This clinical trial is focused on studying the prevention of ischemic stroke in individuals who have recently experienced an acute non-cardioembolic ischemic stroke or a high-risk transient ischemic attack (TIA), which is often referred to as a mini-stroke. The study is testing a medication called asundexian, also known by its code name BAY 2433334. This medication is being compared to a placebo to see if it can better prevent strokes when used alongside standard antiplatelet therapy, which is a treatment that helps prevent blood clots.
The purpose of the study is to evaluate the effectiveness and safety of asundexian in reducing the risk of ischemic strokes. Participants in the study will be randomly assigned to receive either asundexian or a placebo. The study will monitor the time it takes for participants to experience another ischemic stroke or any major bleeding events, which are significant bleeding episodes that can occur in the body. The trial will also look at other outcomes, such as the occurrence of any type of stroke, heart-related events, and overall survival rates.
Throughout the study, participants will take the medication orally in the form of a film-coated tablet. The trial is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, ensuring unbiased results. The study aims to provide valuable information on whether asundexian can offer better protection against strokes compared to current treatments.
1joining the study
Upon joining the study, participants are required to meet certain criteria, including being 18 years or older and having experienced an acute non-cardioembolic stroke or a high-risk transient ischemic attack (TIA).
2randomization
Participants are randomly assigned to receive either the study medication, asundexian, or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives the actual medication.
3medication administration
The study medication, asundexian, is administered orally in the form of a film-coated tablet. The dosage and frequency are determined by the study protocol and are taken alongside standard antiplatelet therapy.
4monitoring and follow-up
Participants are monitored for the occurrence of ischemic strokes and any major bleeding events as defined by the International Society on Thrombosis and Hemostasis (ISTH).
Regular follow-up visits are scheduled to assess the participant’s health and any side effects from the medication.
5study duration
The study is expected to continue until October 10, 2025. Participants will remain in the study for the duration, unless they choose to withdraw or are advised to do so for health reasons.
Who Can Join the Study?
Participants must be 18 years of age or older.
Must have experienced an acute non-cardioembolic stroke or a high-risk transient ischemic attack (TIA). A non-cardioembolic stroke is a type of stroke not caused by a heart problem. A transient ischemic attack (TIA) is often called a “mini-stroke” and is a temporary period of symptoms similar to those of a stroke.
Must have systemic or cerebrovascular atherosclerosis or an acute non-lacunar infarct. Atherosclerosis is a condition where the blood vessels become narrowed or blocked due to a buildup of fats, cholesterol, and other substances. An acute non-lacunar infarct is a type of stroke that affects larger areas of the brain.
Who Cannot Join the Study?
Patients who have had a type of stroke called a cardioembolic stroke. This is a stroke caused by a blood clot that comes from the heart.
Patients who have a high risk of bleeding. This means they might bleed more easily than usual.
Patients who are currently taking certain medications that affect blood clotting, other than the ones allowed in the study.
Patients with severe liver disease. The liver is an organ that helps with digestion and cleaning the blood.
Patients with severe kidney disease. The kidneys are organs that help filter waste from the blood.
Patients who have had a recent major surgery. Surgery is an operation done by doctors to fix or remove something inside the body.
Patients who have a condition called uncontrolled high blood pressure. This means their blood pressure is too high and not being managed well with treatment.
Patients who are pregnant or breastfeeding. This means women who are expecting a baby or feeding a baby with breast milk.
Patients who have a history of allergic reactions to similar medications. An allergic reaction is when the body reacts badly to something, like a rash or trouble breathing.
Patients who are participating in another clinical trial. This means they are already part of a different study testing another treatment.
Asundexian is an oral medication being studied for its ability to prevent ischemic strokes. It works by inhibiting a specific factor in the blood clotting process, which may help reduce the risk of stroke in patients who have recently experienced a non-cardioembolic ischemic stroke or a high-risk transient ischemic attack (TIA). The trial aims to determine if asundexian is more effective than standard treatment in preventing further strokes.
Ischemic Stroke – An ischemic stroke occurs when a blood clot blocks or narrows an artery leading to the brain, causing a reduction in blood flow. This lack of blood flow results in brain cells being deprived of oxygen and nutrients, leading to their damage or death. Symptoms can include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, or difficulty seeing. The progression of an ischemic stroke can vary, with some individuals experiencing rapid onset of symptoms, while others may have a more gradual progression. Immediate medical attention is crucial to minimize brain damage. Recovery and progression depend on the stroke’s severity and the affected brain area.
Transient Ischemic Attack (TIA) – Often referred to as a mini-stroke, a transient ischemic attack occurs when there is a temporary reduction in blood flow to a part of the brain. This results in stroke-like symptoms that typically last for a few minutes to a few hours but do not cause permanent damage. Common symptoms include sudden weakness, numbness, or difficulty speaking. TIAs are often warning signs of a potential future stroke and indicate underlying issues with blood flow. The symptoms usually resolve quickly, but they should not be ignored. Prompt medical evaluation is essential to address risk factors and prevent a full-blown stroke.
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