Ongoing Clinical Trials for Cerebrovascular Accident
This article provides detailed information about 6 ongoing clinical trials investigating treatments for cerebrovascular accident (also known as stroke). These studies are exploring various approaches including medication therapy, brain imaging techniques, and prevention of complications following stroke. Trials are being conducted across multiple European countries including France, Netherlands, Denmark, Spain, Italy, Ireland, Norway, Sweden, Finland, Greece, Germany, and Belgium.
Clinical trial locations
- Belgium
- Denmark
- Finland
- France
- Study on Apathy in Stroke Patients Using Fluoroethoxybenzovesamicol F-18 and Fluorodopa (18F)
- Study on Deferiprone for Preventing Secondary Degeneration in Stroke Patients
- Study on the Effects of Botulinum Toxin A for Improving Arm Function in Patients with Chronic Stroke
- Study on Tranexamic Acid and Sodium Chloride for Patients with Stroke-Related Brain Bleeding
- Germany
- Greece
- Ireland
- Italy
- Netherlands
- Norway
- Spain
- Sweden
Study on Apathy in Stroke Patients Using Fluoroethoxybenzovesamicol F-18 and Fluorodopa (18F)
This study is investigating apathy, a condition characterized by lack of interest or motivation, which can occur following a stroke. The trial focuses on understanding how two important brain systems contribute to this condition.
Inclusion criteria: Patients must be between 18 and 75 years old with a Rankin score of 2 or less. The Rankin score measures how much help someone needs after a stroke, ranging from 0 (no symptoms) to 6 (death). Participants must be 3 to 7 months post-stroke, with or without apathy. Apathy is measured using the AI scale, where a score greater than 2 indicates its presence. All participants must be affiliated with a social security scheme and provide written informed consent. Women of childbearing age and female partners of male participants must use effective birth control methods.
Exclusion criteria: The study excludes patients who have not had a stroke in the last 3 to 7 months, those outside the specified age range, and individuals who do not meet the sex criteria or vulnerable population requirements for the study.
Study focus: The trial uses two specialized imaging substances, Fluoroethoxybenzovesamicol F-18 and Fluorodopa (18F), administered as injections. These substances help visualize the cholinergic system (involved in memory and learning) and the dopaminergic system (involved in mood and motivation). The research compares brain activity related to these systems in people who experience apathy after stroke versus those who do not. Participants undergo MRI scans to measure brain activity, connectivity, and blood flow.
Investigational drugs: The study uses cholinergic tracers to study the cholinergic system and dopaminergic tracers to examine the dopaminergic system. These tracers help researchers measure the activity and integrity of these important brain pathways in patients who have experienced a stroke.
Study on Stopping or Continuing Clopidogrel, Carbasalate Calcium, and Dipyridamole for Young Patients After Stroke Without a Known Cause
This trial examines whether young patients who have had a stroke without a known cause can safely stop taking blood-thinning medications, also known as antiplatelet therapy, several years after their initial event.
Inclusion criteria: Participants must have experienced their first ischemic stroke or transient ischemic attack (TIA) with evidence of reduced blood flow on imaging, occurring 3 to 10 years before joining the study. They must have been between 18 and 49 years old at the time of the event. The cause of the stroke must be cryptogenic, meaning no specific cause was identified after standard medical evaluation including brain and neck artery imaging, blood tests, at least 24 hours of heart rhythm monitoring, and heart ultrasound tests. Both men and women can participate.
Exclusion criteria: The study excludes patients whose stroke had a known cause, those outside the age range of 18 to 65 years, vulnerable populations, individuals unable to follow study procedures, those with interfering medical conditions, participants in other trials, pregnant or breastfeeding women, those with severe allergic reactions to study medications, and patients requiring medications that cannot be stopped for the study.
Study focus: The research investigates whether stopping antiplatelet therapy is as safe and effective as continuing it in preventing major cardiovascular events such as another stroke or heart attack, assessed 3 to 10 years after the initial event. Participants are randomly assigned to either continue or stop their medication, with some potentially receiving a placebo. The study monitors major health events, bleeding risk, overall survival, cost-effectiveness, and quality of life.
