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

Sponsor
Anthos Therapeutics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04755283
Collaborator
The TIMI Study Group (Other), Covance (Industry)
1,200
Enrollment
118
Locations
2
Arms
26.9
Anticipated Duration (Months)
10.2
Patients Per Site
0.4
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 DiseaseIntervention/TreatmentPhase
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

ArmIntervention/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

    • 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

    SiteCityStateCountryPostal Code
    1Anthos Investigative SiteHuntsvilleAlabamaUnited States35801
    2Anthos Investigative SiteMobileAlabamaUnited States36608
    3Anthos Investigative SiteStamfordConnecticutUnited States06905
    4Anthos Investigative SiteClearwaterFloridaUnited States33756
    5Anthos Investigative SiteDaytona BeachFloridaUnited States32114-2321
    6Anthos Investigative SiteLargoFloridaUnited States33777
    7Anthos Investigative SiteSafety HarborFloridaUnited States34695
    8Anthos Investigative SiteSaint AugustineFloridaUnited States32086
    9Anthos Investigative SiteJohns CreekGeorgiaUnited States30024
    10Anthos Investigative SiteOwensboroKentuckyUnited States42303
    11Anthos Investigative SiteBaltimoreMarylandUnited States21229-5222
    12Anthos Investigative SiteSalisburyMarylandUnited States21804
    13Anthos Investigative SiteFraminghamMassachusettsUnited States01701
    14Anthos Investigative SiteHaverhillMassachusettsUnited States01830
    15Anthos Investigative SiteLansingMichiganUnited States48912
    16Anthos Investigative SiteDoverNew HampshireUnited States03820
    17Anthos Investigative SiteSewellNew JerseyUnited States08080
    18Anthos Investigative SitePoughkeepsieNew YorkUnited States12601
    19Anthos Investigative SiteSouthamptonNew YorkUnited States11968
    20Anthos Investigative SiteLenoirNorth CarolinaUnited States28645
    21Anthos Investigative SiteFargoNorth DakotaUnited States58104
    22Anthos Investigative SiteOklahoma CityOklahomaUnited States73135
    23Anthos Investigative SiteCamp HillPennsylvaniaUnited States17011
    24Anthos Investigative SiteKingsportTennesseeUnited States37660
    25Anthos Investigative SiteKingwoodTexasUnited States77339
    26Anthos Investigative SiteOdessaTexasUnited States79761-5133
    27Anthos Investigative SiteTomballTexasUnited States77375
    28Anthos Investigative SiteFalls ChurchVirginiaUnited States22042
    29Anthos Investigative SiteManassasVirginiaUnited States20109
    30Anthos Investigative SiteNew WestminsterBritish ColumbiaCanadaV3L 3W5
    31Anthos Investigative SiteCambridgeOntarioCanadaN1R 7R1
    32Anthos Investigative SiteNewmarketOntarioCanadaL3Y 5G8
    33Anthos Investigative SiteOshawaOntarioCanadaL1J2K1
    34Anthos Investigative SiteSudburyOntarioCanadaP3B 4H5
    35Anthos Investigative SiteGreenfield ParkQuebecCanadaJ4V 2G8
    36Anthos Investigative SiteMontréalQuebecCanadaH1T 3Y7
    37Anthos Investigative SiteMariánské LázněKACzechia353 01
    38Anthos Investigative SiteTrutnovKRCzechia541 01
    39Anthos Investigative SiteLiberecLBCzechia460 01
    40Anthos Investigative SiteLiberecLICzechia460 01
    41Anthos Investigative SiteČeská LípaLICzechia470 01
    42Anthos Investigative SitePardubicePACzechia530 02
    43Anthos Investigative SitePrahaPRCzechia10100
    44Anthos Investigative SitePrahaPRCzechia110 00
    45Anthos Investigative SitePrahaPRCzechia158 00
    46Anthos Investigative SiteBenešovStředočeský KrajCzechia256 01
    47Anthos Investigative SiteBrandýs Nad LabemStředočeský KrajCzechia250 01
    48Anthos Investigative SitePoděbradyStředočeský KrajCzechia29001
    49Anthos Investigative SitePříbramStředočeský KrajCzechia261 01
    50Anthos Investigative SiteSlanýStředočeský KrajCzechia274 01
    51Anthos Investigative SiteKroměřížZLCzechia767 01
    52Anthos Investigative SiteHolešovZlínCzechia769 01
