A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE (ASTER)

A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Phase 3 Study Comparing the Effect of Abelacimab Relative to Apixaban on Venous Thromboembolism (VTE) Recurrence and Bleeding in Patients With Cancer Associated VTE

This is a Phase 3,multicenter, randomized, open-label, blinded endpoint evaluation study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer associated VTE (ASTER)

Study Overview

• Status: Terminated
• Conditions: Venous Thromboembolism; Pulmonary Embolism; Deep Venous Thrombosis
• Intervention / Treatment: Biological: Abelacimab; Drug: Apixaban

Detailed Description

Cancer associated thrombosis (CAT) is a severe medical condition which is characterized by high incidence of Venous thromboembolism (VTE) recurrence and high risk for bleeding. The two most common treatments today are low molecular weight heparin (LMWH) and direct anticoagulants (DOACs), in which each has limitations. DOACs are administered orally and are seen as a more convenient alternative though associated with bleeding risk; further, some cancer patients have difficulty swallowing or develop vomiting which leads to unpredictable pharmacodynamic effects with oral therapy. The ANT-007 study will compare treatment with abelacimab monthly administration to apixaban twice daily administration over a 6-month treatment. The study outcomes include VTE recurrence, bleeding event and treatment discontinuation at 6 months

• Study Type: Interventional
• Enrollment (Actual): 1150
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Perth, Australia, 6005
    • Perth Blood Institute
  • Prahran, Australia, 3181
    • The Alfred Hospital
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Blacktown Hospital
    • Concord, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Box Hill Hospital
    • Clayton, Victoria, Australia, 3168
      • Monash Medical Centre Clayton
    • Epping, Victoria, Australia, 3076
      • Northern Health
• Austria
  • Graz, Austria, 8010
    • LKH - Universitätsklinikum Graz
  • Neustadt, Austria, 2700
    • LK Wiener Neustadt
  • Vienna, Austria, 1090
    • Medical University of Vienna
• Canada
  • Nova Scotia, Canada, B3H 2Y9
    • Queen Elizabeth II Health Sciences Centre
  • Québec, Canada, H4A 3J1
    • McGill University Health Centre
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • University of Calgary
    • Edmonton, Alberta, Canada, T6G2V2
      • University of Alberta Hospital
  • Ontario
    • Hamilton, Ontario, Canada, L8V 1C3
      • Hamilton Health Sciences, Juravinski Hospital and Cancer Centre
    • Ottawa, Ontario, Canada, K1H BL6
      • Ottawa Hospital
    • Saint Catharines, Ontario, Canada, L2S 0A9
      • Niagara Health System
    • Sault Ste. Marie, Ontario, Canada, P6A 0A8
      • Sault Area Hospital
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre
    • Montreal, Quebec, Canada, H3T-1E2
      • Jewish General Hospital
• China
  • Beijing, China, 100191
    • Peking University Third Hospital
  • Beijing, China, 100038
    • Beijing Shijitan Hosp.
  • Ch’ang-ch’un, China, 130012
    • Jilin Province Tumor Hospital
  • Guangdong, China, 510280
    • Southern Medical University - Zhujiang Hospital
  • Guangzhou, China, 510655
    • The Sixth Affiliated Hospital of Sun Yat-sen University
  • Guangzhou, China, 510515
    • Nanfang Hospital of Southern Medical University
  • Huizhou, China, 516001
    • Huizhou Municipal Central Hospital
  • Nanjing, China, 210029
    • Jiangsu Province Hospital
  • Nanjing, China, 210006
    • Nanjing First Hospital
  • Wenzhou, China, 325000
    • The First Affiliated Hospital of Wenzhou Medical University
  • Wuhan, China, 430023
    • Union Hospital Tongji Medical College Huazhong University of Science &Technology
  • Wuhan, China, 430030
    • Tongji Hospital, Tongji Medical College
  • Xi'an, China, 710061
    • 1st Affiliate Hospital of Xi'an Jiao
• Czechia
  • Brno, Czechia, 65653
    • Masarykuv onkologicky ustav
  • Hradec Králové, Czechia, 50005
    • University hospital Hradec Králové