Investigational drugs: The study examines platelet inhibitors including Plavix and Clopidogrel Viatris (both containing clopidogrel), acetylsalicylic acid (aspirin), and combinations of dipyridamole with acetylsalicylic acid. These medications help prevent blood clots by stopping platelets from clumping together.
Study on Tranexamic Acid and Sodium Chloride for Patients with Stroke-Related Brain Bleeding
This international trial investigates whether tranexamic acid can reduce early deaths in patients who have experienced intracerebral hemorrhage, a serious type of stroke involving bleeding inside the brain.
Inclusion criteria: Participants must be adults aged 18 years or older who arrive at the hospital within 4.5 hours of symptom onset. They must have acute spontaneous intracerebral hemorrhage confirmed by brain scan. If the time symptoms started is unknown, patients must be within 4.5 hours of when symptoms were first noticed. Those taking direct oral anticoagulants (blood clot prevention medications) can participate. Informed consent is required.
Exclusion criteria: The study excludes patients who have had bleeding-related strokes, those outside the age range of 18 to 65 years, individuals unable to provide consent, pregnant or breastfeeding women, those with known allergies to study medication, current participants in other trials, and patients with severe medical conditions that might interfere with the study.
Study focus: The research evaluates whether tranexamic acid can help reduce early death within the first seven days after the bleeding event and improve patients’ ability to live independently six months later. Participants receive either tranexamic acid or a placebo through injection or infusion directly into the bloodstream. The study aims to determine if tranexamic acid should be used in regular medical practice for treating this type of stroke.
Investigational drugs: Tranexamic acid is a medication that helps blood clot more effectively, potentially slowing down or stopping brain bleeding. It works by blocking the breakdown of blood clots, which helps stabilize existing clots and reduce further bleeding.
Study on Apixaban and Edoxaban for Preventing Stroke in Patients with Recent Perioperative Atrial Fibrillation After Noncardiac Surgery
This study examines whether non-vitamin K oral anticoagulants can prevent strokes and related complications in patients who develop irregular heart rhythms after surgery.
Inclusion criteria: Patients must have undergone noncardiac surgery within the past 35 days, either with overnight hospital stay or significant day surgery. They must have experienced at least one episode of clinically important perioperative atrial fibrillation and be in normal heart rhythm when joining the study. High-risk criteria vary by age: those 55-64 years must have existing heart or blood vessel disease, recent major vascular surgery, a CHA2DS2VASc score of 3 or higher, or elevated troponin levels after surgery; those 65-74 years need similar conditions but with a CHA2DS2VASc score of 2 or higher; those 75 years or older automatically qualify. Written consent is required.
Exclusion criteria: The study excludes patients with recent major bleeding, severe liver or kidney disease, those taking other blood-thinning medications, pregnant or breastfeeding women, individuals with known allergies to study medication, recent stroke, severe heart disease, and those unable to follow study procedures.
Study focus: The research compares non-vitamin K oral anticoagulants with no anticoagulation treatment to prevent non-hemorrhagic stroke, systemic embolism (blood clots traveling through the bloodstream), vascular mortality, heart attacks, and blood clots in veins. Participants are randomly assigned to receive either a NOAC or no treatment for up to 120 days.
Investigational drugs: The study tests several non-vitamin K oral anticoagulants including Apixaban, Edoxaban, Rivaroxaban, and Dabigatran. These medications prevent blood clots by making it harder for blood to form clots, taken orally in tablet or capsule form.
Study on the Effects of Botulinum Toxin A for Improving Arm Function in Patients with Chronic Stroke
This trial investigates whether botulinum toxin type A injections can improve arm function in individuals experiencing muscle stiffness and spasms following a stroke.
