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Study of Drug Combination with Amodiaquine and Potassium Canrenoate Plus Exenatide or Glibenclamide for 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 study is looking at Acute Ischemic Stroke, which is a condition where blood flow to part of the brain is suddenly blocked, causing brain cells to become damaged. The study will test different combinations of medications to see if they can help patients recover better. The medications being tested are amodiaquine, potassium canrenoate, exenatide, and glibenclamide. These medications will be compared to best medical therapy, which is the standard care that patients normally receive for this condition. The purpose of the study is to check the safety of these medication combinations, particularly looking at whether they increase the risk of bleeding in the brain, which is called hemorrhagic transformation.

Patients in the study will be divided into different groups. Some groups will receive combinations of the study medications along with their standard care, while another group will receive only standard care. The medications will be given in different forms, including injections under the skin, injections into a vein, and liquids taken by mouth. Treatment will start within 36 hours after stroke symptoms begin and will continue for a certain period. During the study, patients will have regular check-ups and tests to see how they are doing.

The study will use brain imaging tests like CT scans and MRI to look at the brain and check for any bleeding or changes in the damaged area. Doctors will also measure how well patients can perform daily activities and check their stroke symptoms using special scoring systems. Blood tests will be done to measure medication levels and other substances in the blood. The study will also check for side effects, including whether patients develop depression, and will monitor overall safety throughout the treatment period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Treatment initiation
Treatment will begin within a maximum of 36 hours from the time symptoms started.
The type of treatment received will be determined by random assignment. This means it will be decided by chance, similar to flipping a coin.
Treatment options include either a combination of medications (amodiaquine, potassium canrenoate, and either exenatide or glibenclamide) or standard medical care alone.
Step 2
Medication administration
If assigned to receive the investigational combination treatment, the following medications may be administered:
Exenatide will be given as an injection under the skin at a concentration of 3.5 micrograms per milliliter.
Potassium canrenoate may be given as an injection into a vein at a concentration of 5 milligrams per milliliter, or as an oral liquid at a dose of 25 milligrams per 5 milliliters.
Amodiaquine may be given as an injection into a vein at a concentration of 2 milligrams per milliliter.
Amodiaquine combined with glibenclamide may be given as an oral liquid at a dose of 10 milligrams of amodiaquine and 0.1 milligrams of glibenclamide per 5 milliliters.
The specific medications, doses, frequency, and duration will be determined by the treatment plan assigned.
Step 3
Brain imaging on day 5
On day 5 after treatment begins, a brain scan will be performed.
This scan may be a CT scan (a type of X-ray that creates detailed images) or an MRI scan (a scan that uses magnets and radio waves to create images).
The scan will check for any bleeding in the brain and measure the size of the area affected by the stroke.
Step 4
Ongoing monitoring and rehabilitation
Throughout the study period, standard physical, occupational, and speech therapies will be provided as needed based on difficulties caused by the stroke.
Blood samples will be collected at scheduled times to measure medication levels and other markers in the blood.
Regular assessments will be performed to evaluate neurological function and disability level.
Depression screening will be conducted using a questionnaire. A score above 10 on this assessment indicates possible depression.
Any side effects or health changes will be monitored and recorded.
Step 5
Brain imaging on day 90
On day 90 (approximately 3 months) after treatment begins, another brain scan will be performed.
This MRI scan will measure changes in the affected brain area and blood vessel status compared to the earlier scan.
The scan will help determine how the brain has responded to treatment over time.
Step 6
Final assessments
At the end of the study period, final evaluations will be completed.
These will include assessments of disability level, neurological function, and overall recovery.
Laboratory tests will be reviewed to identify any abnormal results that may be clinically significant.
Mental health status will be assessed to determine if depression has developed during the study.

Who can join the trial?

14 criteria

You must be between 18 and 80 years old at the time you sign the consent form.
You must either have no history of depression (a condition causing persistent feelings of sadness and loss of interest), or if you have been treated for depression, you must have been taking the same antidepressant medications (medicines used to treat depression) for at least 8 weeks before joining the study.
You must have no known history of dementia (a condition that affects memory and thinking abilities).
You or your caregiver or legal representative must sign a consent form agreeing to follow all study requirements and rules.
You are expected to receive standard physical therapy (exercises to improve movement), occupational therapy (activities to help with daily tasks), and speech therapy (treatment to help with speaking and swallowing) as needed after your stroke.
You or your caregivers must understand the study procedures and be willing to follow them throughout the entire study.
You must have a confirmed diagnosis of acute ischemic stroke (a sudden blockage of blood flow to the brain), diagnosed using a CT scan (a type of imaging test).
Your stroke must be located in the supratentorial area (the upper part of the brain) and must be nonlacunar (not a small, deep stroke), with a size larger than 15 millimeters in one direction as shown on the CT scan.
Your NIHSS score (a scale that measures stroke severity, with higher numbers indicating more severe strokes) at screening must be between 5 and 20 points.
Treatment must begin within 36 hours from when your stroke symptoms first started.
Before your stroke, you must have been able to perform daily activities independently without needing nursing care, based on information from you or your caregivers.
You must not be eligible for thrombolysis with tPA (a treatment using a clot-dissolving medication).
You must not be eligible for thrombectomy (a procedure to physically remove a blood clot).
If you have diabetes (a condition affecting blood sugar levels), you must have been taking the same diabetes medications for at least 8 weeks before joining the study.

