AzTrials
AzTrials

Venous ThromboembolismPhase 3ASTERNCT05171049

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

A Phase 3 study testing Abelacimab and Apixaban in people with Venous Thromboembolism and Deep Venous Thrombosis, run by Anthos Therapeutics, Inc. at 209 sites in 21 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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) Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Abelacimab and Apixaban
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,150 participants
Where
209 sitesin 21 countries
Study dates
5 May 2022to 4 Feb 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 25Show fewer
  • 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

Trial locations and contacts

209 sites in 21 countries.

209 sites in 21 countries

Italy24 sites

  • IRCCS Istituto Tumori Giovanni Paolo II

    Bari, 70124

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    Bergamo, 24127

  • Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia

    Bologna, 40133

  • Presidio Ospedaliero di Castelfranco Veneto

    Castelfranco Veneto, 31033

  • SS. ma Annunziata

    Chieti, 66100

  • Ospedale Civile Dell Annunziata

    Cosenza, 87100

  • Ospedale Degli Infermi

    Faenza, 48018

  • Azienda Ospedaliero Universitaria San Martino

    Genova, 16132

  • Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo

    Milan, 20142

  • A.O.U. Policlinico di Modena

    Modena, 41124

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, 80131

  • Azienda Ospedale - Università Padova

    Padova, 35128

  • Azienda Ospedaliero Universitaria di Parma

    Parma, 43100

  • Universit degli Studi di Perugia - Azienda Ospedaliera di Perugia

    Perugia, 6132

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

  • Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia

    Reggio Emilia, 42123

  • Fondazione Policlinico Universitario A. Gemelli IRCCS.

    Roma, 168

  • Istituto Clinico Humanitas

    Rozzano, 20089

  • Ospedale Santa Maria di Cà Foncello

    Treviso, 35128

  • Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

    Udine, 33100

  • Università dell'Insubria

    Varese, 21100

  • Ospedale SS. Giovanni e Paolo

    Venezia, 30122

  • Ospedalemichele e Pietro ferrer

    Verduno, 12060

  • Ospedale San Bortolo di Vicenza

    Vicenza, 36100

Other trials in Italy

United States23 sites

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215-5400

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Memorial Sloan Kettering Cancer Center-Commack

    Commack, New York, 11725

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • NorthShore University Health System

    Evanston, Illinois, 60201

  • Memorial Sloan Kettering Cancer Center-West Harrison

    Harrison, New York, 10604

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Gundersen Health System

    La Crosse, Wisconsin, 54601

  • University of Kentucky, Markey Cancer Center

    Lexington, Kentucky, 40536-0093

  • University of Miami Health

    Miami, Florida, 33136

  • Memorial Sloan Kettering Cancer Center-Middletown

    Middletown, New Jersey, 07748

  • Blood Center of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021-0005

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • University of Pennsylvania - Penn Blood Disorders Center

