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

NCT04755283 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 3 other identifiers: ANT-0062020-004507-13CMAA868A2204
• Study Type: interventional
• Target: 1,287
• Locations: 7 countries
• Sites: 92

Brief Summary

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.

Conditions

Atrial Fibrillation (AF); Stroke

Keywords

randomized; prospective; blinded endpoint evaluation; abelacimab; MAA868; rivaroxaban; atrial fibrillation; Factor XI; stroke; bleeding events; anti-coagulant; anticoagulation therapy

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (2)

• Incidence Rate of the First Occurrence of ISTH-defined Major Bleeding Events

  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

  Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months.

Study Arms (3)

Abelacimab 90 mg (MAA868)

EXPERIMENTAL

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

Biological: Abelacimab

Abelacimab 150 mg (MAA868)

EXPERIMENTAL

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

Biological: Abelacimab

Rivaroxaban

ACTIVE COMPARATOR

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

Interventions

Abelacimab BIOLOGICAL

Abelacimab provided as liquid in vial (150 mg/mL)

Also known as: MAA868

Abelacimab 150 mg (MAA868); Abelacimab 90 mg (MAA868)

Rivaroxaban DRUG

Rivaroxaban 15 mg and 20 mg provided as commercially available film-coated tablets

Rivaroxaban

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anthos Therapeutics, Inc.: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (92)

Anthos Investigative Site

Huntsville, Alabama, 35801, United States

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Mobile, Alabama, 36608, United States

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Stamford, Connecticut, 06905, United States

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Clearwater, Florida, 33756, United States

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Daytona Beach, Florida, 32114-2321, United States

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Largo, Florida, 33777, United States

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Safety Harbor, Florida, 34695, United States

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Saint Augustine, Florida, 32086, United States

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Johns Creek, Georgia, 30024, United States

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Owensboro, Kentucky, 42303, United States

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Baltimore, Maryland, 21229-5222, United States

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Salisbury, Maryland, 21804, United States

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Framingham, Massachusetts, 01701, United States

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Haverhill, Massachusetts, 01830, United States

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Lansing, Michigan, 48912, United States

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Sewell, New Jersey, 08080, United States

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Poughkeepsie, New York, 12601, United States

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Southampton, New York, 11968, United States

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Lenoir, North Carolina, 28645, United States

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Fargo, North Dakota, 58104, United States

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Oklahoma City, Oklahoma, 73135, United States

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Camp Hill, Pennsylvania, 17011, United States

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Kingsport, Tennessee, 37660, United States

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Kingwood, Texas, 77339, United States

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Odessa, Texas, 79761-5133, United States

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Tomball, Texas, 77375, United States

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Falls Church, Virginia, 22042, United States

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Manassas, Virginia, 20109, United States

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Cambridge, Ontario, N1R 7R1, Canada

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Greater Sudbury, Ontario, P3B 4H5, Canada

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Oshawa, Ontario, L1J2K1, Canada

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Greenfield Park, Quebec, J4V 2G8, Canada

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Montreal, Quebec, H1T 3Y7, Canada

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Brandýs nad Labem, Central Bohemia, 250 01, Czechia

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Poděbrady, Central Bohemia, 29001, Czechia

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Příbram, Central Bohemia, 261 01, Czechia

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Slaný, Central Bohemia, 274 01, Czechia

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Mariánské Lázně, KA, 353 01, Czechia

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Trutnov, KR, 541 01, Czechia

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Liberec, LB, 460 01, Czechia

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Česká Lípa, LI, 470 01, Czechia

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Liberec, LI, 460 01, Czechia

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Pardubice, PA, 530 02, Czechia

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Prague, PR, 10100, Czechia

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Prague, PR, 110 00, Czechia

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Prague, PR, 158 00, Czechia

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Kroměříž, ZL, 767 01, Czechia

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Holešov, Zlín, 769 01, Czechia

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Orosháza, BE, 5900, Hungary

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Baja, BK, 6500, Hungary

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Budapest, BP, 1036, Hungary

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Budapest, BP, 1122, Hungary

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Budapest, BU, 1033, Hungary

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Budapest, BU, 1134, Hungary

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Székesfehérvár, FE, 8000, Hungary

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Debrecen, HB, 4025, Hungary

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Kaposvár, SO, 7400, Hungary

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Anthos Investigative Site (4002)

Nyíregyháza, SZ, 4400, Hungary

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Anthos Investigative Site (4003)

Nyíregyháza, SZ, 4400, Hungary

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Balatonfüred, VE, 8230, Hungary

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Balatonfüred, VM, 8230, Hungary

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Gdynia, GDY, 81-423, Poland

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Chrzanów, Lesser Poland Voivodeship, 32-500, Poland

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Krakow, Lesser Poland Voivodeship, 31-202, Poland

