroke severity.
Patients must be identified in non-stroke ready centers or primary health centers before being transferred to a Comprehensive Stroke Center (CSC).
The time from when symptoms start to when the patient is randomized for the trial must be less than 6 hours. For strokes that occur during sleep, the time is considered from when symptoms are first noticed.
Patients should have non-significant pre-stroke functional disability, meaning they should have a modified Rankin Scale score between 0 and 2. This scale measures the degree of disability or dependence in daily activities.
Patients must be between the ages of 18 and 90 years old.
If the patient is a woman of childbearing potential, she must confirm her menstrual period and have a negative pregnancy test. Additionally, she must use highly effective birth control methods for 7 days after receiving the study drug. Women are considered of childbearing potential if they are fertile, have started menstruating, and are not post-menopausal or permanently sterile.

Who cannot join the trial?

9 criteria

Patients who have had a **recent head injury** or **trauma**. This means any injury to the head or body that happened recently.
Patients with a **history of bleeding disorders**. These are conditions where the blood does not clot properly, leading to excessive bleeding.
Patients who are currently taking **blood thinners**. These are medications that prevent blood clots but can increase the risk of bleeding.
Patients with **severe liver or kidney disease**. These are serious conditions affecting the liver or kidneys, which are important organs for filtering and processing substances in the body.
Patients who have had a **major surgery** in the last 30 days. This refers to any significant surgical procedure that requires a long recovery time.
Patients with **uncontrolled high blood pressure**. This means blood pressure that is consistently too high and not managed by medication or lifestyle changes.
Patients who are **pregnant or breastfeeding**. This includes women who are expecting a baby or are currently nursing a child.
Patients with a **known allergy** to the study medication. This means having a history of allergic reactions to the drug being tested.
Patients who have participated in another **clinical trial** within the last 30 days. This refers to being part of another research study recently.

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Verified sites

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

Bellvitge University Hospital
Verified
L'hospitalet De Llobregat, Spain
Hospital Universitari De Girona Doctor Josep Trueta
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Girona, Spain
Hospital Universitario Hermanos Trias y Pujol. Institut Catalá d'Oncología (ICO)
Verified
Badalona, Spain

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Investigated drugs

ApTOLL is a medication being tested in this clinical trial for its potential to help treat acute ischemic stroke. This type of stroke happens when a blood clot blocks or narrows an artery leading to the brain, reducing blood flow and causing brain cells to die. The trial is exploring whether giving ApTOLL through an intravenous (i.v.) injection in an ambulance, before reaching the hospital, is safe and effective. The goal is to see if this early treatment can improve outcomes for stroke patients and help guide future research.

Aptamer-4Ft

What is already known about the treatment

ApTOLL – ApTOLL is administered intravenously, meaning it is given directly into a vein, and in this study, it is applied at the pre-hospital level, such as in an ambulance. Currently, ApTOLL is being investigated in clinical trials for its potential use in treating Acute Ischemic Stroke (AIS), a condition where blood flow to the brain is blocked. The main goal of using ApTOLL is to determine if it is safe and effective in this emergency setting. At the molecular level, ApTOLL works by targeting specific pathways that may help reduce inflammation and protect brain cells during a stroke. It is classified pharmacologically as a neuroprotective agent, which means it is intended to protect nerve cells from damage.

Investigated diseases

Acute Ischemic Stroke (AIS) – Acute 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. The progression of AIS can lead to sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, or difficulty understanding speech. As the condition progresses, it may also cause vision problems, dizziness, loss of balance, or severe headache. The severity and specific symptoms depend on the location and extent of the blockage in the brain. Immediate medical attention is crucial to minimize brain damage and potential complications.