    Philadelphia, Pennsylvania, 19104

  • Lipson Cancer Institute

    Rochester, New York, 14621

  • University of Texas Mays Cancer Center

    San Antonio, Texas, 78229

  • Washington University

    St Louis, Missouri, 63110

  • Washington DC VAMC

    Washington D.C., District of Columbia, 20422

  • VA Connecticut Healthcare System

    West Haven, Connecticut, 06516-5907

Other trials in United States

France22 sites

  • CHU Amiens - Hopital Nord

    Amiens, 80057

  • CHU Angers - Hôpital Hôtel Dieu

    Angers, 49933

  • CHU de Brest - Hôpital de la Cavale Blanche

    Brest, 29609

  • CHU Clermont Ferrand - Hopital Gabriel Montpied

    Clermont-Ferrand, 63003

  • Hôpital Louis Mourier

    Colombes, 92700

  • CHU Dijon - Hôpital Bocage Central

    Dijon, 21079

  • CHU de Grenoble - Hôpital Albert Michallon

    Grenoble, 38043

  • CH Le Puy en Velay

    Le Puy-en-Velay, 43000

  • CHU de Limoges - Hôpital Dupuytren

    Limoges, 87042

  • Hopital Timone Adultes

    Marseille, 13385

  • Centre hospitalier des pays de Morlaix

    Morlaix, 29600

  • Hôpital Européen Georges Pompidou

    Paris, 75015

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, 75651

  • Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud

    Pierre-Bénite, 69310

  • CHU de Rouen - Hôpital de Bois Guillaume

    Rouen, 76031

  • CHU de Saint-Etienne - Hopital Nord

    Saint-Etienne, 42000

  • CHU Strasbourg - Nouvel Hôpital Civil

    Strasbourg, 67091

  • Nouvel Hôpital Civil de Strasbourg

    Strasbourg, 67091

  • Centre Hospitalier Intercommunal de Toulon

    Toulon, 83000

  • CHU de Toulouse - Hôpital Rangueil

    Toulouse, 31059

  • CHU de Nancy - Hôpital de Brabois Adultes

    Vandœuvre-lès-Nancy, 54500

  • CHU de Nancy - Hôpital de Brabois Adultes

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Spain19 sites

  • Hospital Clinic de Barcelona

    Barcelona, 8036

  • Hospital de la Santa Creu I Sant Pau

    Barcelona, 8041

  • Hospital Universitario Del Vinalopo

    Elche, 03001

  • Hospital General Universitario de Elche

    Elche, 3203

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014

  • Hospital Universitario Ciudad de Jaen

    Jaén, 23007

  • Hospital Universitario Lucus Augusti

    Lugo, 27003

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Clinica Universidad de Navarra

    Madrid, 28027

  • Hospital Universitario Infanta Leonor

    Madrid, 28031

  • MD Anderson Cancer Centre

    Madrid, 28033

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28220

  • Complejo Hospitalario Universitario de Orense

    Ourense, 32005

  • Clinica Universidad de Navarra

    Pamplona, 31008

  • Corporacio Sanitaria Parc Tauli

    Sabadell, 8208

  • Hospital Universitario Marques de Valdecilla

    Santander, 39012

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, 15706

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

Other trials in Spain

Japan16 sites

  • Chibaken Saiseikai Narashino Hospital

    Chiba, 275-0006

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Tokai University Hospital

    Isehara, 259-1193

  • Yokohama Minami Kyosai Hospital

    Kanagawa, 236-0037

  • Kobe University Hospital

    Kobe, 650-0017

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Kyoto University Hospital

    Kyoto, 606-8507

  • Mie University Hospital

    Mie, 514-8507

  • Tokyo Saiseikai Central Hospital

    Minatoku, 108-0073

  • Tohoku University Graduate School of Medicine

    Miyagi, 980-8574

  • Okayama Medical Center

    Okayama, 7011192

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • International University of Health and Welfare MITA Hospital

    Tokyo, 108-8329

  • Juntendo University Hospital

    Tokyo, 113-8421

  • Kyorin University Hospital

    Tokyo, 181-8611

  • National Cancer Center Hospital

    Tsukiji, Tokyo, 104-0045

Other trials in Japan

Netherlands14 sites

  • Meander Medisch Centrum

    Amersfoort, 1066 EC

  • Meander Medisch Centrum

    Amersfoort, 3813

  • Onze Lieve Vrouwe Gasthuis, Locatie Oost

    Amsterdam, 1091 AC

  • Onze Lieve Vrouwe Gasthuis, Locatie Oost

    Amsterdam, 1091

  • Rode Kruis Ziekenhuis

    Beverwijk, 1942

  • Albert Schweitzer Ziekenhuis, Dordwijk

    Dordrecht, 3317

  • Universitair Medisch Centrum Groningen

    Groningen, 9713

  • Tergooiziekenhuizen, Hilversum

    Hilversum, 1213

  • Amsterdam University Medical Center

    Holland, 1105AZ

  • Spaarne Gasthuis (Kennemer Gasthuis) - Haarlem-Zuid

    Hoofddorp, 2134TM

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA

  • Radboud Universitair Medisch Centrum

    Nijmegen, 6525

  • Ikazia Ziekenhuis

    Rotterdam, 3083 AN

  • Haga Ziekenhuis

    The Hague, 2545 AA

Other trials in Netherlands

China13 sites

  • Beijing Shijitan Hosp.

