MedDataX Logo

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

NCT ID: NCT04755283

Last Updated: 2025-11-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

1287 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-02

Study Completion Date

2028-12-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation (AF) Stroke

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
All care providers are blinded with the exception of the pharmacist and study team member assigned to administer the subcutaneous injection of abelacimab.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Abelacimab 90 mg (MAA868)

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

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

Group Type EXPERIMENTAL

Abelacimab

Intervention Type BIOLOGICAL

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

Abelacimab 150 mg (MAA868)

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

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

Group Type EXPERIMENTAL

Abelacimab

Intervention Type BIOLOGICAL

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

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.

Group Type ACTIVE_COMPARATOR

Rivaroxaban

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Abelacimab

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

Intervention Type BIOLOGICAL

Rivaroxaban

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MAA868

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Anthos Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Anthos Investigative Site

Huntsville, Alabama, United States

Site Status

Anthos Investigative Site

Mobile, Alabama, United States

Site Status

Anthos Investigative Site

Stamford, Connecticut, United States

Site Status

Anthos Investigative Site

Clearwater, Florida, United States

Site Status

Anthos Investigative Site

Daytona Beach, Florida, United States

Site Status

Anthos Investigative Site

Largo, Florida, United States

Site Status

Anthos Investigative Site

Safety Harbor, Florida, United States

Site Status

Anthos Investigative Site

Saint Augustine, Florida, United States

Site Status

Anthos Investigative Site

Johns Creek, Georgia, United States

Site Status

Anthos Investigative Site

Owensboro, Kentucky, United States

Site Status

Anthos Investigative Site

Baltimore, Maryland, United States

Site Status

Anthos Investigative Site

Salisbury, Maryland, United States

Site Status

Anthos Investigative Site

Framingham, Massachusetts, United States

Site Status

Anthos Investigative Site

Haverhill, Massachusetts, United States

Site Status

Anthos Investigative Site

Lansing, Michigan, United States

Site Status

Anthos Investigative Site

Sewell, New Jersey, United States

Site Status

Anthos Investigative Site

Poughkeepsie, New York, United States

Site Status

Anthos Investigative Site

Southampton, New York, United States

Site Status

Anthos Investigative Site

Lenoir, North Carolina, United States

Site Status

Anthos Investigative Site

Fargo, North Dakota, United States

Site Status

Anthos Investigative Site

Oklahoma City, Oklahoma, United States

Site Status

Anthos Investigative Site

Camp Hill, Pennsylvania, United States

Site Status

Anthos Investigative Site

Kingsport, Tennessee, United States

Site Status

Anthos Investigative Site

Kingwood, Texas, United States

Site Status

Anthos Investigative Site

Odessa, Texas, United States

Site Status

Anthos Investigative Site

Tomball, Texas, United States

Site Status

Anthos Investigative Site

Falls Church, Virginia, United States

Site Status

Anthos Investigative Site

Manassas, Virginia, United States

Site Status

Anthos Investigative Site

Cambridge, Ontario, Canada

Site Status

Anthos Investigative Site

Greater Sudbury, Ontario, Canada

Site Status

Anthos Investigative Site

Oshawa, Ontario, Canada

Site Status

Anthos Investigative Site

Greenfield Park, Quebec, Canada

Site Status

Anthos Investigative Site

Montreal, Quebec, Canada

Site Status

Anthos Investigative Site

Brandýs nad Labem, Central Bohemia, Czechia

Site Status

Anthos Investigative Site

Poděbrady, Central Bohemia, Czechia

Site Status

Anthos Investigative Site

Příbram, Central Bohemia, Czechia

Site Status

Anthos Investigative Site

Slaný, Central Bohemia, Czechia

