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Monoclonal Antibodies

Abelacimab vs. Rivaroxaban for Atrial Fibrillation (AZALEA-TIMI 71 Trial)

Phase 2
Waitlist Available
Research Sponsored by Anthos Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female patients ≥ 55 years old
Creatinine Clearance (CrCl) ≤50 ml/min by the Cockcroft-Gault equation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization through study completion, an average of 17 months
Awards & highlights

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.

Who is the study for?
This trial is for adults aged 55 or older with atrial fibrillation at moderate-to-high stroke risk, who need long-term blood thinners. They should have a CHA2DS2-VASc score of ≥4, or ≥3 with certain conditions and planned use of antiplatelet meds. People can't join if they're allergic to the study drugs, had recent serious bleeding, significant heart valve narrowing, mechanical heart valves, other anticoagulant needs like clots, or specific heart conditions.Check my eligibility
What is being tested?
The ANT-006 study compares Abelacimab (MAA868) to Rivaroxaban in patients with atrial fibrillation to see which causes less bleeding. Patients are randomly assigned to receive either Abelacimab or Rivaroxaban as their anticoagulation therapy.See study design
What are the potential side effects?
Potential side effects include bleeding risks associated with any blood thinner such as bruising easily and prolonged bleeding from cuts. Specific side effects related to each drug will be monitored but may not be fully known until the trial concludes.

AZALEA-TIMI 71 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 55 years old or older.
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My kidney function, measured by creatinine clearance, is 50 ml/min or less.
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I have a history of irregular heartbeats and will be on blood thinners indefinitely.
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I will be taking aspirin or P2Y12 inhibitors throughout the trial.
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My kidney function, measured by creatinine clearance, is 50 ml/min or less.
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I will be taking aspirin or P2Y12 inhibitors throughout the trial.
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I am 55 years old or older.
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I have a history of AF or atrial flutter and will be on blood thinners indefinitely.

AZALEA-TIMI 71 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization through study completion, an average of 17 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization through study completion, an average of 17 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate effect of abelacimab relative to rivaroxaban on the rate of major or clinically relevant non-major (CRNM) bleeding events
Secondary outcome measures
Evaluate effect of abelacimab relative to rivaroxaban on the rate of major bleeding events
Evaluate the effect of abelacimab relative to rivaroxaban on the rate of major or minor bleeding events

AZALEA-TIMI 71 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Abelacimab (MAA868)Experimental Treatment1 Intervention
Treatment group 1: Abelacimab middle dose subcutaneous (s.c.) monthly Treatment group 2: Abelacimab high dose subcutaneous (s.c.) monthly Extension Treatment Group: Abelacimab high dose subcutaneous (s.c.) monthly
Group II: RivaroxabanActive Control1 Intervention
Treatment group 3: Rivaroxaban 20 mg by mouth; orally (p.o.) once per day with the evening meal Patients with a Creatinine Clearance (CrCl) ≤50 ml/min by the Cockcroft-Gault equation will have a dose adaptation to rivaroxaban 15 mg p.o. daily.

Find a Location

Who is running the clinical trial?

Laboratory Corporation of AmericaIndustry Sponsor
27 Previous Clinical Trials
8,685 Total Patients Enrolled
Anthos Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
14,603 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
11,928 Patients Enrolled for Atrial Fibrillation
The TIMI Study GroupOTHER
12 Previous Clinical Trials
82,235 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
21,105 Patients Enrolled for Atrial Fibrillation

Media Library

Abelacimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04755283 — Phase 2
Atrial Fibrillation Research Study Groups: Abelacimab (MAA868), Rivaroxaban
Atrial Fibrillation Clinical Trial 2023: Abelacimab Highlights & Side Effects. Trial Name: NCT04755283 — Phase 2
Abelacimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04755283 — Phase 2
Atrial Fibrillation Patient Testimony for trial: Trial Name: NCT04755283 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What indications usually warrant the administration of Abelacimab?

"Abelacimab is an efficacious remedy for venous thromboembolism, chronic coronary artery disease, and deep vein thrombosis."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
Alabama
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Anthos Investigative Site
How many prior treatments have patients received?
1

What questions have other patients asked about this trial?

Why did patients apply to this trial?

I am currently on Eliquis, but would like to explore if another medication would reduce bleeding risk.
PatientReceived 1 prior treatment
~294 spots leftby Mar 2025