    Beijing, 100038

  • Peking University Third Hospital

    Beijing, 100191

  • Jilin Province Tumor Hospital

    Ch’ang-ch’un, 130012

  • Southern Medical University - Zhujiang Hospital

    Guangdong, 510280

  • Nanfang Hospital of Southern Medical University

    Guangzhou, 510515

  • The Sixth Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, 510655

  • Huizhou Municipal Central Hospital

    Huizhou, 516001

  • Nanjing First Hospital

    Nanjing, 210006

  • Jiangsu Province Hospital

    Nanjing, 210029

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

  • Union Hospital Tongji Medical College Huazhong University of Science &Technology

    Wuhan, 430023

  • Tongji Hospital, Tongji Medical College

    Wuhan, 430030

  • 1st Affiliate Hospital of Xi'an Jiao

    Xi'an, 710061

Other trials in China

Canada11 sites

  • University of Calgary

    Calgary, Alberta, T2N 1N4

  • University of Alberta Hospital

    Edmonton, Alberta, T6G2V2

  • Hamilton Health Sciences, Juravinski Hospital and Cancer Centre

    Hamilton, Ontario, L8V 1C3

  • Jewish General Hospital

    Montreal, Quebec, H3T-1E2

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • Queen Elizabeth II Health Sciences Centre

    Nova Scotia, B3H 2Y9

  • Ottawa Hospital

    Ottawa, Ontario, K1H BL6

  • McGill University Health Centre

    Québec, H4A 3J1

  • Niagara Health System

    Saint Catharines, Ontario, L2S 0A9

  • Sault Area Hospital

    Sault Ste. Marie, Ontario, P6A 0A8

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

Other trials in Canada

South Korea11 sites

  • Hallym University Sacred Heart Hospital

    Anyang, 14068

  • SoonChunHyang University Hospital Bucheon

    Bucheon-si, 14584

  • Daegu Catholic University Medical Center

    Daegu, 42472

  • Myongji Hospital

    Goyang-si, Gyeonggi-do, 10475

  • Jeonbuk National University Hospital

    Jeonju, 54907

  • Dong-A University Hospital

    Seogu, 49201

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Soonchunhyang University Seoul Hospital

    Seoul, 4401

  • Ewha Womans University Mokdong Hospital

    Yangcheon, 07985

  • Yongin Severance Hospital, Yonsei University Health System

    Yongin-si, Gyeonggi-do, 16995

  • Soonchunhyang University Seoul Hospital

    Yongsan, 04401

Other trials in South Korea

Australia8 sites

  • Blacktown Hospital

    Blacktown, New South Wales, 2148

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Monash Medical Centre Clayton

    Clayton, Victoria, 3168

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Northern Health

    Epping, Victoria, 3076

  • Perth Blood Institute

    Perth, 6005

  • The Alfred Hospital

    Prahran, 3181

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Germany8 sites

  • Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt

    Dresden, 1067

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, 1307

  • Praxis für Gefäßmedizin

    Görlitz, 2827

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Universitätsklinik der Christian-Albrechts-Universität

    Kiel, 24105

  • Universitätsklinik Leipzig

    Leipzig, 4103

  • Universitaetsklinikum Magdeburg A.oe.R

    Magdeburg, 39120

  • Klinikum der Universitaet Muenchen

    München, 80336

Other trials in Germany

Taiwan8 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Far Eastern Memorial Hospital

    New Taipei City, 220

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 70403

  • National Taiwan University Hospital

    Taipei, 100

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 112

  • Tri-Service General Hospital

    Taipei, 114

Other trials in Taiwan

United Kingdom7 sites

  • University Hospital of Wales

    Cardiff, England, CF14 4XW

  • Castle Hill Hospital, Department of Oncology & Haematology

    Cottingham, ENG, HU16 5JQ

  • Queen Elizabeth University Hospital Campus

    Glasgow, SCO, G514TF

  • Barts Health NHS Trust

    London, ENG, E1 188

  • The Newcastle Upon Tyne Hospitals

    Newcastle upon Tyne, ENG, NE7 7DN

  • University Hospitals of North Midlands

    Stafford, England, ST16 3SA

  • University Hospitals of North Midlands

    Stoke-on-Trent, England, ST4 6QG

Other trials in United Kingdom

Czechia5 sites

  • Masarykuv onkologicky ustav

    Brno, 65653

  • University Hospital Hradec Kralove

    Hradec Králové, 50005

  • Nemocnice Na Pleši s.r.o.

