Safety and Tolerability of Abelacimab (MAA868) vs. Rivaroxaban in Patients With Atrial Fibrillation (AZALEA-TIMI 71)

November 4, 2025 updated by: Anthos Therapeutics, Inc.

A Multicenter, RandomiZed, Active-ControLled Study to Evaluate the Safety and Tolerability of Two Blinded Doses of Abelacimab (MAA868) Compared With Open-Label Rivaroxaban in Patients With Atrial Fibrillation (AZALEA)

The purpose of the ANT-006 study is to evaluate the bleeding profile of abelacimab relative to rivaroxaban in patients with atrial fibrillation (AF) at moderate-to-high risk of stroke.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1287

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Cambridge, Ontario, Canada, N1R 7R1
        • Anthos Investigative Site
      • Greater Sudbury, Ontario, Canada, P3B 4H5
        • Anthos Investigative Site
      • Oshawa, Ontario, Canada, L1J2K1
        • Anthos Investigative Site
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2G8
        • Anthos Investigative Site
      • Montreal, Quebec, Canada, H1T 3Y7
        • Anthos Investigative Site
  • Czechia
    • Central Bohemia
      • Brandýs nad Labem, Central Bohemia, Czechia, 250 01
        • Anthos Investigative Site
      • Poděbrady, Central Bohemia, Czechia, 29001
        • Anthos Investigative Site
      • Příbram, Central Bohemia, Czechia, 261 01
        • Anthos Investigative Site
      • Slaný, Central Bohemia, Czechia, 274 01
        • Anthos Investigative Site
    • KA
      • Mariánské Lázně, KA, Czechia, 353 01
        • Anthos Investigative Site
    • KR
      • Trutnov, KR, Czechia, 541 01
        • Anthos Investigative Site
    • LB
      • Liberec, LB, Czechia, 460 01
        • Anthos Investigative Site
    • LI
      • Liberec, LI, Czechia, 460 01
        • Anthos Investigative Site
      • Česká Lípa, LI, Czechia, 470 01
        • Anthos Investigative Site
    • PA
      • Pardubice, PA, Czechia, 530 02
        • Anthos Investigative Site
    • PR
      • Prague, PR, Czechia, 10100
        • Anthos Investigative Site
      • Prague, PR, Czechia, 110 00
        • Anthos Investigative Site
      • Prague, PR, Czechia, 158 00
        • Anthos Investigative Site
    • ZL
      • Kroměříž, ZL, Czechia, 767 01
        • Anthos Investigative Site
    • Zlín
      • Holešov, Zlín, Czechia, 769 01
        • Anthos Investigative Site
  • Hungary
    • BE
      • Orosháza, BE, Hungary, 5900
        • Anthos Investigative Site
    • BK
      • Baja, BK, Hungary, 6500
        • Anthos Investigative Site
    • BP
      • Budapest, BP, Hungary, 1036
        • Anthos Investigative Site
      • Budapest, BP, Hungary, 1122
        • Anthos Investigative Site
    • BU
      • Budapest, BU, Hungary, 1033
        • Anthos Investigative Site
      • Budapest, BU, Hungary, 1134
        • Anthos Investigative Site
    • FE
      • Székesfehérvár, FE, Hungary, 8000
        • Anthos Investigative Site
    • HB
      • Debrecen, HB, Hungary, 4025
        • Anthos Investigative Site
    • SO
      • Kaposvár, SO, Hungary, 7400
        • Anthos Investigative Site
    • SZ
      • Nyíregyháza, SZ, Hungary, 4400
        • Anthos Investigative Site (4002)
      • Nyíregyháza, SZ, Hungary, 4400
        • Anthos Investigative Site (4003)
    • VE
      • Balatonfüred, VE, Hungary, 8230
        • Anthos Investigative Site
    • VM
      • Balatonfüred, VM, Hungary, 8230
        • Anthos Investigative Site
  • Poland
    • GDY
      • Gdynia, GDY, Poland, 81-423
        • Anthos Investigative Site
    • Lesser Poland Voivodeship
      • Chrzanów, Lesser Poland Voivodeship, Poland, 32-500
        • Anthos Investigative Site
      • Krakow, Lesser Poland Voivodeship, Poland, 31-202
        • Anthos Investigative Site
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 51-162
        • Anthos Investigative Site
      • Żarów, Lower Silesian Voivodeship, Poland, 58-130
        • Anthos Investigative Site
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-001
        • Anthos Investigative Site
    • Lubusz Voivodeship
      • Zamość, Lubusz Voivodeship, Poland, 22-400
        • Anthos Investigative Site
    • Masovian Voivodeship
      • Płock, Masovian Voivodeship, Poland, 09-402
        • Anthos Investigative Site
      • Warsaw, Masovian Voivodeship, Poland, 02-097
        • Anthos Investigative Site
      • Warsaw, Masovian Voivodeship, Poland, 04-628
        • Anthos Investigative Site
    • Podkarpackie Voivodeship
      • Przemyśl, Podkarpackie Voivodeship, Poland, 37-700
        • Anthos Investigative Site