  • Nová Ves pod Pleší, Czechia, 26204
    • Nemocnice Na Pleši s.r.o.
  • Prague, Czechia, 14059
    • Thomayerova nemocnice
  • Prague, Czechia, 128 08
    • Onkologická klinika VFN a 1. LF UK
• France
  • Amiens, France, 80057
    • CHU Amiens - Hopital Nord
  • Angers, France, 49933
    • CHU Angers - Hopital Hotel Dieu
  • Brest, France, 29609
    • Chu de Brest - Hopital de La Cavale Blanche
  • Clermont-Ferrand, France, 63003
    • CHU Clermont Ferrand - Hopital Gabriel Montpied
  • Colombes, France, 92700
    • Hopital Louis Mourier
  • Dijon, France, 21079
    • CHU Dijon - Hôpital Bocage Central
  • Grenoble, France, 38043
    • CHU de Grenoble - Hôpital Albert Michallon
  • Le Puy-en-Velay, France, 43000
    • CH Le puy en Velay
  • Limoges, France, 87042
    • CHU de Limoges - Hopital Dupuytren
  • Marseille, France, 13385
    • Hopital Timone Adultes
  • Morlaix, France, 29600
    • Centre Hospitalier Des Pays De Morlaix
  • Paris, France, 75015
    • Hôpital Européen Georges Pompidou
  • Paris, France, 75651
    • Groupe Hospitalier Pitie-Salpetriere
  • Pierre-Bénite, France, 69310
    • Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
  • Rouen, France, 76031
    • CHU de Rouen - Hôpital de Bois Guillaume
  • Saint-Etienne, France, 42000
    • CHU de Saint-Étienne - Hôpital Nord
  • Strasbourg, France, 67091
    • Nouvel Hôpital Civil de Strasbourg
  • Strasbourg, France, 67091
    • CHU Strasbourg - Nouvel Hopital Civil
  • Toulon, France, 83000
    • Centre Hospitalier Intercommunal de Toulon
  • Toulouse, France, 31059
    • CHU de Toulouse - Hopital Rangueil
  • Vandœuvre-lès-Nancy, France, 54500
    • CHU de Nancy - Hôpital de Brabois Adultes
  • Vandœuvre-lès-Nancy, France, 54511
    • CHU de Nancy - Hôpital de Brabois Adultes
• Germany
  • Dresden, Germany, 1307
    • Universitaetsklinikum Carl Gustav Carus TU Dresden
  • Dresden, Germany, 1067
    • Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt
  • Görlitz, Germany, 2827
    • Praxis für Gefäßmedizin
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg-Eppendorf
  • Kiel, Germany, 24105
    • Universitätsklinik der Christian-Albrechts-Universität
  • Leipzig, Germany, 4103
    • Universitätsklinik Leipzig
  • Magdeburg, Germany, 39120
    • Universitaetsklinikum Magdeburg A.oe.R
  • München, Germany, 80336
    • Klinikum der Universitaet Muenchen
• Hungary
  • Debrecen, Hungary, H-4032
    • Debreceni Egyetem
  • Eger, Hungary, H-3300
    • Markhot Ferenc Oktatokorhaz és Rendelointezet
  • Kecskemét, Hungary, 6000
    • Bacs-Kiskun County Hospital
• Ireland
  • Cork, Ireland
    • Cork University Hospital
  • Cork, Ireland
    • Bon Secour Hospital
  • Dublin, Ireland, V2N0
    • Beaumont Hospital
  • Dublin, Ireland
    • Msdyrt Midericordiae University Hospital
  • Limerick, Ireland, V94 T9PX
    • University Hospital, Limerick
• Italy
  • Bari, Italy, 70124
    • IRCCS Istituto Tumori Giovanni Paolo II
  • Bergamo, Italy, 24127
    • Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
  • Bologna, Italy, 40133
    • Arcispedale S. Maria Nuova Azienda Ospedaliera Di Reggio Emilia
  • Castelfranco Veneto, Italy, 31033
    • Presidio Ospedaliero di Castelfranco Veneto
  • Chieti, Italy, 66100
    • SS. ma Annunziata
  • Cosenza, Italy, 87100
    • Ospedale Civile Dell Annunziata
  • Faenza, Italy, 48018
    • Ospedale degli Infermi
  • Genova, Italy, 16132
    • Azienda Ospedaliero Universitaria San Martino
  • Milan, Italy, 20142
    • Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo
  • Modena, Italy, 41124
    • A.O.U. Policlinico di Modena
  • Napoli, Italy, 80131
    • Istituto Nazionale Tumori Fondazione G. Pascale
  • Padua, Italy, 35128
    • Azienda Ospedale - Università Padova
  • Parma, Italy, 43100
    • Azienda Ospedaliero Universitaria di Parma
  • Perugia, Italy, 6132
    • Universit degli Studi di Perugia - Azienda Ospedaliera di Perugia
  • Pisa, Italy, 56126
    • Azienda Ospedaliero Universitaria Pisana
  • Reggio Emilia, Italy, 42123
    • Arcispedale S. Maria Nuova Azienda Ospedaliera Di Reggio Emilia
  • Roma, Italy, 168
