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NCT04755283: AZALEA-TIMI 71

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

Active, enrolled Phase 2 Results posted Last updated 6 November 2025
What this trial tests

Phase 2 trial testing Abelacimab in Atrial Fibrillation (AF) in 1,287 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
2 February 2021
Primary endpoint
15 February 2024
29 December 2028

Quick facts

Lead sponsorAnthos Therapeutics, Inc.
PhasePhase 2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposesupportive care
Enrollment1,287
Start date2 February 2021
Primary completion15 February 2024
Estimated completion29 December 2028
Sites92 locations across Taiwan, Poland, Hungary, South Korea, Canada, United States, Czechia

Drugs / interventions tested

Conditions studied

Sponsor

Anthos Therapeutics, Inc. — full company profile →

Who can join

55 and older, any sex, with Atrial Fibrillation (AF) or Stroke. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · 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.

GroupValue95% CI
Abelacimab 90 mg (MAA868)2.64
Abelacimab 150 mg (MAA868)3.22
Rivaroxaban8.39
Incidence Rate of the First Occurrence of ISTH-defined Major Bleeding Events Secondary · 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.

GroupValue95% CI
Abelacimab 90 mg (MAA868)0.99
Abelacimab 150 mg (MAA868)1.22
Rivaroxaban3.73
Incidence Rate of the First Occurrence of ISTH-defined Major or CRNM or Minor Bleeding Events Secondary · 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.

GroupValue95% CI
Abelacimab 90 mg (MAA868)7.05
Abelacimab 150 mg (MAA868)10.43
Rivaroxaban15.30

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events (AEs) that started during or after the start of the treatment or started prior to the start of the treatment and increased in severity after the start of the treatment through each participant's derived End of Study date for the randomized period (up to 33 months).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Abelacimab 90 mg (MAA868)
Serious: 158/425 (37%)
Deaths: 31/427
Abelacimab 150 mg (MAA868)
Serious: 157/427 (37%)
Deaths: 36/430
Rivaroxaban
Serious: 167/428 (39%)
Deaths: 34/430

Serious adverse events (336 terms)

ReactionSystemAbelacimab 90 mg (MAA868)Abelacimab 150 mg (MAA868)Rivaroxaban
Cardiac failureCardiac disorders
Atrial fibrillationCardiac disorders
PneumoniaInfections and infestations
Gastrointestinal haemorrhageGastrointestinal disorders
AnaemiaBlood and lymphatic system disorders
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders
COVID-19 pneumoniaInfections and infestations
DeathGeneral disorders
Urinary tract infectionInfections and infestations
Acute myocardial infarctionCardiac disorders
Acute respiratory failureRespiratory, thoracic and mediastinal disorders
Ischaemic strokeNervous system disorders
Transient ischaemic attackNervous system disorders
Cardiac failure congestiveCardiac disorders
Acute kidney injuryRenal and urinary disorders
SepsisInfections and infestations
COVID-19Infections and infestations
Coronary artery diseaseCardiac disorders
CellulitisInfections and infestations
Cerebrovascular accidentNervous system disorders
Angina unstableCardiac disorders
Cardiac failure chronicCardiac disorders
Myocardial infarctionCardiac disorders
Inguinal herniaGastrointestinal disorders
OsteoarthritisMusculoskeletal and connective tissue disorders
Other adverse events (10 terms — click to expand)

ReactionSystemAbelacimab 90 mg (MAA868)Abelacimab 150 mg (MAA868)Rivaroxaban
COVID-19Infections and infestations
Atrial fibrillationCardiac disorders
ArthralgiaMusculoskeletal and connective tissue disorders
Urinary tract infectionInfections and infestations
ContusionInjury, poisoning and procedural complications
HeadacheNervous system disorders
EpistaxisRespiratory, thoracic and mediastinal disorders
HypertensionVascular disorders
Back painMusculoskeletal and connective tissue disorders
AnaemiaBlood and lymphatic system disorders

Most-reported serious reactions: Cardiac failure, Atrial fibrillation, Pneumonia, Gastrointestinal haemorrhage, Anaemia, Chronic obstructive pulmonary disease, COVID-19 pneumonia, Death.

Data from ClinicalTrials.gov NCT04755283 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Stroke genetics informs drug discovery and risk prediction across ancestries.
    Mishra A, Malik R, Hachiya T, Jürgenson T, et al · · 2022 · cited 481× · PMID 36180795 · DOI 10.1038/s41586-022-05165-3
  2. Abelacimab versus Rivaroxaban in Patients with Atrial Fibrillation.
    Ruff CT, Patel SM, Giugliano RP, Morrow DA, et al · · 2025 · cited 62× · PMID 39842011 · DOI 10.1056/nejmoa2406674
  3. Factor XI Inhibitors for Prevention and Treatment of Venous Thromboembolism: A Review on the Rationale and Update on Current Evidence.
    Nopp S, Kraemmer D, Ay C. · · 2022 · cited 61× · PMID 35647061 · DOI 10.3389/fcvm.2022.903029
  4. New pharmacological agents and novel cardiovascular pharmacotherapy strategies in 2022.
    Tamargo J, Agewall S, Borghi C, Ceconi C, et al · · 2023 · cited 25× · PMID 37169875 · DOI 10.1093/ehjcvp/pvad034
  5. Thromboinflammatory challenges in stroke pathophysiology.
    Szepanowski RD, Haupeltshofer S, Vonhof SE, Frank B, et al · · 2023 · cited 24× · PMID 37273022 · DOI 10.1007/s00281-023-00994-4
  6. Treatment of Cancer-Associated Thrombosis: Recent Advances, Unmet Needs, and Future Direction.
    Wang TF, Khorana AA, Agnelli G, Bloomfield D, et al · · 2023 · cited 23× · PMID 37171998 · DOI 10.1093/oncolo/oyad116
  7. New pharmacological agents and novel cardiovascular pharmacotherapy strategies in 2023.
    Tamargo J, Agewall S, Borghi C, Ceconi C, et al · · 2024 · cited 13× · PMID 38379024 · DOI 10.1093/ehjcvp/pvae013
  8. Factor XI Inhibitors: A New Horizon in Anticoagulation Therapy.
    Presume J, Ferreira J, Ribeiras R. · · 2024 · cited 13× · PMID 38306010 · DOI 10.1007/s40119-024-00352-x

Verify or expand the search:

Other trials of Abelacimab

Trials testing the same drug.

Other recruiting trials for Atrial Fibrillation (AF)

Currently open trials in the same condition.

Other Anthos Therapeutics, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04755283.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing