Clinical trial NCT04755283: Safety and Tolerability of Abelacimab (MAA868) vs. Rivaroxaban in Patients With Atrial Fibrillation
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Atrial Fibrillation (AF)
Stroke
Keywords: randomized
prospective
blinded endpoint evaluation
abelacimab
MAA868
rivaroxaban
atrial fibrillation
Factor XI
stroke
bleeding events
anti-coagulant
anticoagulation therapy
Lead sponsor: Anthos Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: The TIMI Study Group
name: Fortrea
First posted: 2021-02-16
Enrollment: 1287
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluate effect of abelacimab relative to rivaroxaban on the rate of major or clinically relevant non-major (CRNM) bleeding events
timeFrame: From randomization through study completion, an average of 17 months
Secondary outcomes:
measure: Evaluate effect of abelacimab relative to rivaroxaban on the rate of major bleeding events
timeFrame: From randomization through study completion, an average of 17 months
measure: Evaluate the effect of abelacimab relative to rivaroxaban on the rate of major or minor bleeding events
timeFrame: From randomization through study completion, an average of 17 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Anthos Investigative Site
state: Alabama
city: Mobile
country: United States
facility: Anthos Investigative Site
state: Alabama
city: Stamford
country: United States
facility: Anthos Investigative Site
state: Connecticut
city: Clearwater
country: United States
facility: Anthos Investigative Site
state: Florida
city: Daytona Beach
country: United States
facility: Anthos Investigative Site
state: Florida
city: Largo
country: United States
facility: Anthos Investigative Site
state: Florida
city: Safety Harbor
country: United States
facility: Anthos Investigative Site
state: Florida
city: Saint Augustine
country: United States
facility: Anthos Investigative Site
state: Florida
city: Johns Creek
country: United States
facility: Anthos Investigative Site
state: Georgia
city: Owensboro
country: United States
facility: Anthos Investigative Site
state: Kentucky
city: Baltimore
country: United States
facility: Anthos Investigative Site
state: Maryland
city: Salisbury
country: United States
facility: Anthos Investigative Site
state: Maryland
city: Framingham
country: United States
facility: Anthos Investigative Site
state: Massachusetts
city: Haverhill
country: United States
facility: Anthos Investigative Site
state: Massachusetts
city: Lansing
country: United States
facility: Anthos Investigative Site
state: Michigan
city: Sewell
country: United States
facility: Anthos Investigative Site
state: New Jersey
city: Poughkeepsie
country: United States
facility: Anthos Investigative Site
state: New York
city: Southampton
country: United States
facility: Anthos Investigative Site
state: New York
city: Lenoir
country: United States
facility: Anthos Investigative Site
state: North Carolina
city: Fargo
country: United States
facility: Anthos Investigative Site
state: North Dakota
city: Oklahoma City
country: United States
facility: Anthos Investigative Site
state: Oklahoma
city: Camp Hill
country: United States
facility: Anthos Investigative Site
state: Pennsylvania
city: Kingsport
country: United States
facility: Anthos Investigative Site
state: Tennessee
city: Kingwood
country: United States
facility: Anthos Investigative Site
state: Texas
city: Odessa
country: United States
facility: Anthos Investigative Site
state: Texas
city: Tomball
country: United States
facility: Anthos Investigative Site
state: Texas
city: Falls Church
country: United States
facility: Anthos Investigative Site
state: Virginia
city: Manassas
country: United States
facility: Anthos Investigative Site
state: Virginia
city: Cambridge
country: Canada
facility: Anthos Investigative Site
state: Ontario
city: Oshawa
country: Canada
facility: Anthos Investigative Site
state: Ontario
city: Sudbury
country: Canada
facility: Anthos Investigative Site
state: Ontario
city: Greenfield Park
country: Canada
facility: Anthos Investigative Site
state: Quebec
city: Montréal
country: Canada
facility: Anthos Investigative Site
state: Quebec
city: Mariánské Lázně
country: Czechia
facility: Anthos Investigative Site
state: KA
city: Trutnov
country: Czechia
facility: Anthos Investigative Site
state: KR
city: Liberec
country: Czechia
facility: Anthos Investigative Site
state: LB
city: Liberec
country: Czechia
facility: Anthos Investigative Site
state: LI
