Apixaban dosing options to prevent blood clots in people with cancer
A Comparison of Anticoagulant Dosing Strategies to Reduce VTE and Mortality in Cancer Outpatients: A Randomized, Pragmatic Trial
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 |
| Enrollment | 996 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Vermont Academic / other |
| Locations | 1 site (Burlington, Vermont) |
| Trial ID | NCT07005024 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Burlington, Vermont
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.