Apixaban dosing options to prevent blood clots in people with cancer
Official title: A Comparison of Anticoagulant Dosing Strategies to Reduce VTE and Mortality in Cancer Outpatients: A Randomized, Pragmatic Trial
Run by University of Vermont · NCT07005024 · Data updated 2026-11-12
This study will test whether taking apixaban once a day, twice a day, or not taking anticoagulants helps prevent blood clots and death in adults with solid tumors or lymphoma who have a Khorana score of 2.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 996 (estimated) |
| Sponsor | University of Vermont Academic / other |
| Locations | 1 site (Burlington, Vermont) |
| Status | Recruiting |
| Started | October 17, 2025 |
| Main results expected | August 2035 |
| Study ends | August 2035 |
| Registry record updated | February 5, 2026 |
| Trial ID | NCT07005024 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with active solid tumors or lymphoma who have a Khorana score of 2, are starting systemic cancer treatment, are not on therapeutic anticoagulation, and do not have high bleeding risk.
✕Probably not a fit
People with high bleeding risk, severe renal failure, current therapeutic anticoagulation, very short life expectancy, or contraindications to apixaban are unlikely to benefit from this prevention strategy.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, phase III, open-label randomized trial will enroll about 996 adults with active solid tumors or lymphoma who have a Khorana Risk Score of 2 and are starting or recently started systemic cancer therapy. Participants will be randomized 1:1:1 to apixaban 2.5 mg twice daily, apixaban 5 mg once daily, or no anticoagulation and followed for venous thromboembolism, bleeding events, and survival outcomes. The pragmatic design focuses on real-world adherence and net clinical benefit, comparing the standard low-dose twice-daily regimen against a potentially more convenient once-daily option. Major exclusions include active high bleeding risk, severe renal impairment, and current therapeutic anticoagulation.
Why it matters
Potential benefit: If successful, a once-daily apixaban option could lower clot rates while improving medication adherence and uptake of prophylaxis among at-risk cancer patients.
How similar studies have gone: Previous trials like AVERT showed that apixaban 2.5 mg twice daily reduced VTE but increased major bleeding, and once-daily dosing has not been adequately tested in this population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Diagnosed with an active solid tumor or lymphoma * Starting a new systemic cancer treatment or changing cancer treatment * Khorana Risk Score of 2 (calculated based on lab and clinical data at treatment initiation) * Not currently receiving therapeutic anticoagulation * Able to provide informed consent Exclusion Criteria: * Active bleeding or high risk of bleeding (e.g., recent major surgery, CNS tumors with hemorrhagic risk) * Known contraindication to apixaban (e.g., allergy, severe liver disease, dual strong CYP3A4 and P-gp inhibitors) * Current therapeutic-dose anticoagulation for VTE or atrial fibrillation * Platelet count \< 50,000/µL * Creatinine clearance \< 25 mL/min * Life expectancy \< 3 months * Pregnant or breastfeeding * Inability to comply with study procedures
Where it's running
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University of Vermont Medical Center
Burlington, Vermont, United States Recruiting
Study contacts
- Study coordinator: Steven Ades, MD, MSc
- Email: steven.ades@med.uvm.edu
- Phone: 1 (802) 656-2021
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.