Site Status

Anthos Investigative Site

Mariánské Lázně, KA, Czechia

Site Status

Anthos Investigative Site

Trutnov, KR, Czechia

Site Status

Anthos Investigative Site

Liberec, LB, Czechia

Site Status

Anthos Investigative Site

Česká Lípa, LI, Czechia

Site Status

Anthos Investigative Site

Liberec, LI, Czechia

Site Status

Anthos Investigative Site

Pardubice, PA, Czechia

Site Status

Anthos Investigative Site

Prague, PR, Czechia

Site Status

Anthos Investigative Site

Prague, PR, Czechia

Site Status

Anthos Investigative Site

Prague, PR, Czechia

Site Status

Anthos Investigative Site

Kroměříž, ZL, Czechia

Site Status

Anthos Investigative Site

Holešov, Zlín, Czechia

Site Status

Anthos Investigative Site

Orosháza, BE, Hungary

Site Status

Anthos Investigative Site

Baja, BK, Hungary

Site Status

Anthos Investigative Site

Budapest, BP, Hungary

Site Status

Anthos Investigative Site

Budapest, BP, Hungary

Site Status

Anthos Investigative Site

Budapest, BU, Hungary

Site Status

Anthos Investigative Site

Budapest, BU, Hungary

Site Status

Anthos Investigative Site

Székesfehérvár, FE, Hungary

Site Status

Anthos Investigative Site

Debrecen, HB, Hungary

Site Status

Anthos Investigative Site

Kaposvár, SO, Hungary

Site Status

Anthos Investigative Site (4002)

Nyíregyháza, SZ, Hungary

Site Status

Anthos Investigative Site (4003)

Nyíregyháza, SZ, Hungary

Site Status

Anthos Investigative Site

Balatonfüred, VE, Hungary

Site Status

Anthos Investigative Site

Balatonfüred, VM, Hungary

Site Status

Anthos Investigative Site

Gdynia, GDY, Poland

Site Status

Anthos Investigative Site

Chrzanów, Lesser Poland Voivodeship, Poland

Site Status

Anthos Investigative Site

Krakow, Lesser Poland Voivodeship, Poland

Site Status

Anthos Investigative Site

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status

Anthos Investigative Site

Żarów, Lower Silesian Voivodeship, Poland

Site Status

Anthos Investigative Site

Lublin, Lublin Voivodeship, Poland

Site Status

Anthos Investigative Site

Zamość, Lubusz Voivodeship, Poland

Site Status

Anthos Investigative Site

Płock, Masovian Voivodeship, Poland

Site Status

Anthos Investigative Site

Warsaw, Masovian Voivodeship, Poland

Site Status

Anthos Investigative Site

Warsaw, Masovian Voivodeship, Poland

Site Status

Anthos Investigative Site

Przemyśl, Podkarpackie Voivodeship, Poland

Site Status

Anthos Investigative Site

Gdynia, Pomeranian Voivodeship, Poland

Site Status

Anthos Investigative Site

Bielsko-Biala, Silesian Voivodeship, Poland

Site Status

Anthos Investigative Site

Dąbrowa Górnicza, Silesian Voivodeship, Poland

Site Status

Anthos Investigative Site

Ruda Śląska, Silesian Voivodeship, Poland

Site Status

Anthos Investigative Site

Tychy, Silesian Voivodeship, Poland

Site Status

Anthos Investigative Site

Elblag, Warmian-Masurian Voivodeship, Poland

Site Status

Anthos Investigative Site

Lodz, Łódź Voivodeship, Poland

Site Status

Anthos Investigative Site

Seogu, Busan, South Korea

Site Status

Anthos Investigative Site

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Anthos Investigative Site

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Anthos Investigative Site

Seoul, Seoul, South Korea

Site Status

Anthos Investigative Site

Seoul, Seoul, South Korea

Site Status

Anthos Investigative Site

Seoul, Seoul, South Korea

Site Status

Anthos Investigative Site

Taipei, HSZ, Taiwan

Site Status

Anthos Investigative Site

Hualien City, HUA, Taiwan

Site Status

Anthos Investigative Site

Yilan, ILA, Taiwan

Site Status

Anthos Investigative Site

Kaohsiung City, KHH, Taiwan

Site Status

Anthos Investigative Site

Taipei, TPE, Taiwan

Site Status

Anthos Investigative Site

Taipei, TPE, Taiwan

Site Status

Anthos Investigative Site

Tiachung, TXG, Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada Czechia Hungary Poland South Korea Taiwan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 39842011 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40546068 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-004507-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CMAA868A2204

Identifier Type: OTHER

Identifier Source: secondary_id

ANT-006

Identifier Type: -

Identifier Source: org_study_id