What is the mechanism of action of this treatment?

Common treatments for Atrial Fibrillation (AF) include anticoagulants and antiarrhythmic drugs. Anticoagulants like warfarin and direct oral anticoagulants (DOACs) such as rivaroxaban, and potentially abelacimab (a Factor XI inhibitor), prevent blood clots, thereby reducing the risk of stroke, a major concern in AF patients. Antiarrhythmic drugs like amiodarone, sotalol, and dofetilide work by altering the heart's electrical activity to maintain a normal sinus rhythm. These treatments are essential for managing AF symptoms and preventing serious complications, making the understanding of their mechanisms crucial for effective patient care.

What side effects are associated with this type of intervention?

Common treatments for Atrial Fibrillation (AF) include anticoagulants such as warfarin, direct oral anticoagulants (DOACs) like rivaroxaban, and potentially Factor XI inhibitors like Abelacimab. The primary side effect of these anticoagulants is an increased risk of bleeding, which can range from minor bruising to severe, life-threatening hemorrhages. Warfarin requires regular blood monitoring and dietary restrictions due to its narrow therapeutic window. DOACs, while not requiring frequent monitoring, can still cause gastrointestinal issues and have a risk of bleeding. Rivaroxaban, specifically, has been associated with a higher risk of gastrointestinal bleeding compared to some other DOACs.

What prior FDA approvals exist?

The FDA has approved several anticoagulants for the treatment of Atrial Fibrillation (AF). Notable among these are direct oral anticoagulants (DOACs) like rivaroxaban, which has been studied extensively for its efficacy in reducing stroke risk in AF patients. Rivaroxaban, often used in combination with aspirin, has shown significant benefits in reducing cardiovascular events. Other approved anticoagulants include warfarin, a vitamin K antagonist, which has been a long-standing treatment option for AF. The development of newer anticoagulants like Abelacimab, a likely Factor XI inhibitor, represents ongoing efforts to improve the safety and efficacy profiles of AF treatments.

What other types of research exist?

Promising novel alternatives to Abelacimab for atrial fibrillation patients include: 1) Rivaroxaban, a direct Factor Xa inhibitor, which has shown efficacy in stroke prevention and a manageable bleeding profile. 2) Apixaban, another direct Factor Xa inhibitor, known for its safety and efficacy in reducing stroke risk in AF patients. 3) Edoxaban, also a direct Factor Xa inhibitor, which offers a balance of efficacy and safety. These alternatives are well-studied and provide effective anticoagulation with a relatively low risk of major bleeding.

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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.

AZALEA-TIMI 71 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization through study completion, an average of 17 months

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.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Atrial Fibrillation (AF) include anticoagulants and antiarrhythmic drugs. Anticoagulants like warfarin and direct oral anticoagulants (DOACs) such as rivaroxaban, and potentially abelacimab (a Factor XI inhibitor), prevent blood clots, thereby reducing the risk of stroke, a major concern in AF patients. Antiarrhythmic drugs like amiodarone, sotalol, and dofetilide work by altering the heart's electrical activity to maintain a normal sinus rhythm. These treatments are essential for managing AF symptoms and preventing serious complications, making the understanding of their mechanisms crucial for effective patient care.