Ongoing Clinical Trials for Transient Ischaemic Attack
There are currently 3 ongoing clinical trials investigating different approaches to managing and preventing complications in patients with transient ischaemic attack. These trials are being conducted across multiple countries in Europe, testing medications that may help reduce the risk of future strokes and improve understanding of brain metabolism in patients who have experienced a TIA. (Also known as: TIA, mini-stroke)
Clinical trial locations
- Austria
- Belgium
- Bulgaria
- Czechia
- Denmark
- Finland
- France
- Germany
- Greece
- Hungary
- Italy
- Latvia
- Lithuania
- Netherlands
- Norway
- Poland
- Portugal
- Slovakia
- Spain
- Sweden
Study of Allopurinol to Reduce Cardiovascular Events in High-Risk Patients with Heart Disease and Long-COVID Syndrome
This trial is investigating whether allopurinol, a medication commonly used to lower uric acid levels in the blood, can help reduce the risk of serious cardiovascular events in patients at high risk of heart and blood vessel problems. The study includes patients who have experienced various cardiovascular conditions, including transient ischaemic attack.
Main inclusion criteria: Participants must be between 40 and 70 years old and have elevated blood uric acid levels above 5mg/dl. They must also meet at least one high cardiovascular risk condition, such as having a history of stroke or mini-stroke, heart failure, poor blood flow to legs, irregular heartbeat, or diabetes with signs of organ damage. The calculated 10-year risk of death from heart disease must be more than 2.5% for those under 50 years old, or 5% or higher for those 50 years or older.
Main exclusion criteria: Patients cannot participate if they are currently taking allopurinol or other uric acid-lowering medications, have a known allergy to allopurinol, or have severe kidney or liver disease. The study also excludes people with active cancer, pregnant or breastfeeding women, those with severe mental illness, alcohol or drug dependency, or those who have had recent major surgery within the last 3 months.
Study focus: The main goal is to determine whether allopurinol can prevent serious cardiovascular events such as heart problems, strokes, or the need for heart-related procedures. Participants will receive either allopurinol tablets or a placebo for approximately 5 years, with regular check-ups that include heart examinations, blood vessel ultrasounds, blood tests, blood pressure measurements, and heart rhythm checks. The study will also monitor kidney and liver function, as well as any long-COVID symptoms that may occur.
Investigational drug: Allopurinol works by blocking an enzyme that produces uric acid in the body. Researchers believe it may help protect the heart and blood vessels beyond its traditional use in managing high uric acid levels.
Study on Metabolic Impairment in ALS and TIA Patients Using Hyperpolarized Pyruvate MRI
This clinical trial uses a new imaging technique to study brain metabolism in patients with transient ischaemic attack. The study aims to provide a clearer understanding of how these events affect brain function at a metabolic level.
Main inclusion criteria: Participants must be between 18 and 85 years old. For the TIA group specifically, patients must have experienced a transient ischaemic attack within the last 10 days, with symptoms including weakness on one side of the body (either in a limb or the face) that lasted at least 10 minutes. Pre-menopausal women must have a negative pregnancy test.
Main exclusion criteria: Patients who do not have a diagnosis of TIA cannot participate. Additionally, vulnerable populations who are unable to give informed consent are excluded from the study.
Study focus: The primary focus is on assessing how the brain’s metabolism is affected by TIA. Participants will receive an injection of Hyperpolarized [1-13C]pyruvate and then undergo a special type of MRI scan. This technique helps doctors see how the brain processes energy by measuring the exchange of a specific marker from the injected substance to other metabolic products like bicarbonate, lactate, and alanine. The study combines these imaging results with clinical examinations and patient interviews to better understand the impact on brain health.
Investigational drug: Hyperpolarized [1-13C]pyruvate is a special form of a naturally occurring substance in the body. When injected and used during an MRI scan, it enhances the signals that show metabolic activity in the brain, allowing doctors to see changes in how the brain produces and uses energy.
Study on Asundexian for Preventing Ischemic Stroke in Adults After a Stroke or High-Risk Mini-Stroke
This large international trial is testing whether asundexian can better prevent future strokes when used alongside standard treatment in patients who have recently experienced an ischemic stroke or high-risk transient ischaemic attack.
Main inclusion criteria: Participants must be 18 years of age or older and have recently experienced an acute non-cardioembolic stroke (a stroke not caused by a heart problem) or a high-risk transient ischaemic attack. They must also have evidence of systemic or cerebrovascular atherosclerosis (narrowing of blood vessels due to buildup of fats and cholesterol) or an acute non-lacunar infarct (a type of stroke affecting larger areas of the brain).
Main exclusion criteria: Patients cannot participate if they have had a cardioembolic stroke (caused by a blood clot from the heart), have a high risk of bleeding, are taking certain blood-thinning medications not allowed in the study, or have severe liver or kidney disease. The study also excludes patients with uncontrolled high blood pressure, those who have had recent major surgery, pregnant or breastfeeding women, and people with a history of allergic reactions to similar medications.
Study focus: The trial evaluates whether asundexian is more effective than placebo in preventing future ischemic strokes when added to standard antiplatelet therapy (treatment that helps prevent blood clots). The study monitors the time it takes for participants to experience another ischemic stroke or major bleeding events. It also tracks other outcomes such as any type of stroke, heart-related events, and overall survival rates. The study is designed as a double-blind trial, meaning neither participants nor researchers know who receives the actual medication or placebo, ensuring unbiased results.
Investigational drug: Asundexian is an oral medication that works by blocking a specific protein involved in blood clot formation. It is taken as a film-coated tablet and aims to reduce the risk of stroke by preventing the formation of blood clots that can block blood flow to the brain.
Summary
The three ongoing clinical trials for transient ischaemic attack reflect different approaches to managing and understanding this condition. The asundexian trial represents the largest effort, being conducted across 20 European countries, and focuses specifically on stroke prevention in patients who have recently experienced a TIA or ischemic stroke. This wide geographical distribution may help gather diverse patient data and ensure broad applicability of results.
The studies test three distinct types of interventions: a novel anticoagulant (asundexian), a diagnostic imaging agent (hyperpolarized pyruvate), and a repurposed medication traditionally used for gout (allopurinol). This variety demonstrates the multiple angles from which researchers are approaching TIA management – from prevention of future events to understanding underlying metabolic changes to addressing cardiovascular risk factors.
Notably, two of the three trials focus on prevention of future cardiovascular events, highlighting the importance of secondary prevention in patients who have experienced a TIA. The inclusion of the metabolic imaging study in Denmark suggests growing interest in understanding the biological mechanisms underlying TIA at a cellular level, which may lead to new therapeutic targets in the future.