Inclusion criteria: For the patient group, participants must have experienced an ischemic or hemorrhagic stroke more than 6 months ago and be older than 18 years. They need a medical reason to receive botulinum toxin type A injection in the elbow flexor muscles, specifically being prescribed abobotulinumtoxinA (DYSPORT®). Patients must be able to actively extend their elbow by at least 20 degrees, but their movement should be limited by at least 15 degrees or performed at 50% reduced speed. Participants should be new to this treatment or have had their first injection more than 4 months ago. Social security affiliation and informed consent are required. A control group of healthy individuals older than 18 years is also included.
Exclusion criteria: The study excludes patients with recent strokes, those unable to understand or follow instructions, individuals with serious interfering health conditions, pregnant or breastfeeding women, participants in other trials, those with medication allergies, and individuals with drug, alcohol abuse, or mental health conditions affecting participation.
Study focus: The research evaluates how botulinum toxin type A injections can reduce unwanted muscle contractions in the arm, particularly during elbow extension. The study measures changes in muscle activity and movement ability over time, comparing results before and after treatment through various assessments of muscle function and movement.
Investigational drugs: Botulinum toxin type A (Dysport 500 U) is injected into the elbow flexor muscles to reduce muscle stiffness and spasms. It works by blocking the release of acetylcholine, a neurotransmitter responsible for muscle contraction, helping to improve movement in patients with chronic paralysis following stroke.
Study on Deferiprone for Preventing Secondary Degeneration in Stroke Patients
This study explores whether Deferiprone (Ferriprox) can prevent further brain damage after a stroke by reducing harmful iron accumulation in the brain.
Inclusion criteria: Patients must be older than 18 years with social insurance coverage. They must have experienced a stroke affecting the middle cerebral artery, including at least half of the striatum region, either through main artery blockage or partial restoration that still affects the striatum. Neutrophil count (a type of white blood cell) must be at least 1.5 x 109/L. Women of childbearing potential must have a negative pregnancy test and use effective birth control (pills, intra-uterine device, or bilateral salpingectomy) for 6 months after the last medication dose. Male participants must ensure their partners use effective birth control or agree to use condoms during the study and for 90 days afterward. Written informed consent is required; if patients cannot provide consent due to severe communication or understanding problems from the stroke, a trusted person can provide consent on their behalf.
Exclusion criteria: The study excludes patients with proximal occlusion of the sylvian artery (blockage in a major brain blood vessel), those unable to undergo MRI scans, individuals outside the specified age range, those unable to take deferiprone, and vulnerable populations.
Study focus: The research investigates whether taking Deferiprone daily for six months can help prevent further brain damage by reducing iron accumulation. Participants undergo MRI scans at the beginning and end of the six-month period to assess changes in brain iron levels. The study monitors physical and cognitive abilities as well as mood throughout the treatment period.
Investigational drugs: Ferriprox (deferiprone) 500 mg film-coated tablets are administered orally at a low dose of 30 mg per kilogram of body weight daily. This iron chelating agent works by binding to iron molecules, allowing them to be excreted from the body, thus reducing harmful iron accumulation that can occur after a stroke.
Summary
These six clinical trials represent diverse approaches to improving outcomes for patients who have experienced cerebrovascular accidents. The research spans several important areas including understanding post-stroke complications like apathy, optimizing long-term medication management, treating acute bleeding complications, preventing strokes in high-risk surgical patients, improving physical function during recovery, and preventing secondary brain damage.
Notable observations include a strong concentration of trials in France, which hosts three of the six studies. The Scandinavian countries and broader European collaboration are particularly evident in the tranexamic acid and anticoagulation studies, which involve multiple countries working together. The trials demonstrate a balanced approach between prevention and treatment, with some focusing on preventing additional strokes while others address recovery and rehabilitation after the initial event.
Several trials focus on specialized populations: young patients with cryptogenic stroke, surgical patients developing atrial fibrillation, and those experiencing specific complications like apathy or muscle spasticity. The investigational approaches range from established medications being tested in new contexts to imaging studies aimed at better understanding the underlying mechanisms of post-stroke conditions.
Patients interested in participating should consult with their healthcare providers to determine which trial, if any, might be appropriate for their specific situation. Each study has unique eligibility requirements and investigates different aspects of stroke prevention, treatment, or recovery.
