ASTER - Abelacimab versus apixaban in the treatment of cancer associated VTE
Research type
Research Study
Full 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
IRAS ID
1004588
Contact name
Dan Bloomfield
Contact email
Sponsor organisation
Anthos Therapeutics
Eudract number
2021-003076-14
Clinicaltrials.gov Identifier
Research summary
Cancer is a strong and independent risk factor for thrombosis, most particularly a blood clot called a VTE (venous thromboembolism) which can include a DVT (deep venous thrombosis) which is a clot in leg veins and/or PE (pulmonary embolism), which is a clot in the pulmonary artery in lungs. Standard of care treatments include blood thinners (anticoagulants), such as apixaban (Eliquis®) or low molecular weight heparin, which helps treat blood clots and reduce the risk of complications that blood clots can cause, but they can increase the risk of bleeding. Abelacimab is an experimental drug is being studied for its ability to reduce blood clotting with potentially fewer bleeding events. Abelacimab is an antibody (type of protein made by the immune system) that binds to another protein that plays an important role in blood clot formation.
This is a Phase 3 study and the purpose of this study is to see if patients taking abelacimab have fewer bleeding events compared to those taking apixaban already approved to treat patients with an increased risk of blood clots. Approximately 1600 patients with cancer and recently diagnosed VTE (within 72 hours from diagnosis of the qualifying VTE) will be enrolled across several countries.
The study participation will take approximately 8 months (up to 72 hours of screening, 6 months of active treatment and 2 months of follow up). There will be a number of assessments (medical history, physical exams, vital signs, ECGs, blood/urine samples, and questionnaires) to be completed.REC name
Wales REC 5
REC reference
22/WA/0169
Date of REC Opinion
18 Jul 2022
REC opinion
Further Information Favourable Opinion