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Study on Imatinib for Improving Recovery in Patients with Acute Ischemic Stroke

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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 the medication Imatinib in patients who have experienced an acute ischemic stroke. An acute ischemic stroke occurs when a blood clot blocks a blood vessel in the brain, leading to a sudden loss of blood flow and causing brain cells to die. The study aims to determine if taking Imatinib, at a dose of 800 milligrams per day, can improve recovery and functional outcomes for patients three months after the stroke. The treatment is started within eight hours of the stroke symptoms appearing and continues for six days.

Participants in the study will be randomly assigned to receive either the actual medication, Imatinib, or a placebo, which is a substance with no active drug. The study is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving the actual medication or the placebo, to ensure unbiased results. The medication is administered in two forms: as a film-coated tablet taken orally and as a solution for infusion given intravenously. The trial will monitor changes in the participants' ability to function independently and their overall neurological health at various points, including 24 hours, seven days, and three months after the stroke.

The primary goal is to see if there is a favorable change in the modified Rankin Scale (mRS) score, which measures the degree of disability or dependence in daily activities, in those treated with Imatinib compared to those who receive the placebo. Secondary outcomes include assessing the level of independence, the occurrence of any brain swelling or bleeding, and the rate of serious and non-serious side effects. The study will also track mortality rates at three months to gather comprehensive data on the safety and effectiveness of Imatinib in treating acute ischemic stroke.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization and initial treatment
Upon joining the study, randomization occurs as soon as possible but not later than 8 hours after the onset of symptoms. If the stroke occurred during sleep, randomization must happen within 6 hours of waking up.
If intravenous (IV) thrombolysis is performed, randomization and administration of the study drug should occur within one hour after the completion of the IV thrombolysis infusion.
If endovascular thrombectomy is performed, randomization should occur within two hours after the procedure, and the study drug should be administered as soon as possible after randomization.
Step 2
Medication administration
The study involves the administration of Imatinib at a dosage of 800 mg per day.
The medication is administered orally and should be initiated within 8 hours of symptom onset.
The treatment continues for a duration of 6 days.
Step 3
Monitoring and follow-up
The primary goal is to observe changes in the modified Rankin Scale (mRS) score at 3 months, aiming for a favorable shift in the scale for those receiving Imatinib compared to placebo.
Secondary observations include functional independence at 3 months, neurological outcomes at 24 hours, 7 days, or upon discharge, and at 3 months.
Monitoring includes the frequency and severity of any intracranial hemorrhage and cerebral edema on post-treatment imaging scans, especially in patients undergoing IV thrombolysis or endovascular thrombectomy.
The occurrence of serious and non-serious adverse events is recorded, along with mortality rates at 3 months.

Who can join the trial?

6 criteria

The patient must have a clinical diagnosis of acute ischemic stroke. This means a sudden problem with brain function due to a lack of blood flow, confirmed by a doctor.
The patient must be between the ages of 18 and 89 years old.
The patient should be included in the study as soon as possible, but no later than 8 hours after symptoms start. If the stroke happened during sleep, the patient should be included within 6 hours of waking up.
If the patient receives intravenous thrombolysis (a treatment to dissolve blood clots), it must be started within 4.5 hours of the stroke starting, following specific guidelines.
If the patient undergoes endovascular thrombectomy (a procedure to remove a blood clot from a blood vessel in the brain), it must be done according to specific guidelines and within 8 hours of symptoms starting, or within 6 hours if the stroke happened during sleep.
The patient must be able to make decisions and must agree to participate in the study, including allowing their data to be collected and stored.

Who cannot join the trial?

10 criteria

Patients who have had a **stroke** caused by bleeding in the brain, known as a **hemorrhagic stroke**.
Patients who have had a **major surgery** within the last 30 days.
Patients with a history of **severe heart problems**, such as a recent heart attack.
Patients who are currently taking certain medications that might interfere with the study drug.
Patients with **severe liver or kidney disease**.
Patients who are pregnant or breastfeeding.
Patients who have a known allergy to the study drug or similar medications.
Patients who have participated in another clinical trial within the last 30 days.
Patients with a history of **cancer** that is not in remission.
Patients with **uncontrolled high blood pressure**.

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Verified sites

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Danderyds Sjukhus AB
Verified
Danderyd, Sweden
Region Vaesterbotten
Responsive
Umea, Sweden
Soedersjukhuset AB
Responsive
Stockholm, Sweden

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Investigated drugs

Imatinib is a medication being tested in this clinical trial to see if it can help improve recovery after an acute ischemic stroke. The trial is studying whether starting treatment with Imatinib within 8 hours of stroke symptoms and continuing for 6 days can lead to better functional outcomes three months later.

What is already known about the treatment

Imatinib – Imatinib is administered orally in tablet form and is currently being studied in a phase 3 clinical trial for its potential use in treating acute ischemic stroke. This medication is well-documented in medical literature, primarily for its use in treating certain types of cancer, but its application in stroke treatment is still under investigation. The main therapeutic indication being explored is the improvement of functional outcomes following an acute ischemic stroke. At the molecular level, Imatinib works by inhibiting specific protein tyrosine kinases, which are involved in the signaling pathways that can lead to cell growth and division. It is classified pharmacologically as a tyrosine kinase inhibitor.

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, leading to potential loss of brain function. Symptoms can include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, vision problems, dizziness, and loss of balance. The progression of the disease can vary, with some individuals experiencing mild effects and others facing significant impairments. Immediate medical attention is crucial to minimize brain damage and improve outcomes. Recovery and the extent of regained function can differ widely among individuals.