    • Fondazione Policlinico Universitario A. Gemelli IRCCS.
  • Rozzano, Italy, 20089
    • Istituto Clinico Humanitas
  • Treviso, Italy, 35128
    • Ospedale Santa Maria di Cà Foncello
  • Udine, Italy, 33100
    • Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
  • Varese, Italy, 21100
    • Università dell'Insubria
  • Venezia, Italy, 30122
    • Ospedale SS. Giovanni e Paolo
  • Verduno, Italy, 12060
    • Ospedalemichele e Pietro ferrer
  • Vicenza, Italy, 36100
    • Ospedale San Bortolo di Vicenza
• Japan
  • Chiba, Japan, 275-0006
    • Chibaken Saiseikai Narashino Hospital
  • Fukuoka, Japan, 812-8582
    • Kyushu University Hospital
  • Isehara, Japan, 259-1193
    • Tokai University Hospital
  • Kanagawa, Japan, 236-0037
    • Yokohama Minami Kyosai Hospital
  • Kobe, Japan, 650-0017
    • Kobe University Hospital
  • Kumamoto, Japan, 860-8556
    • Kumamoto University Hospital
  • Kyoto, Japan, 606-8507
    • Kyoto University Hospital
  • Mie, Japan, 514-8507
    • Mie University Hospital
  • Minatoku, Japan, 108-0073
    • Tokyo Saiseikai Central Hospital
  • Miyagi, Japan, 980-8574
    • Tohoku University Graduate School of Medicine
  • Okayama, Japan, 7011192
    • Okayama Medical Center
  • Osaka, Japan, 541-8567
    • Osaka International Cancer Institute
  • Tokyo, Japan, 181-8611
    • Kyorin University Hospital
  • Tokyo, Japan, 113-8421
    • Juntendo University Hospital
  • Tokyo, Japan, 108-8329
    • International University of Health and Welfare MITA Hospital
  • Tokyo
    • Tsukiji, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital
• Latvia
  • Daugavpils, Latvia, LV-5417
    • Daugavpils Regional Hospital
  • Liepāja, Latvia, LV3414
    • Liepaja Regional Hospital
  • Riga, Latvia, LV-1002
    • Pauls Stradins Clinical University Hospital
• Netherlands
  • Amersfoort, Netherlands, 1066 EC
    • Meander Medisch Centrum
  • Amersfoort, Netherlands, 3813
    • Meander Medisch Centrum
  • Amsterdam, Netherlands, 1091 AC
    • Onze Lieve Vrouwe Gasthuis, locatie Oost
  • Amsterdam, Netherlands, 1091
    • Onze Lieve Vrouwe Gasthuis, locatie Oost
  • Beverwijk, Netherlands, 1942
    • Rode Kruis Ziekenhuis
  • Dordrecht, Netherlands, 3317
    • Albert Schweitzer Ziekenhuis, Dordwijk
  • Groningen, Netherlands, 9713
    • Universitair Medisch Centrum Groningen
  • Hilversum, Netherlands, 1213
    • Tergooiziekenhuizen, Hilversum
  • Holland, Netherlands, 1105AZ
    • Amsterdam University Medical Center
  • Hoofddorp, Netherlands, 2134TM
    • Spaarne Gasthuis (Kennemer Gasthuis) - Haarlem-Zuid
  • Leiden, Netherlands, 2333 ZA
    • Leids Universitair Medisch Centrum
  • Nijmegen, Netherlands, 6525
    • Radboud Universitair Medisch Centrum
  • Rotterdam, Netherlands, 3083 AN
    • Ikazia Ziekenhuis
  • The Hague, Netherlands, 2545 AA
    • Haga Ziekenhuis
• Norway
  • Fredrikstad, Norway, 1603
    • Østfold Hospital Kalnes
  • Lørenskog, Norway, 1478
    • Akershus Univeristy Hospital
• South Korea
  • Anyang, South Korea, 14068
    • Hallym University Sacred Heart Hospital
  • Bucheon-si, South Korea, 14584
    • Soonchunhyang University Hospital Bucheon
  • Daegu, South Korea, 42472
    • Daegu Catholic University Medical Center
  • Jeonju, South Korea, 54907
    • Jeonbuk National University Hospital
  • Seogu, South Korea, 49201
    • Dong-A University Hospital
  • Seoul, South Korea, 4401
    • Soonchunhyang University Seoul Hospital
  • Yangcheon, South Korea, 07985
    • Ewha Womans University Mokdong Hospital
  • Yŏngsan, South Korea, 04401
    • Soonchunhyang University Seoul Hospital
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, South Korea, 10475
      • Myongji Hospital
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Seoul National University Bundang Hospital
    • Yongin-si, Gyeonggi-do, South Korea, 16995
      • Yongin Severance Hospital, Yonsei University Health System
• Spain
  • Barcelona, Spain, 8036
    • Hospital Clínic de Barcelona
  • Barcelona, Spain, 8041
    • Hospital de la Santa Creu i Sant Pau
  • Elche, Spain, 3203
    • Hospital General Universitario de Elche
  • Elche, Spain, 03001