city: Česká Lípa
country: Czechia
facility: Anthos Investigative Site
state: LI
city: Pardubice
country: Czechia
facility: Anthos Investigative Site
state: PA
city: Praha
country: Czechia
facility: Anthos Investigative Site
state: PR
city: Praha
country: Czechia
facility: Anthos Investigative Site
state: PR
city: Praha
country: Czechia
facility: Anthos Investigative Site
state: PR
city: Brandýs Nad Labem
country: Czechia
facility: Anthos Investigative Site
state: Středočeský Kraj
city: Poděbrady
country: Czechia
facility: Anthos Investigative Site
state: Středočeský Kraj
city: Příbram
country: Czechia
facility: Anthos Investigative Site
state: Středočeský Kraj
city: Slaný
country: Czechia
facility: Anthos Investigative Site
state: Středočeský Kraj
city: Kroměříž
country: Czechia
facility: Anthos Investigative Site
state: ZL
city: Holešov
country: Czechia
facility: Anthos Investigative Site
state: Zlín
city: Orosháza
country: Hungary
facility: Anthos Investigative Site
state: BE
city: Baja
country: Hungary
facility: Anthos Investigative Site
state: BK
city: Budapest
country: Hungary
facility: Anthos Investigative Site
state: BP
city: Budapest
country: Hungary
facility: Anthos Investigative Site
state: BP
city: Budapest
country: Hungary
facility: Anthos Investigative Site
state: BU
city: Budapest
country: Hungary
facility: Anthos Investigative Site
state: BU
city: Székesfehérvár
country: Hungary
facility: Anthos Investigative Site
state: FE
city: Debrecen
country: Hungary
facility: Anthos Investigative Site
state: HB
city: Kaposvár
country: Hungary
facility: Anthos Investigative Site
state: SO
city: Nyíregyháza
country: Hungary
facility: Anthos Investigative Site (4002)
state: SZ
city: Nyíregyháza
country: Hungary
facility: Anthos Investigative Site (4003)
state: SZ
city: Balatonfüred
country: Hungary
facility: Anthos Investigative Site
state: VE
city: Balatonfüred
country: Hungary
facility: Anthos Investigative Site
state: VM
city: Seogu
country: Korea, Republic of
facility: Anthos Investigative Site
state: Busan
city: Seongnam-si
country: Korea, Republic of
facility: Anthos Investigative Site
state: Gyeonggi
city: Seongnam-si
country: Korea, Republic of
facility: Anthos Investigative Site
state: Gyeonggi
city: Seoul
country: Korea, Republic of
facility: Anthos Investigative Site
city: Seoul
country: Korea, Republic of
facility: Anthos Investigative Site
city: Seoul
country: Korea, Republic of
facility: Anthos Investigative Site
city: Wrocław
country: Poland
facility: Anthos Investigative Site
state: DS
city: Żarów
country: Poland
facility: Anthos Investigative Site
state: DS
city: Gdynia
country: Poland
facility: Anthos Investigative Site
state: GDY
city: Zamość
country: Poland
facility: Anthos Investigative Site
state: LB
city: Łódź
country: Poland
facility: Anthos Investigative Site
state: LD
city: Lublin
country: Poland
facility: Anthos Investigative Site
state: LU
city: Chrzanów
country: Poland
facility: Anthos Investigative Site
state: MA
city: Kraków
country: Poland
facility: Anthos Investigative Site
state: MA
city: Płock
country: Poland
facility: Anthos Investigative Site
state: MZ
city: Warsaw
country: Poland
facility: Anthos Investigative Site
state: MZ
city: Warszawa
country: Poland
facility: Anthos Investigative Site
state: MZ
city: Przemyśl
country: Poland
facility: Anthos Investigative Site
state: PK
city: Gdynia
country: Poland
facility: Anthos Investigative Site
state: PM
city: Bielsko-Biala
country: Poland
facility: Anthos Investigative Site
state: SL
city: Dąbrowa Górnicza
country: Poland
facility: Anthos Investigative Site
state: SL
city: Ruda Śląska
country: Poland
facility: Anthos Investigative Site
state: SL
city: Tychy
country: Poland
facility: Anthos Investigative Site
state: SL
city: Elbląg
country: Poland
facility: Anthos Investigative Site
state: WN
city: Taipei
country: Taiwan
facility: Anthos Investigative Site
state: HSZ
city: Hualien City
country: Taiwan
facility: Anthos Investigative Site
state: HUA
city: Yilan
country: Taiwan
facility: Anthos Investigative Site
state: ILA
city: Kaohsiung
country: Taiwan
facility: Anthos Investigative Site
state: KHH
city: Taipei City
country: Taiwan
facility: Anthos Investigative Site
state: TPE
city: Taipei
country: Taiwan
facility: Anthos Investigative Site
state: TPE
city: Tiachung
country: Taiwan
facility: Anthos Investigative Site
state: TXG
Study officials:
References:
citation: 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.