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Abelacimab vs. Rivaroxaban for Atrial Fibrillation (AZALEA-TIMI 71 Trial)
AZALEA-TIMI 71 Trial Summary
This trial is looking at whether a new drug, abelacimab, is better than the current standard of care, rivaroxaban, at reducing bleeding in patients with a heart condition called atrial fibrillation.
AZALEA-TIMI 71 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAZALEA-TIMI 71 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.AZALEA-TIMI 71 Trial Design
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Who is running the clinical trial?
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- I am 55 years old or older.I am on blood thinners for reasons other than atrial fibrillation.I have a tumor in my heart's left chamber or a blood clot in my heart.You have a certain score on a risk assessment tool for stroke called CHA2DS2-VASc.I have not had a brain or eye bleed in the last 3 months.My kidney function, measured by creatinine clearance, is 50 ml/min or less.I have a history of irregular heartbeats and will be on blood thinners indefinitely.I will be taking aspirin or P2Y12 inhibitors throughout the trial.My kidney function, measured by creatinine clearance, is 50 ml/min or less.I will be taking aspirin or P2Y12 inhibitors throughout the trial.I have an active infection in my heart's inner lining.I have had surgery to close or remove the left atrial appendage of my heart.I have a narrow mitral valve in my heart.I am not allergic to rivaroxaban or similar medications.I am 55 years old or older.I have a history of AF or atrial flutter and will be on blood thinners indefinitely.
- Group 1: Abelacimab (MAA868)
- Group 2: Rivaroxaban
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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 indications usually warrant the administration of Abelacimab?
"Abelacimab is an efficacious remedy for venous thromboembolism, chronic coronary artery disease, and deep vein thrombosis."
How many locations in the US are hosting this research initiative?
"Currently, seven clinical sites are running this trial, located in Saint Augustine, Falls Church and Odessa as well as a few other cities. To reduce travel burden for participants, it is ideal to choose the closest site available."
How many participants are enrolled in this medical trial?
"At this point in time, the trial is no longer recruiting. It was first published on February 2nd 2021 and last updated May 16th 2022. If you are seeking alternate opportunities for study participation, 1466 stroke-related studies and 60 Abelacimab trials are currently enrolling patients."
How risky is Abelacimab for people under treatment?
"Our evaluation at Power assigned Abelacimab a score of 2, as Phase 2 trials have exhibited promising safety results but not efficacy."
Is there still an opportunity for individuals to partake in this research?
"At this moment in time, no further participants are being sought for this trial. Initially posted on February 2nd 2021 and last updated May 16th 2022, it is now closed to new enrolment. However if you're looking for studies related to stroke there are 1466 trials actively recruiting patients, as well as 60 other clinical trials which involve Abelacimab that have open opportunities for volunteers."
Is this research initiative unprecedented in its conception?
"Abelacimab has been subject to scientific inquiry for the past six years, beginning with a 2180-patient study by Bayer Healthcare Pharmaceuticals/Schering Pharma in 2015. Subsequently approved for Phase 3 clinical trials, there are currently 60 active studies of Abelacimab spread across 352 cities and 37 nations."
Has there been any other research done on Abelacimab outside of this current investigation?
"Abelacimab was initially tested in 2015 at Montreal Heart Institute. Since then, 221 trials have been finalized and 60 are currently being conducted, mostly based in Saint Augustine, Florida."
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