    • Hospital Universitario del Vinalopó
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de Las Nieves
  • Jaén, Spain, 23007
    • Hospital Universitario Ciudad de Jaen
  • Lugo, Spain, 27003
    • Hospital Universitario Lucus Augusti
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon
  • Madrid, Spain, 28040
    • Hospital Universitario Clinico San Carlos
  • Madrid, Spain, 28027
    • Clinica Universidad de Navarra
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor
  • Madrid, Spain, 28033
    • MD Anderson Cancer Centre
  • Majadahonda, Spain, 28220
    • Hospital Universitario Puerta de Hierro Majadahonda
  • Ourense, Spain, 32005
    • Complejo Hospitalario Universitario de Orense
  • Pamplona, Spain, 31008
    • Clinica Universidad de Navarra
  • Sabadell, Spain, 8208
    • Corporacio Sanitaria Parc Tauli
  • Santander, Spain, 39012
    • Hospital Universitario Marques de Valdecilla
  • Santiago de Compostela, Spain, 15706
    • Complejo Hospitalario Universitario de Santiago
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocío
• Sweden
  • Sundsvall, Sweden, 85186
    • Länssjukhuset Sundsvall-Härnösand
• Switzerland
  • Geneva, Switzerland, 1205
    • Hopital Universitaire Geneve
  • Lausanne, Switzerland, 1011
    • Centre hospitalier universitaire vaudois
  • Zurich, Switzerland, 8091
    • University of Zurich
• Taiwan
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • New Taipei City, Taiwan, 220
    • Far Eastern Memorial Hospital
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Tainan, Taiwan, 70403
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 114
    • Tri-Service General Hospital
  • Taipei, Taiwan, 112
    • Koo Foundation Sun Yat-Sen Cancer Center
• United Kingdom
  • ENG
    • Cottingham, ENG, United Kingdom, HU16 5JQ
      • Castle Hill Hospital, Department of Oncology & Haematology
    • London, ENG, United Kingdom, E1 188
      • Barts Health NHS Trust
    • Newcastle upon Tyne, ENG, United Kingdom, NE7 7DN
      • The Newcastle Upon Tyne Hospitals
  • England
    • Cardiff, England, United Kingdom, CF14 4XW
      • University Hospital of Wales
    • Stafford, England, United Kingdom, ST16 3SA
      • University Hospitals of North Midlands
    • Stoke-on-Trent, England, United Kingdom, ST4 6QG
      • University Hospitals of North Midlands
  • SCO
    • Glasgow, SCO, United Kingdom, G514TF
      • Queen Elizabeth University Hospital Campus
• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus
  • Connecticut
    • West Haven, Connecticut, United States, 06516-5907
      • VA Connecticut Healthcare System
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20422
      • Washington DC VAMC
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Health
  • Illinois
    • Evanston, Illinois, United States, 60201
      • NorthShore University Health System
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0093
      • University of Kentucky, Markey Cancer Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02215-5400
      • Beth Israel Deaconess Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University
  • New Jersey
    • Middletown, New Jersey, United States, 07748
      • Memorial Sloan Kettering Cancer Center-Middletown
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Cancer Center-Commack
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Cancer Center-West Harrison
    • New York, New York, United States, 10021-0005
      • Memorial Sloan Kettering Cancer Center
    • Rochester, New York, United States, 14621
      • Lipson Cancer Institute
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania - Penn Blood Disorders Center
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
    • San Antonio, Texas, United States, 78229
      • University of Texas Mays Cancer Center
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Health System
    • Milwaukee, Wisconsin, United States, 53226
      • Blood Center of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female subjects ≥18 years old or other legal maturity age according to the country of residence

