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Rivaroxaban for Atrial Fibrillation and Stroke Prevention (BRAIN-AF Trial)
BRAIN-AF Trial Summary
This trial is testing whether rivaroxaban is better than standard care at reducing stroke, TIA, and neurocognitive decline in people with non-valvular AF and low risk of stroke.
- Atrial Fibrillation
BRAIN-AF Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.BRAIN-AF Trial Design
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Who is running the clinical trial?
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- You have had an allergic reaction to acetylsalicylic acid (aspirin) in the past and you have vascular disease.You have low red blood cell count or low platelet count.You have been diagnosed with dementia.Your memory and thinking test score is less than 25.You have serious kidney problems.You have a certain type of irregular heart rhythm called valvular atrial fibrillation.You are taking other medications that prevent blood clotting.You have had bleeding in your stomach or intestines before.You have a medical condition that makes you more likely to bleed.You have a current, active infection in your heart.You currently have a liver disease that is not under control.You have had an allergic reaction to rivaroxaban in the past.You have had atrial fibrillation in the past 2 years shown on a heart tracing or device.You have a low chance of having a stroke based on certain conditions.
- Group 1: standard of care
- Group 2: Rivaroxaban
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the precedent for this clinical trial?
"Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma first sponsored a clinical trial for Rivaroxaban in 2015. This was the first of 61 ongoing trials as of today. These trials are located across 45 countries and 402 cities."
What is Rivaroxaban's main therapeutic purpose?
"Rivaroxaban is most often used to treat venous thromboembolism, but it is also an effective medication for deep vein thrombosis, cerebrovascular accident, and chronic coronary artery disease."
Can people with the condition being studied still enroll in the trial at this time?
"Indeed, the trial is still open for recruitment according to the information displayed on clinicaltrials.gov. This particular study was first posted on March 1st, 2015 and was most recently edited on October 14th, 2022. At the moment, 1 site is looking for 2180 participants."
Could you please delineate the risks associated with Rivaroxaban?
"Rivaroxaban received a safety score of 3 because there is Phase 3 trial data supporting its efficacy as well as multiple rounds of data backing up its safety."
Does this research involve patients that are octogenarians or younger?
"This specific study is only looking for participants between the ages of 30 and 62. In contrast, there are 19 trials targeting people under 18 and 872 trials targeting people over the age of 65."
To be eligible for this research, what are the requirements?
"This trial is seeking 2180 individuals that recently experienced a wake-up stroke. The patients must be aged between 30 and 62 years old. To meet the eligibility requirements, patients must also have non-valvular atrial fibrillation that has been documented in the last two years. Furthermore, the patients cannot have any of the following conditions: prior stroke or transient ischemic attack, hypertension, diabetes mellitus, or congestive heart failure."
How many study participants are using this medication?
"Yes, as the clinicaltrials.gov website shows, this study is looking for patients right now. The listing was first posted on March 1st, 2015, and updated on October 14th, 2020. They need 2180 people total, at just 1 location."
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