    53Anthos Investigative SiteOrosházaBEHungary5900
    54Anthos Investigative SiteBajaBKHungary6500
    55Anthos Investigative SiteBudapestBPHungary1036
    56Anthos Investigative SiteBudapestBPHungary1122
    57Anthos Investigative SiteBudapestBUHungary1033
    58Anthos Investigative SiteBudapestBUHungary1085
    59Anthos Investigative SiteBudapestBUHungary1134
    60Anthos Investigative SiteBudapestBUHungary1145
    61Anthos Investigative SiteMiskolcBZHungary3526
    62Anthos Investigative SiteSzékesfehérvárFEHungary8000
    63Anthos Investigative SiteDebrecenHBHungary4025
    64Anthos Investigative SiteGyöngyösHEHungary3200
    65Anthos Investigative SiteSzegedSDHungary6725
    66Anthos Investigative SiteKaposvárSOHungary7400
    67Anthos Investigative Site (4002)NyíregyházaSZHungary4400
    68Anthos Investigative Site (4003)NyíregyházaSZHungary4400
    69Anthos Investigative SiteBalatonfüredVEHungary8230
    70Anthos Investigative SiteBalatonfüredVMHungary8230
    71Anthos Investigative SiteSeoguBusanKorea, Republic of49201
    72Anthos Investigative SiteSeongnam-siGyeonggiKorea, Republic of13496
    73Anthos Investigative SiteSeongnam-siGyeonggiKorea, Republic of13620
    74Anthos Investigative SiteDaeguKorea, Republic of41931
    75Anthos Investigative SiteDaeguKorea, Republic of705-718
    76Anthos Investigative SiteGwangjuKorea, Republic of61469
    77Anthos Investigative SiteSeoulKorea, Republic of158-710
    78Anthos Investigative SiteSeoulKorea, Republic of2447
    79Anthos Investigative SiteSeoulKorea, Republic of3080
    80Anthos Investigative SiteSeoulKorea, Republic of3722
    81Anthos Investigative SiteSeoulKorea, Republic of7061
    82Anthos Investigative SiteŁódźALPoland90-442
    83Anthos Investigative SiteWrocławDSPoland51-124
    84Anthos Investigative SiteWrocławDSPoland51-162
    85Anthos Investigative SiteŻarówDSPoland58-130
    86Anthos Investigative SiteGdyniaGDYPoland81-423
    87Anthos Investigative SiteZamośćLBPoland22-400
    88Anthos Investigative SiteŁódźLDPoland91-002
    89Anthos Investigative SiteŁódźLDPoland92-213
    90Anthos Investigative SiteLublinLUPoland20-001
    91Anthos Investigative SiteChrzanówMAPoland32-500
    92Anthos Investigative SiteKrakówMAPoland30-688
    93Anthos Investigative SiteKrakówMAPoland31-202
    94Anthos Investigative SitePłockMZPoland09-402
    95Anthos Investigative SiteWarsawMZPoland02-097
    96Anthos Investigative SiteWarszawaMZPoland04-628
    97Anthos Investigative SitePrzemyślPKPoland05-825
    98Anthos Investigative SitePrzemyślPKPoland37-700
    99Anthos Investigative SiteGdyniaPMPoland81-157
    100Anthos Investigative SiteBielsko-BialaSLPoland43-316
    101Anthos Investigative SiteDąbrowa GórniczaSLPoland41-300
    102Anthos Investigative SiteRuda ŚląskaSLPoland41-710
    103Anthos Investigative SiteTychySLPoland43-100
    104Anthos Investigative SiteElblągWNPoland82-300
    105Anthos Investigative SiteChanghuaCHATaiwan500
    106Anthos Investigative SiteTaipeiHSZTaiwan30071
    107Anthos Investigative SiteHualien CityHUATaiwan970
    108Anthos Investigative SiteYilanILATaiwan26058
    109Anthos Investigative SiteKaohsiungKHHTaiwan807
    110Anthos Investigative SiteKaohsiungKHHTaiwan813
    111Anthos Investigative SiteTainanTNNTaiwan704
    112Anthos Investigative SiteTainanTNNTaiwan710
    113Anthos Investigative SiteTaipei CityTPETaiwan10630
    114Anthos Investigative SiteTaipei CityTPETaiwan116
    115Anthos Investigative SiteTaipeiTPETaiwan11217
    116Anthos Investigative SiteTaipeiTPETaiwan11490
    117Anthos Investigative SiteTaichungTXGTaiwan407
    118Anthos Investigative SiteTiachungTXGTaiwan404

    Sponsors and Collaborators

    • Anthos Therapeutics, Inc.
    • The TIMI Study Group
    • Covance

    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:
    Nov 16, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Anthos Therapeutics, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 16, 2021