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

Sponsor
Anthos Therapeutics, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04755283
Collaborator
The TIMI Study Group (Other), Laboratory Corporation of America (Industry)
1,200
Enrollment
94
Locations
2
Arms
26.9
Anticipated Duration (Months)
12.8
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
All care providers are blinded with the exception of the pharmacist and study team member assigned to administer the subcutaneous injection of abelacimab.
Primary Purpose:
Supportive Care
Official Title:
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)
Actual Study Start Date :
Feb 2, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Abelacimab (MAA868)

Treatment group 1: Abelacimab middle dose subcutaneous (s.c.) monthly Treatment group 2: Abelacimab high dose subcutaneous (s.c.) monthly

Biological: Abelacimab
Abelacimab provided as liquid in vial (150 mg/mL)
Other Names:
  • MAA868

    		•
    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

    Outcome Measures

    Primary Outcome Measures

    1. Evaluate effect of abelacimab relative to rivaroxaban on the rate of major or clinically relevant non-major (CRNM) bleeding events [From randomization through study completion, an average of 17 months]

      Time to first event of composite of International Society on Thrombosis and Haemostasis (ISTH)-defined major bleeding or CRNM bleeding events

    Secondary Outcome Measures

    1. Evaluate effect of abelacimab relative to rivaroxaban on the rate of major bleeding events [From randomization through study completion, an average of 17 months]

      Time to first event ISTH-defined major bleeding events

    2. Evaluate the effect of abelacimab relative to rivaroxaban on the rate of major or minor bleeding events [From randomization through study completion, an average of 17 months]

