Ongoing Clinical Trials for Embolic Stroke
Currently, there are 2 clinical trials investigating new approaches to prevent embolic stroke in patients with specific risk factors. These studies are examining different medications that may help reduce inflammation and prevent blood clots in people who have experienced stroke or mini-stroke, or who have undergone treatment for irregular heart rhythms.
Clinical trial locations
- Belgium
- Germany
- Ireland
Study on Colchicine for Reducing Inflammation in Patients with Stroke or TIA and Atherosclerosis
This trial is investigating whether colchicine, a medication with anti-inflammatory properties, can help reduce inflammation in people who have experienced a stroke or transient ischemic attack (TIA, also called a “mini-stroke”). The study focuses on patients who also have atherosclerosis, which is a buildup of fatty deposits in the arteries.
Who can participate: The trial is looking for adults between 18 and 90 years old who have had a previous ischemic stroke or TIA and are living independently at home. Participants must be medically stable, have good kidney function (eGFR greater than 50 ml/min), and show signs of inflammation in their blood (hsCRP level of 2 mg/L or higher). Additionally, participants must have evidence of atherosclerosis, either in the arteries near the stroke area or a history of ischemic heart disease or peripheral arterial disease.
Who cannot participate: The study excludes pregnant or breastfeeding women, people with severe kidney or liver problems, those with a known allergy to colchicine, individuals who have had recent infections or surgery, and those currently taking certain medications that might interfere with the study drug. People with a history of certain cancers, uncontrolled high blood pressure, alcohol or drug abuse, unstable heart conditions, or those unable to follow study procedures are also excluded.
Study focus: The main goal is to determine whether taking colchicine once daily for 30 days can lower blood markers of inflammation, such as hsCRP and IL-6. These markers indicate inflammation levels in the body, and reducing them might lower the risk of having another stroke or heart-related problems. Researchers will take blood samples before and after treatment to measure changes in these markers.
Investigational drug: The study uses Colchicine Tiofarma 500 microgram tablets taken orally once a day for 30 days. Colchicine works by interfering with the activity of inflammatory cells in the body, potentially reducing the risk of further vascular events.
Study on Long-Term Anticoagulation with Rivaroxaban vs. Acetylsalicylic Acid for Patients at Risk of Stroke After Atrial Fibrillation Ablation
This trial is comparing two different approaches to preventing stroke in patients who have undergone catheter ablation for atrial fibrillation, a heart rhythm disorder that increases stroke risk. The study is testing whether long-term treatment with rivaroxaban (a blood thinner) is more effective than acetylsalicylic acid (aspirin) in preventing strokes and related events.
Who can participate: The trial is recruiting patients who are at least one year past a successful catheter ablation procedure for atrial fibrillation, with no signs of irregular heartbeats confirmed by heart monitoring tests. Participants must be over 18 years old and have a CHA2DS2-VASc risk score of 1 or more, which estimates stroke risk. They must also have non-valvular atrial fibrillation, meaning the irregular heart rhythm is not caused by valve problems.
Who cannot participate: The study excludes patients who have recently had a stroke or TIA, those with bleeding disorders, severe liver disease, or kidney disease requiring dialysis. Pregnant or breastfeeding women cannot participate, nor can people who are unable to follow study procedures or are participating in another clinical trial.
Study focus: The main objective is to determine whether continuing long-term treatment with rivaroxaban is better than using aspirin alone in preventing strokes and similar events in moderate-risk patients after successful catheter ablation. The study will last up to 36 months, during which participants will have regular check-ups and tests. Researchers will monitor the occurrence of strokes, bleeding events, changes in brain scans using MRI, and overall quality of life.
Investigational drugs: The study uses two medications: rivaroxaban (Xarelto 15 mg tablets) and acetylsalicylic acid (ASS-ratiopharm 100 mg tablets), both taken orally. Rivaroxaban is a type of anticoagulant that prevents blood clots by thinning the blood, while aspirin is an antiplatelet medication that stops platelets from clumping together. Some participants may receive a placebo, which looks like the real medication but contains no active ingredients.
Summary
These two clinical trials represent different approaches to preventing embolic stroke in specific patient populations. The Irish study focuses on using anti-inflammatory medication (colchicine) in patients with a history of stroke or TIA and atherosclerosis, while the study conducted in Belgium and Germany examines the best blood-thinning strategy for patients who have undergone treatment for atrial fibrillation.
Both trials aim to reduce the risk of recurrent strokes, but through different mechanisms. The colchicine study targets inflammation in blood vessels, while the anticoagulation study compares two different approaches to preventing blood clots. Patients interested in participating should discuss their eligibility with their healthcare provider, as each trial has specific requirements regarding medical history, current health status, and risk factors.
