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A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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

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

NCT05171049•Anthos Therapeutics, Inc.

View on ClinicalTrials.gov

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)

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+15 more criteria

Locations (209)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

VA Connecticut Healthcare System

West Haven, Connecticut, United States

Washington DC VAMC

Washington D.C., District of Columbia, United States

University of Miami Health

Miami, Florida, United States

NorthShore University Health System

Evanston, Illinois, United States

University of Kentucky, Markey Cancer Center

Lexington, Kentucky, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

Washington University

St Louis, Missouri, United States

Key Dates

Start Date

May 5, 2022

Primary Completion Date

February 4, 2026

Completion Date

February 4, 2026

Last Updated

February 23, 2026

Enrollment

1,150

ACTUAL participants

Conditions

Venous ThromboembolismDeep Venous ThrombosisPulmonary Embolism

Interventions

Abelacimab

BIOLOGICAL

Apixaban

DRUG

Data Clustering Study With Artificial Intelligence and Phenotyping of Patients With Acute Pulmonary Embolism

NCT06183944

Pulmonary Embolism

View study

RECRUITINGNA

CLEANer Aspiration for Pulmonary Embolism

NCT06189313

Pulmonary EmbolismAcute Pulmonary Embolism+2 more

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Data Clustering Study With Artificial Intelligence and Phenotyping of Patients With Acute Pulmonary Embolism

CLEANer Aspiration for Pulmonary Embolism

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