      Time to first event ISTH-defined major or minor bleeding events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anthos Investigative Site Huntsville Alabama United States 35801
    2 Anthos Investigative Site Mobile Alabama United States 36608
    3 Anthos Investigative Site Stamford Connecticut United States 06905
    4 Anthos Investigative Site Clearwater Florida United States 33756
    5 Anthos Investigative Site Daytona Beach Florida United States 32114-2321
    6 Anthos Investigative Site Largo Florida United States 33777
    7 Anthos Investigative Site Safety Harbor Florida United States 34695
    8 Anthos Investigative Site Saint Augustine Florida United States 32086
    9 Anthos Investigative Site Johns Creek Georgia United States 30024
    10 Anthos Investigative Site Owensboro Kentucky United States 42303
    11 Anthos Investigative Site Baltimore Maryland United States 21229-5222
    12 Anthos Investigative Site Salisbury Maryland United States 21804
    13 Anthos Investigative Site Framingham Massachusetts United States 01701
    14 Anthos Investigative Site Haverhill Massachusetts United States 01830
    15 Anthos Investigative Site Lansing Michigan United States 48912
    16 Anthos Investigative Site Sewell New Jersey United States 08080
    17 Anthos Investigative Site Poughkeepsie New York United States 12601
    18 Anthos Investigative Site Southampton New York United States 11968
    19 Anthos Investigative Site Lenoir North Carolina United States 28645
    20 Anthos Investigative Site Fargo North Dakota United States 58104
    21 Anthos Investigative Site Oklahoma City Oklahoma United States 73135
    22 Anthos Investigative Site Camp Hill Pennsylvania United States 17011
    23 Anthos Investigative Site Kingsport Tennessee United States 37660
    24 Anthos Investigative Site Kingwood Texas United States 77339
    25 Anthos Investigative Site Odessa Texas United States 79761-5133
    26 Anthos Investigative Site Tomball Texas United States 77375
    27 Anthos Investigative Site Falls Church Virginia United States 22042
    28 Anthos Investigative Site Manassas Virginia United States 20109
    29 Anthos Investigative Site New Westminster British Columbia Canada V3L 3W5
    30 Anthos Investigative Site Cambridge Ontario Canada N1R 7R1
    31 Anthos Investigative Site Oshawa Ontario Canada L1J2K1
    32 Anthos Investigative Site Sudbury Ontario Canada P3B 4H5
    33 Anthos Investigative Site Greenfield Park Quebec Canada J4V 2G8
    34 Anthos Investigative Site Montréal Quebec Canada H1T 3Y7
    35 Anthos Investigative Site Mariánské Lázně KA Czechia 353 01
    36 Anthos Investigative Site Trutnov KR Czechia 541 01
    37 Anthos Investigative Site Liberec LB Czechia 460 01
    38 Anthos Investigative Site Liberec LI Czechia 460 01
    39 Anthos Investigative Site Česká Lípa LI Czechia 470 01
    40 Anthos Investigative Site Pardubice PA Czechia 530 02
    41 Anthos Investigative Site Praha PR Czechia 10100
    42 Anthos Investigative Site Praha PR Czechia 110 00
    43 Anthos Investigative Site Praha PR Czechia 158 00
    44 Anthos Investigative Site Brandýs Nad Labem Středočeský Kraj Czechia 250 01
    45 Anthos Investigative Site Poděbrady Středočeský Kraj Czechia 29001
    46 Anthos Investigative Site Příbram Středočeský Kraj Czechia 261 01
    47 Anthos Investigative Site Slaný Středočeský Kraj Czechia 274 01
    48 Anthos Investigative Site Kroměříž ZL Czechia 767 01
    49 Anthos Investigative Site Holešov Zlín Czechia 769 01
    50 Anthos Investigative Site Orosháza BE Hungary 5900
    51 Anthos Investigative Site Baja BK Hungary 6500
    52 Anthos Investigative Site Budapest BP Hungary 1036
    53 Anthos Investigative Site Budapest BP Hungary 1122
    54 Anthos Investigative Site Budapest BU Hungary 1033
    55 Anthos Investigative Site Budapest BU Hungary 1134
    56 Anthos Investigative Site Székesfehérvár FE Hungary 8000
    57 Anthos Investigative Site Debrecen HB Hungary 4025
    58 Anthos Investigative Site Kaposvár SO Hungary 7400
    59 Anthos Investigative Site (4002) Nyíregyháza SZ Hungary 4400
    60 Anthos Investigative Site (4003) Nyíregyháza SZ Hungary 4400
    61 Anthos Investigative Site Balatonfüred VE Hungary 8230
    62 Anthos Investigative Site Balatonfüred VM Hungary 8230
    63 Anthos Investigative Site Seogu Busan Korea, Republic of 49201
    64 Anthos Investigative Site Seongnam-si Gyeonggi Korea, Republic of 13496
    65 Anthos Investigative Site Seongnam-si Gyeonggi Korea, Republic of 13620
    66 Anthos Investigative Site Seoul Korea, Republic of 158-710
    67 Anthos Investigative Site Seoul Korea, Republic of 3080
    68 Anthos Investigative Site Seoul Korea, Republic of 3722
    69 Anthos Investigative Site Wrocław DS Poland 51-162
    70 Anthos Investigative Site Żarów DS Poland 58-130
    71 Anthos Investigative Site Gdynia GDY Poland 81-423
    72 Anthos Investigative Site Zamość LB Poland 22-400
    73 Anthos Investigative Site Łódź LD Poland 92-213
    74 Anthos Investigative Site Lublin LU Poland 20-001
    75 Anthos Investigative Site Chrzanów MA Poland 32-500
    76 Anthos Investigative Site Kraków MA Poland 31-202
    77 Anthos Investigative Site Płock MZ Poland 09-402
    78 Anthos Investigative Site Warsaw MZ Poland 02-097
    79 Anthos Investigative Site Warszawa MZ Poland 04-628
    80 Anthos Investigative Site Przemyśl PK Poland 05-825
    81 Anthos Investigative Site Przemyśl PK Poland 37-700
    82 Anthos Investigative Site Gdynia PM Poland 81-157
    83 Anthos Investigative Site Bielsko-Biala SL Poland 43-316
    84 Anthos Investigative Site Dąbrowa Górnicza SL Poland 41-300
    85 Anthos Investigative Site Ruda Śląska SL Poland 41-710
    86 Anthos Investigative Site Tychy SL Poland 43-100
    87 Anthos Investigative Site Elbląg WN Poland 82-300
    88 Anthos Investigative Site Taipei HSZ Taiwan 30071
    89 Anthos Investigative Site Hualien City HUA Taiwan 970
    90 Anthos Investigative Site Yilan ILA Taiwan 26058
    91 Anthos Investigative Site Kaohsiung KHH Taiwan 807
    92 Anthos Investigative Site Taipei City TPE Taiwan 116
    93 Anthos Investigative Site Taipei TPE Taiwan 11217
    94 Anthos Investigative Site Tiachung TXG Taiwan 404

    Sponsors and Collaborators

    • Anthos Therapeutics, Inc.
    • The TIMI Study Group
    • Laboratory Corporation of America

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anthos Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT04755283
    Other Study ID Numbers:
    • ANT-006
    • 2020-004507-13
    First Posted:
    Feb 16, 2021
    Last Update Posted:
    May 20, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Anthos Therapeutics, Inc.
    randomized
    prospective
    blinded endpoint evaluation
    abelacimab
    MAA868
    rivaroxaban
    atrial fibrillation
    Factor XI
    stroke
    bleeding events
    anti-coagulant
    anticoagulation therapy
    Additional relevant MeSH terms:
    Atrial Fibrillation
    Rivaroxaban

    Study Results

    No Results Posted as of May 20, 2022