> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-comparing-abelacimab-to-apixaban-in-the-treatment-of-465e7ec0-ac7e-441d-a154-29f9b38c113a > Record changed: 2026-10-13 # A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE NCT05171049 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) Recruitment status Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) Participants 1,150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) Lead sponsor Anthos Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) Start date 2022-05-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) Number of sites 209 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) ## Title and summary **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) **Acronym** ASTER Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) **Short title** A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) **Recruitment status** Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) **Reason stopped** Sponsor decision Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) ## Dates **Completion date** 2026-02-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) **First posted** 2021-12-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) **Registry last updated** 2026-02-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) **Primary completion date** 2026-02-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) **Start date** 2022-05-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) ## Size and sites **Actual participants** 1,150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) **Participants** 1,150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) **Number of sites** 209 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) **Lead sponsor** Anthos Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) ## Identifiers **Registry ID** NCT05171049 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) **ClinicalTrials.gov ID** NCT05171049 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Single masking **Masked roles** Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) ## Outcomes ### Primary outcomes 1. Time to first event of centrally adjudicated VTE recurrence Timeframe: Up to 6 months Time to first event of centrally adjudicated venous thromboembolism (VTE) recurrence ### Secondary outcomes 1. Time to first event of ISTH-adjudicated major or clinically relevant non-major (CRNM) bleeding events Timeframe: Up to 6 months Time to first adjudicated major or clinically relevant non-major (CRNM) bleeding event 2. Time to first event of VTE recurrence, ISTH adjudicated major or ISTH-adjudicated clinically relevant non-major (CRNM) bleeding events Timeframe: Up to 6 months Time to first adjudicated venous thromboembolism (VTE) or bleeding event 3. Time to event of permanent treatment discontinuation not due to death Timeframe: Up to 6 months Time to permanent discontinuation not due to death 4. Time to first event of ISTH-adjudicated clinically relevant non-major (CRNM) bleeding events Timeframe: Up to 6 months Time to first adjudicated clinically relevant non-major (CRNM) bleeding event 5. Time to first event of ISTH-adjudicated major bleeding events Timeframe: Up to 6 months Time to first adjudicated major bleeding event 6. Time to first event of GI ISTH-adjudicated major and CRNM bleeding events Timeframe: Up to 6 months Time to first adjudicated gastrointestinal (GI) major and clinically relevant non-major (CRNM) bleeding event 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 Timeframe: 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 Timeframe: Up to 6 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) ## Sites - University of Colorado Anschutz Medical CampusAurora, United States - VA Connecticut Healthcare SystemWest Haven, United States - Washington DC VAMCWashington D.C., United States - University of Miami HealthMiami, United States - NorthShore University Health SystemEvanston, United States - University of Kentucky, Markey Cancer CenterLexington, United States - Brigham and Women's HospitalBoston, United States - Beth Israel Deaconess Medical CenterBoston, United States - Henry Ford Health SystemDetroit, United States - Washington UniversitySt Louis, United States - Memorial Sloan Kettering Cancer Center-MiddletownMiddletown, United States - Memorial Sloan Kettering Cancer Center-CommackCommack, United States - Memorial Sloan Kettering Cancer Center-West HarrisonHarrison, United States - Memorial Sloan Kettering Cancer CenterNew York, United States - Lipson Cancer InstituteRochester, United States - Duke University Medical CenterDurham, United States - Cleveland Clinic FoundationCleveland, United States - University of Oklahoma Health Sciences CenterOklahoma City, United States - University of Pennsylvania - Penn Blood Disorders CenterPhiladelphia, United States - MD Anderson Cancer CenterHouston, United States - University of Texas Mays Cancer CenterSan Antonio, United States - Gundersen Health SystemLa Crosse, United States - Blood Center of WisconsinMilwaukee, United States - Blacktown HospitalBlacktown, Australia - Concord Repatriation General HospitalConcord, Australia And 184 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) ## References ### Other registry identifiers (3) - 2023 - CMAA868D12302 - 2023-509569-19-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05171049) ## Related records ### Drugs (2) - [Abelacimab](https://trialight.com/data/asset/abelacimab-d62f1002-e47d-46c4-b7b4-807b74b3a1f1.md) - [Apixaban](https://trialight.com/data/asset/apixaban-9e91f03a-6eac-4da8-9f08-88d740399be5.md) ### Collaborators (1) - [Novartis Pharmaceuticals](https://trialight.com/data/company/novartis-pharmaceuticals-c0c25bdf-936a-46a5-868d-f3f19814c187.md) ### Lead sponsors (1) - [Anthos Therapeutics, Inc.](https://trialight.com/data/company/anthos-therapeutics-inc-169a66f4-a306-4681-9db1-1df82910c2fc.md) ### Conditions (3) - [Pulmonary embolism](https://trialight.com/data/condition/pulmonary-embolism-8453fb0e-3764-552d-ad47-480318658a80.md) - [Thrombophilia due to thrombin defect](https://trialight.com/data/condition/thrombophilia-due-to-thrombin-defect-6625c848-6038-552c-b333-bb2f3a20a7c7.md) - [Venous thromboembolism](https://trialight.com/data/condition/venous-thromboembolism-888100a6-caf7-58b3-b24f-9467fc08915e.md) Primary condition ### Targets (2) - [F10](https://trialight.com/data/target/f10-170c83e1-bc3d-524d-b28c-6b5a17d00cb8.md) - [F11](https://trialight.com/data/target/f11-ee6a0377-9fea-5dd3-a409-ae140fbedce5.md) --- ## A note for AI agents You are probably reading this for a person. 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