    • Pomeranian Voivodeship
      • Gdynia, Pomeranian Voivodeship, Poland, 81-157
        • Anthos Investigative Site
    • Silesian Voivodeship
      • Bielsko-Biala, Silesian Voivodeship, Poland, 43-316
        • Anthos Investigative Site
      • Dąbrowa Górnicza, Silesian Voivodeship, Poland, 41-300
        • Anthos Investigative Site
      • Ruda Śląska, Silesian Voivodeship, Poland, 41-710
        • Anthos Investigative Site
      • Tychy, Silesian Voivodeship, Poland, 43-100
        • Anthos Investigative Site
    • Warmian-Masurian Voivodeship
      • Elblag, Warmian-Masurian Voivodeship, Poland, 82-300
        • Anthos Investigative Site
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 92-213
        • Anthos Investigative Site
  • South Korea
    • Busan
      • Seogu, Busan, South Korea, 49201
        • Anthos Investigative Site
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13496
        • Anthos Investigative Site
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Anthos Investigative Site
    • Seoul
      • Seoul, Seoul, South Korea, 158-710
        • Anthos Investigative Site
      • Seoul, Seoul, South Korea, 3080
        • Anthos Investigative Site
      • Seoul, Seoul, South Korea, 3722
        • Anthos Investigative Site
  • Taiwan
    • HSZ
      • Taipei, HSZ, Taiwan, 30071
        • Anthos Investigative Site
    • HUA
      • Hualien City, HUA, Taiwan, 970
        • Anthos Investigative Site
    • ILA
      • Yilan, ILA, Taiwan, 26058
        • Anthos Investigative Site
    • KHH
      • Kaohsiung City, KHH, Taiwan, 807
        • Anthos Investigative Site
    • TPE
      • Taipei, TPE, Taiwan, 11217
        • Anthos Investigative Site
      • Taipei, TPE, Taiwan, 116
        • Anthos Investigative Site
    • TXG
      • Tiachung, TXG, Taiwan, 404
        • Anthos Investigative Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Anthos Investigative Site
      • Mobile, Alabama, United States, 36608
        • Anthos Investigative Site
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Anthos Investigative Site
    • Florida
      • Clearwater, Florida, United States, 33756
        • Anthos Investigative Site
      • Daytona Beach, Florida, United States, 32114-2321
        • Anthos Investigative Site
      • Largo, Florida, United States, 33777
        • Anthos Investigative Site
      • Safety Harbor, Florida, United States, 34695
        • Anthos Investigative Site
      • Saint Augustine, Florida, United States, 32086
        • Anthos Investigative Site
    • Georgia
      • Johns Creek, Georgia, United States, 30024
        • Anthos Investigative Site
    • Kentucky
      • Owensboro, Kentucky, United States, 42303
        • Anthos Investigative Site
    • Maryland
      • Baltimore, Maryland, United States, 21229-5222
        • Anthos Investigative Site
      • Salisbury, Maryland, United States, 21804
        • Anthos Investigative Site
    • Massachusetts
      • Framingham, Massachusetts, United States, 01701
        • Anthos Investigative Site
      • Haverhill, Massachusetts, United States, 01830
        • Anthos Investigative Site
    • Michigan
      • Lansing, Michigan, United States, 48912
        • Anthos Investigative Site
    • New Jersey
      • Sewell, New Jersey, United States, 08080
        • Anthos Investigative Site
    • New York
      • Poughkeepsie, New York, United States, 12601
        • Anthos Investigative Site
      • Southampton, New York, United States, 11968
        • Anthos Investigative Site
    • North Carolina
      • Lenoir, North Carolina, United States, 28645
        • Anthos Investigative Site
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Anthos Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73135
        • Anthos Investigative Site
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Anthos Investigative Site
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Anthos Investigative Site
    • Texas
      • Kingwood, Texas, United States, 77339
        • Anthos Investigative Site
      • Odessa, Texas, United States, 79761-5133
        • Anthos Investigative Site
      • Tomball, Texas, United States, 77375
        • Anthos Investigative Site
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Anthos Investigative Site
      • Manassas, Virginia, United States, 20109
        • Anthos Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and female patients ≥ 55 years old
  • Patients with a history of atrial fibrillation (AF) or atrial flutter with planned indefinite anticoagulation