• Confirmed diagnosis of cancer (by histology, adequate imaging modality), other than basal-cell or squamous-cell carcinoma of the skin alone with one of the following:

  • Active cancer, defined as either locally active, regionally invasive, or metastatic cancer at the time of randomization and/or
  • Currently receiving or having received anticancer therapy (radiotherapy, chemotherapy, hormonal therapy, any kind of targeted therapy or any other anticancer therapy) in the last 6 months.
• Confirmed symptomatic or incidental proximal lower limb deep vein thrombosis (DVT) (i.e., popliteal, femoral, iliac, and/or inferior vena cava [IVC] thrombosis) and/or a confirmed symptomatic pulmonary embolism (PE), or an incidental PE in a segmental, or larger pulmonary artery.

Patients are eligible within 120 hours from diagnosis of the qualifying VTE

• Anticoagulation therapy with a therapeutic dose of DOAC for at least 6 months is indicated
• Able to provide written informed consent

Exclusion Criteria:

• Thrombectomy, insertion of a caval filter or use of a fibrinolytic agent to treat the current (index) DVT and/or PE
• More than 120 hours of pre-treatment with therapeutic doses of UFH, LMWH, fondaparinux, DOAC, or other anticoagulants
• An indication to continue treatment with therapeutic doses of an anticoagulant other than that VTE treatment prior to randomization (e.g., atrial fibrillation [AF], mechanical heart valve, prior VTE)
• Platelet count <50,000/mm3 at the screening visit
• PE leading to hemodynamic instability (blood pressure [BP] <90 mmHg or shock)
• Acute ischemic or hemorrhagic stroke or intracranial hemorrhage within the 4 weeks preceding screening
• Brain trauma or a cerebral or spinal cord surgery or spinal procedures such as lumbar puncture or epidural/spinal anesthesia within 4 weeks of screening
• Need for aspirin in a dosage of >100 mg/day or any other antiplatelet agent alone or in combination with aspirin
• Primary brain cancer or untreated intracranial metastases at baseline
• Acute myeloid or lymphoid leukemia
• Bleeding requiring medical attention at the time of randomization or in the preceding 4 weeks
• Planned brain, spinal cord, cardiac, vascular, major thoracic and/or major abdominal surgery in the 4 weeks following randomization
• Eastern Cooperative Oncology Group (ECOG) performance status of 3 or 4 at screening
• Life expectancy <3 months at randomization
• Calculated creatinine clearance (CrCl) <30 mL/min (Cockcroft-Gault equation) at the screening visit
• Hemoglobin <8 g/dL at the screening visit
• Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase (ALT) ≥3 x and/or bilirubin ≥2 x upper limit of normal (ULN) at the screening visit in absence of clinical explanation
• Uncontrolled hypertension (systolic BP>180 mm Hg or diastolic BP >100 mm Hg despite antihypertensive treatment)
• Women of child-bearing potential (WOCBP) who are unwilling or unable to use highly effective contraceptive measures during the study from screening up to 3 days after last treatment of apixaban or 100 days after administration of abelacimab (See Section 5.3.6. for highly effective contraceptive measures)
• Sexually active males with sexual partners of childbearing potential must agree to use a condom or other reliable contraceptive measure up to 3 days after last treatment of apixaban or 100 days after administration of abelacimab
• Pregnant or breast-feeding women
• Patients known to be receiving strong dual inducers or inhibitors of both CYP3A4 and P gp
• History of hypersensitivity to any of the study drugs (including apixaban) or excipients, to drugs of similar chemical classes, or any contraindication listed in the label for apixaban
• Subjects with any condition that in the Investigator's judgement would place the subject at increased risk of harm if he/she participated in the study
• Use of other investigational (not registered) drugs within 5 half-lives prior to enrollment or until the expected pharmacodynamic(s) (PD) effect has returned to baseline, whichever is longer. Participation in academic non-interventional studies or interventional studies, comprising testing different strategies or different combinations of registered drugs is permitted