Who cannot join the trial?

4 criteria

The source data does not contain specific exclusion criteria for this clinical trial
This study is about acute ischemic stroke, which means a sudden blockage of blood flow to the brain
The trial compares an investigational treatment with best medical therapy, which means the standard care currently used by doctors
The study focuses on safety regarding hemorrhagic transformation, which means bleeding that can occur in the brain after a stroke

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Verified sites

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University General Hospital Attikon
Athens, Greece
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University General Hospital Of Alexandroupoli
Alexandroupoli, Greece

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Investigated drugs

Amodiaquine
is a medication that is being tested in combination with other treatments in this stroke study. It will be given together with potassium canrenoate and either exenatide or glibenclamide to see if this combination can help patients who have had an acute ischemic stroke.
Potassium Canrenoate
is a medication that is being tested in combination with other treatments in this stroke study. It will be given together with amodiaquine and either exenatide or glibenclamide to see if this combination can help patients who have had an acute ischemic stroke.
Exenatide
is a medication that is being tested in combination with amodiaquine and potassium canrenoate in this stroke study. Some patients will receive this medication as part of their treatment combination to see if it can help patients who have had an acute ischemic stroke.
Glibenclamide
is a medication that is being tested in combination with amodiaquine and potassium canrenoate in this stroke study. Some patients will receive this medication as part of their treatment combination to see if it can help patients who have had an acute ischemic stroke.

What is already known about the treatment

Amodiaquine
Amodiaquine is an antimalarial medication that is typically taken by mouth in tablet form and is being studied in combination with other drugs for the treatment of acute ischemic stroke. Originally developed and approved for treating malaria, researchers are now investigating whether it can help protect brain cells after a stroke by reducing inflammation and preventing cell death at the molecular level. The drug works by interfering with certain chemical processes in cells that can cause damage during a stroke, and it belongs to a class of medications called antimalarials, though in this trial it is being tested for a completely different use in stroke patients.
Potassium Canrenoate
Potassium canrenoate is a medication given by injection into a vein that acts as a diuretic, meaning it helps the body remove excess fluid, and is being tested in combination with other drugs for treating acute ischemic stroke. This drug is already used in medical practice for conditions involving fluid retention, but researchers are exploring whether it can also protect the brain after a stroke by blocking certain hormones that may worsen brain swelling and damage. At the molecular level, it works by blocking receptors for a hormone called aldosterone, which can contribute to inflammation and tissue injury, and it belongs to a class of drugs known as potassium-sparing diuretics or aldosterone antagonists.
Exenatide
Exenatide is a medication that is injected under the skin and is currently approved for treating type 2 diabetes, but is being studied as a potential treatment for acute ischemic stroke. The drug works by mimicking a natural hormone in the body that helps regulate blood sugar levels, and researchers believe it may also protect brain cells from damage after a stroke by reducing inflammation and promoting cell survival at the molecular level. It belongs to a class of medications called GLP-1 receptor agonists, which activate specific receptors on cells to trigger protective effects, and in this trial it is being tested to see if it can improve outcomes for stroke patients beyond its usual diabetes treatment role.
Glibenclamide
Glibenclamide is a medication taken by mouth in tablet form that is currently approved for treating type 2 diabetes by helping to lower blood sugar levels, but is being investigated as a treatment for acute ischemic stroke. The drug works by closing certain channels in cell membranes that can open during a stroke and cause dangerous swelling in the brain, potentially preventing serious complications like brain herniation. At the molecular level, it blocks sulfonylurea receptors and associated potassium channels, and it belongs to a class of medications called sulfonylureas, though in stroke treatment it is being used for its ability to reduce brain swelling rather than its blood sugar-lowering effects.

Investigated diseases

Acute Ischemic Stroke – A condition that occurs when blood flow to a part of the brain is suddenly blocked, usually by a blood clot in an artery. When brain cells are deprived of oxygen and nutrients carried by blood, they begin to die within minutes. This leads to the loss of functions controlled by the affected area of the brain, such as movement, speech, or memory. Symptoms typically appear suddenly and may include weakness or numbness on one side of the body, difficulty speaking or understanding speech, vision problems, dizziness, or loss of balance. The severity of the stroke depends on which part of the brain is affected and how much brain tissue is damaged. Without restored blood flow, the affected brain tissue continues to deteriorate, potentially causing permanent disability.