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Wroclaw, Lower Silesian Voivodeship, 51-162, Poland

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Żarów, Lower Silesian Voivodeship, 58-130, Poland

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Lublin, Lublin Voivodeship, 20-001, Poland

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Zamość, Lubusz Voivodeship, 22-400, Poland

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Płock, Masovian Voivodeship, 09-402, Poland

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Warsaw, Masovian Voivodeship, 02-097, Poland

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Warsaw, Masovian Voivodeship, 04-628, Poland

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Przemyśl, Podkarpackie Voivodeship, 37-700, Poland

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Gdynia, Pomeranian Voivodeship, 81-157, Poland

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Bielsko-Biala, Silesian Voivodeship, 43-316, Poland

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Dąbrowa Górnicza, Silesian Voivodeship, 41-300, Poland

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Ruda Śląska, Silesian Voivodeship, 41-710, Poland

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Tychy, Silesian Voivodeship, 43-100, Poland

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Elblag, Warmian-Masurian Voivodeship, 82-300, Poland

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Lodz, Łódź Voivodeship, 92-213, Poland

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Seogu, Busan, 49201, South Korea

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Anthos Investigative Site

Seongnam-si, Gyeonggi-do, 13496, South Korea

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Seongnam-si, Gyeonggi-do, 13620, South Korea

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Seoul, Seoul, 158-710, South Korea

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Seoul, Seoul, 3080, South Korea

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Seoul, Seoul, 3722, South Korea

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Taipei, HSZ, 30071, Taiwan

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Hualien City, HUA, 970, Taiwan

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Yilan, ILA, 26058, Taiwan

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Kaohsiung City, KHH, 807, Taiwan

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Taipei, TPE, 11217, Taiwan

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Anthos Investigative Site

Taipei, TPE, 116, Taiwan

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Anthos Investigative Site

Tiachung, TXG, 404, Taiwan

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Related Publications (3)

• Ruff CT, Patel SM, Giugliano RP, Morrow DA, Hug B, Kuder JF, Goodrich EL, Chen SA, Goodman SG, Joung B, Kiss RG, Spinar J, Wojakowski W, Weitz JI, Murphy SA, Wiviott SD, Parkar S, Bloomfield D, Sabatine MS; AZALEA-TIMI 71 Investigators. Abelacimab versus Rivaroxaban in Patients with Atrial Fibrillation. N Engl J Med. 2025 Jan 23;392(4):361-371. doi: 10.1056/NEJMoa2406674.

  PMID: 39842011 RESULT

• Al Said S, Patel SM, Giugliano RP, Morrow DA, Goodrich EL, Murphy SA, Hug B, Parkar S, Chen SA, Goodman SG, Joung B, Kiss RG, Wojakowski W, Weitz JI, Bloomfield D, Sabatine MS, Ruff CT. Abelacimab vs Rivaroxaban in Older Individuals With Atrial Fibrillation: A Prespecified Analysis of the Phase 2b AZALEA-TIMI 71 Trial. JAMA Cardiol. 2026 Feb 4:e255418. doi: 10.1001/jamacardio.2025.5418. Online ahead of print.

  PMID: 41637102 DERIVED

• Al Said S, Patel SM, Giugliano RP, Morrow DA, Goodrich EL, Murphy SA, Hug B, Parkar S, Chen SA, Goodman SG, Joung B, Kiss RG, Wojakowski W, Weitz JI, Bloomfield D, Sabatine MS, Ruff CT. Abelacimab Versus Rivaroxaban in Patients With Atrial Fibrillation on Antiplatelet Therapy: A Prespecified Analysis of the AZALEA-TIMI 71 Trial. Circulation. 2025 Aug 5;152(5):290-296. doi: 10.1161/CIRCULATIONAHA.125.074037. Epub 2025 Jun 23.

  PMID: 40546068 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Interventions

abelacimab; MAA868; Rivaroxaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The independent data monitoring committee recommended early termination of the trial on September 14, 2023.

Results Point of Contact

• Title: Study Director
• Organization: Anthos Therapeutics, a Novartis company

Novartis.email@Novartis.com

+1-888-669-6682

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: All care providers are blinded with the exception of the pharmacist and study team member assigned to administer the subcutaneous injection of abelacimab.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an event-driven, randomized, active-controlled, blinded endpoint, parallel-group study to evaluate the effect of two blinded doses of abelacimab relative to open-label rivaroxaban on the rate of major or clinically relevant non-major (CRNM) bleeding events in patients with atrial fibrillation (AF) who are at moderate-to-high risk of stroke.

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 16, 2021
• Study Start: February 2, 2021
• Primary Completion: February 15, 2024
• Study Completion (Estimated): December 29, 2028
• Last Updated: November 6, 2025
• Results First Posted: July 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

CZ (15); HU (13); US (28); CA (5); KR (6); TW (7); PL (18)