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Rivaroxaban for Atrial Fibrillation (NEW-AF Trial)
NEW-AF Trial Summary
This trial compares the safety and financial benefits of two different drugs to prevent blood clots in people with a heart condition.
- Atrial Fibrillation
- Bleeding
- Stroke
NEW-AF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowNEW-AF Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 3 trial • 179 Patients • NCT02164578NEW-AF Trial Design
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Who is running the clinical trial?
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- You are taking medication to prevent blood clots after surgery that cannot be stopped when another blood thinning medication is started.Your kidneys are not working well (GFR < 30 ml/min), you have abnormal blood clotting (baseline INR > 1.7), you have a blockage in your digestive system that makes it hard to take oral medication, or you have known problems with your body's ability to clot blood.You have a type of irregular heart rhythm called paroxysmal atrial fibrillation before heart surgery.You have experienced bleeding after a surgery before starting the study drug.You currently need to take medication to prevent blood clots, like for a previous blood clot or heart valve issue.You have a moderate to severe narrowing of your mitral valve that hasn't been fixed with surgery.You are already allergic to the medications used in the study.You have had heart surgeries like bypass grafting, valve repairs, or non-mechanical valve replacements.You have had a stroke within the past month before surgery or after surgery but before starting the study medication.
- Group 1: Warfarin
- Group 2: Rivaroxaban
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- 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.
- 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
How many individuals have volunteered to participate in this research project?
"That is correct, the online information shows that the trial is currently looking for volunteers. The 300 participants will be recruited from a single site, and the trial was originally posted on April 30th, 2019 with the most recent update being on August 31st, 2021."
Did the FDA sign off on Rivaroxaban?
"There is some evidence for rivaroxaban's efficacy and several rounds of data backing its safety, so it was given a score of 3."
Are there other studies that have looked at Rivaroxaban's effects?
"Presently, there are 76 independent clinical trials being conducted for Rivaroxaban. 30 of those trials have advanced to Phase 3. The majority of research facilities are based in Montreal, Quebec; however, there are 1065 total locations running Rivaroxaban trials."
Are patients still being actively recruited for this trial?
"That is correct, the information on clinicaltrials.gov currently indicates that this study is looking for participants. This study was originally posted on April 30th, 2019 and was last updated on August 31st, 2021. The study is searching for 300 patients from 1 location."
For what purpose is Rivaroxaban most often prescribed?
"Rivaroxaban is most commonly used to treat patients that have had a cerebrovascular accident. That being said, it can also be used as a preventative measure for people with atrial fibrillation or those that have had a myocardial infarction."
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