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

Study acronym: AZALEA-TIMI 71
StatusActive, Not Recruiting
PhasePhase 2
Started2021-02-02
View on ClinicalTrials.gov ↗

Amendment history

2025-11-04
Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations, IPDSharing, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v36
Study sitesdetails revised at 3 of 92 sites
Collaborators2 to 1 entries
TheNovartis TIMI Study Group FortreaPharmaceuticals
2025-08-21
Study Status v35
Completion date2025-12→2028-12-29
2025-07-29
Study Status, Adverse Events v34
Results first postednot stated→2025-07-30
2025-06-27
Study Status, Outcome Measures, Outcome Measures (Results), Adverse Events v33
Secondary endpoints2 entries, revised
Incidence Rate of the First Occurrence of ISTH-defined Major Bleeding Events Incidence Rate of the First Occurrence of ISTH-defined Major or CRNM or Minor Bleeding Events
Primary endpoints1 entry, revised
Incidence Rate of the First Occurrence of Composite of International Society on Thrombosis and Haemostasis (ISTH)-Defined Major Bleeding or Clinically Relevant NonmajorNon-Major (CRNM) Bleeding Events
2025-05-15
Study Status, Outcome Measures, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, Limitations and Caveats v32
Secondary endpointsdetails revised at 2 of 2 entries
Show 31 earlier versions
2025-04-03
Study Status, Arms and Interventions, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, Limitations and Caveats, More Information v31
Study arms2→3
Secondary endpoints2 entries, revised
EvaluateMajor effectBleeding of abelacimab relative to rivaroxaban on the rate of major bleeding eventsEvents Evaluate the effect of abelacimab relative to rivaroxaban on the rate of majorMajor or minorMinor bleedingBleeding eventsEvents
Primary endpoints1 entry, revised
Evaluate effect of abelacimab relative to rivaroxaban on the rate of majorMajor or clinicallyClinically relevantRelevant non-majorNonmajor (CRNM) bleedingBleeding eventsEvents
2025-03-17
Study Identification, Study Status, Oversight, Study Design, Contacts/Locations, References v30
Enrollment targetestimated 1200→confirmed 1287
Study sitesdetails revised at 3 of 92 sites
Publicationsdetails revised at 1 of 4 entries
Study titlerevised
Safety and Tolerability of Abelacimab (MAA868) Vsvs. Rivaroxaban in Patients withWith Atrial Fibrillation
2025-01-21
Study Identification, Study Status, Oversight, Contacts/Locations v29
Primary completion date2023-12-14→2024-02-15
Study sitesdetails revised at 3 of 92 sites
Study titlerevised
Safety and Tolerability of Abelacimab (MAA868) vsVs. Rivaroxaban in Patients Withwith Atrial Fibrillation
2024-07-21
Study Status v28
Re-verified, no change to tracked fields
2024-06-07
Study Status, Contacts/Locations v27
Study sites83→92
2024-05-16
Study Status, Sponsor/Collaborators, Contacts/Locations v26
Completion date2025-01→2025-12
Study sites92→83
Collaborators2 entries, revised
Laboratory Corporation of AmericaFortrea
2024-03-15
Study Status, Contacts/Locations v25
Study sites93→92
2024-01-12
Study Status, Arms and Interventions, Contacts/Locations v24
Primary completion dateestimated 2023-12→confirmed 2023-12-14
Completion date2024-01→2025-01
Study sites94→93
2023-11-09
Study Status v23
Re-verified, no change to tracked fields
2023-01-25
Study Status v22
Primary completion date2023-01→2023-12
Completion date2023-05→2024-01
2022-05-16
Study Status, Sponsor/Collaborators, Eligibility, Contacts/Locations v21
Study sites95→94
Eligibility criteria+110 characters
[...] 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 thro [...]
Collaborators2 entries, revised
CovanceLaboratory Corporation of America
2021-12-14
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v20
Trial statusRecruiting→Active, Not Recruiting
Study sites118→95
2021-12-01
Study Status, Contacts/Locations v19
Study sitesdetails revised at 25 of 118 sites
2021-11-15
Study Status, Contacts/Locations v18
Study sitesdetails revised at 61 of 118 sites
2021-11-01
Study Status, Contacts/Locations v17
Study sites106→118
2021-10-14
Study Status, Contacts/Locations v16
Study sites100→106
2021-10-04
Study Status, Contacts/Locations v15
Study sites95→100
2021-09-16
Study Status, Contacts/Locations v14
Study sites89→95
2021-09-08
Study Status, Contacts/Locations v13
Study sites82→89
2021-08-20
Study Status, Contacts/Locations v12
Study sites77→82
2021-08-09
Study Status, Contacts/Locations v11
Study sites68→77
2021-07-22
Study Status, Contacts/Locations v10
Study sites58→68
2021-07-08
Study Status, Contacts/Locations v9
Study sites48→58
2021-06-25
Study Status, Contacts/Locations v8
Study sites29→48
2021-06-11
Study Status, Contacts/Locations v7
Study sites25→29
2021-05-28
Study Status, Contacts/Locations v6
Study sites20→25
2021-05-24
Study Status, Contacts/Locations v5
Study sites16→20
2021-05-03
Study Status, Contacts/Locations v4
Study sites10→16
2021-04-16
Study Status, Contacts/Locations v3
Study sites5→10
2021-03-19
Study Status, Contacts/Locations v2
Study sites3→5
2021-03-05
Study Status, Contacts/Locations v1
Study sites1→3
2021-02-11
Original filing
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.
Trial Details
NCT Number NCT04755283
Lead Sponsor Anthos Therapeutics, Inc.
Collaborators: Novartis Pharmaceuticals
Conditions Atrial Fibrillation (AF), Stroke
Enrollment 1,287 participants
Start Date 2021-02-02
Primary Completion 2024-02-15 (estimated)
Study Completion 2028-12-29 (estimated)
Updated on ClinicalTrials.gov 2025-11-06