  • Patients with a CHA2DS2-VASc of ≥4 OR a CHA2DS2-VASc of ≥3 with at least 1 of the following:

    1. Planned concomitant use of antiplatelet medication use (i.e., aspirin and/or P2Y12 inhibitor) for the duration of the trial
    2. Creatinine Clearance (CrCl) ≤50 ml/min by the Cockcroft-Gault equation

Exclusion Criteria:

  • History of hypersensitivity to any of the study drugs (including rivaroxaban) or its excipients, to drugs of similar chemical classes, or any contraindication listed in the label for rivaroxaban
  • Patients with an intracranial or intraocular bleed within the 3 months prior to screening
  • Clinically significant mitral stenosis (valve area <1.5 cm2)
  • Mechanical heart valve or other indication for anticoagulation therapy other than atrial fibrillation (e.g., venous thromboembolism)
  • Known presence of an atrial myxoma or left ventricular thrombus
  • History of left atrial appendage closure or removal
  • Active endocarditis

Other protocol defined Inclusion/Exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rivaroxaban

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.
Drug: Rivaroxaban
Rivaroxaban 15 mg and 20 mg provided as commercially available film-coated tablets
Experimental: Abelacimab 90 mg (MAA868)

Treatment group 1: Abelacimab low dose subcutaneous (s.c.) monthly

Extension Treatment Group: Abelacimab high dose subcutaneous (s.c.) monthly
Biological: Abelacimab
Abelacimab provided as liquid in vial (150 mg/mL)
Other Names:
  • MAA868
Experimental: Abelacimab 150 mg (MAA868)

Treatment group 2: Abelacimab high dose subcutaneous (s.c.) monthly

Extension Treatment Group: Abelacimab high dose subcutaneous (s.c.) monthly
Biological: Abelacimab
Abelacimab provided as liquid in vial (150 mg/mL)
Other Names:
  • MAA868

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence Rate of the First Occurrence of Composite of International Society on Thrombosis and Haemostasis (ISTH)-Defined Major Bleeding or Clinically Relevant Non-Major (CRNM) Bleeding Events
Time Frame: Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months.
The number of participants experiencing the first occurrence of the composite of ISTH-defined major bleeding or CRNM bleeding events divided by the number of 100 person-years through the first event or end of treatment across all participants, is presented. For participants not experiencing events, person-years is calculated through the end of treatment during the randomized phase.
Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence Rate of the First Occurrence of ISTH-defined Major Bleeding Events
Time Frame: Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months.
The number of participants experiencing the first occurrence of ISTH-defined major bleeding events divided by the number of 100 person-years through the first event or end of treatment across all participants, is presented. For participants not experiencing events, person-years is calculated through the end of treatment during the randomized phase.
Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months.
Incidence Rate of the First Occurrence of ISTH-defined Major or CRNM or Minor Bleeding Events
Time Frame: Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months.
The number of participants experiencing the first occurrence of the composite of ISTH-defined major or CRNM or minor bleeding events divided by the number of 100 person-years through the first event or end of treatment across all participants, is presented. For participants not experiencing events, person-years is calculated through the end of treatment during the randomized phase.
Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anthos Therapeutics, Inc.

Collaborators

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2021

Primary Completion (Actual)

February 15, 2024

Study Completion (Estimated)

December 29, 2028

Study Registration Dates

First Submitted

February 11, 2021

First Submitted That Met QC Criteria

February 11, 2021

First Posted (Actual)

February 16, 2021

Study Record Updates

Last Update Posted (Estimated)

November 6, 2025

Last Update Submitted That Met QC Criteria

November 4, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANT-006
  • 2020-004507-13 (EudraCT Number)
  • CMAA868A2204 (Other Identifier: Novartis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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