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abelacimab; Abelacimab intravenous administration followed by monthly administration of the same dose subcutaneously	Biological: Abelacimab; Abelacimab 150 mg; Other Names: MAA868
Active Comparator: Apixaban; Apixaban administered orally twice a day	Drug: Apixaban; Apixaban 10 mg followed by 5 mg; Other Names: Eliquis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first event of centrally adjudicated VTE recurrence	Time to first event of centrally adjudicated venous thromboembolism (VTE) recurrence	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first event of ISTH-adjudicated major bleeding events	Time to first adjudicated major bleeding event	Up to 6 months
Time to first event of ISTH-adjudicated major or clinically relevant non-major (CRNM) bleeding events	Time to first adjudicated major or clinically relevant non-major (CRNM) bleeding event	Up to 6 months
Time to first event of VTE recurrence, ISTH adjudicated major or ISTH-adjudicated clinically relevant non-major (CRNM) bleeding events	Time to first adjudicated venous thromboembolism (VTE) or bleeding event	Up to 6 months
Time to event of permanent treatment discontinuation not due to death	Time to permanent discontinuation not due to death	Up to 6 months
Time to first event of ISTH-adjudicated clinically relevant non-major (CRNM) bleeding events	Time to first adjudicated clinically relevant non-major (CRNM) bleeding event	Up to 6 months
Time to first event of GI ISTH-adjudicated major and CRNM bleeding events	Time to first adjudicated gastrointestinal (GI) major and clinically relevant non-major (CRNM) bleeding event	Up to 6 months
All-cause death, vascular death, serious adverse events, adverse events leading to drug discontinuation, other adverse events, abnormal lab tests, etc. presented as rate per 100 patient-years		Up to 6 months
For patients treated with abelacimab: percent with injection site reactions/severity, hypersensitivity reactions/severity, anti-drug antibody formation, neutralizing antibody		Up to 6 months

Collaborators and Investigators

• Sponsor: Anthos Therapeutics, Inc.
• Collaborators: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2022
• Primary Completion (Actual): February 4, 2026
• Study Completion (Actual): February 4, 2026

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: December 23, 2021
• First Posted (Actual): December 28, 2021

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Apixaban; Anticoagulants; LMWH; CAT; VTE recurrence rate; PROBE design; Cancer associated VTE; Abelacimab; FXI; Major bleeding events; CRNM bleeding events
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Thromboembolism; Thrombosis; Pulmonary Embolism; Venous Thrombosis; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Anticoagulants; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; apixaban; abelacimab; MAA868
• Other Study ID Numbers: ANT-007; 2023-509569-19-00 (Other Identifier: EUCT number); CMAA868D12302 (Other Identifier: Novartis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No