    Nová Ves pod Pleší, 26204

  • Onkologická klinika VFN a 1. LF UK

    Prague, 128 08

  • Thomayerova nemocnice

    Prague, 14059

Other trials in Czechia

Ireland5 sites

  • Bon Secour Hospital

    Cork

  • Cork University Hospital

    Cork

  • Beaumont Hospital

    Dublin, V2N0

  • Msdyrt Midericordiae University Hospital

    Dublin

  • University Hospital, Limerick

    Limerick, V94 T9PX

Other trials in Ireland

Austria3 sites

  • LKH - Universitätsklinikum Graz

    Graz, 8010

  • LK Wiener Neustadt

    Neustadt, 2700

  • Medical University of Vienna

    Vienna, 1090

Other trials in Austria

Hungary3 sites

  • Debreceni Egyetem

    Debrecen, H-4032

  • Markhot Ferenc Oktatokorhaz es Rendelointezet

    Eger, H-3300

  • Bacs-Kiskun County Hospital

    Kecskemét, 6000

Other trials in Hungary

Latvia3 sites

  • Daugavpils Regional Hospital

    Daugavpils, LV-5417

  • Liepaja Regional Hospital

    Liepāja, LV3414

  • Pauls Stradins Clinical University Hospital

    Riga, LV-1002

Other trials in Latvia

Switzerland3 sites

  • Hopital Universitaire Geneve

    Geneva, 1205

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011

  • University of Zürich

    Zurich, 8091

Other trials in Switzerland

Norway2 sites

  • Østfold Hospital Kalnes

    Fredrikstad, 1603

  • Akershus Univeristy Hospital

    Lørenskog, 1478

Other trials in Norway

Sweden1 site

  • Länssjukhuset Sundsvall-Härnösand

    Sundsvall, 85186

Other trials in Sweden

About this study

Official title: 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)

Read the 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

Being tested
Abelacimab, Apixaban
Keywords
Anticoagulants, VTE recurrence rate, PROBE design, LMWH, CAT, Cancer associated VTE, Abelacimab, Apixaban, FXI, Major bleeding events, CRNM bleeding events
Medical subject headings
Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbelacimabBiological

    Also called MAA868

    Abelacimab 150 mg

  • ApixabanDrug

    Also called Eliquis

    Apixaban 10 mg followed by 5 mg

Study groups in NCT05171049
Study groupRoleWhat they receive
AbelacimabExperimentalAbelacimab intravenous administration followed by monthly administration of the same dose subcutaneously
Receives: Biological: Abelacimab
ApixabanActive comparatorApixaban administered orally twice a day
Receives: Drug: Apixaban

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first event of centrally adjudicated VTE recurrence

    Time to first event of centrally adjudicated venous thromboembolism (VTE) recurrence

    Measured: Up to 6 months

Secondary outcomes (8)

  1. 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

    Measured: Up to 6 months

  2. 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

    Measured: Up to 6 months

  3. Time to event of permanent treatment discontinuation not due to death

    Time to permanent discontinuation not due to death

    Measured: Up to 6 months

  4. 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

    Measured: Up to 6 months

  5. Time to first event of ISTH-adjudicated major bleeding events

    Time to first adjudicated major bleeding event

    Measured: Up to 6 months

  6. 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

    Measured: Up to 6 months

  7. 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

    Measured: Up to 6 months

  8. For patients treated with abelacimab: percent with injection site reactions/severity, hypersensitivity reactions/severity, anti-drug antibody formation, neutralizing antibody

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2021
  2. Study start5 May 2022
  3. Primary completion4 Feb 2026
  4. Study completion4 Feb 2026

Why it stopped: Sponsor decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05171049
Sponsor's protocol ID
ANT-007
Other IDs
2023-509569-19-00, CMAA868D12302, 2023
Acronym
ASTER
Status last verified
Feb 2026
First submitted
22 Nov 2021
Last updated
23 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abelacimab and Apixaban in people with Venous Thromboembolism and Deep Venous Thrombosis, run by Anthos Therapeutics, Inc. at 209 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 209 sites in Italy, United States, France, Spain, Japan and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first event of centrally adjudicated VTE recurrence (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05171049.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.

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