Actively Recruiting
A Comparison of Anticoagulant Dosing Strategies to Reduce VTE and Mortality in Cancer Outpatients: A Randomized, Pragmatic Trial
Led by University of Vermont · Updated on 2026-02-05
996
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Blood clots, known as venous thromboembolism (VTE), are a serious complication for people with cancer, leading to pain, hospitalizations, delayed treatment, and even death. This research aims to compare different dosing strategies of a common blood thinner called apixaban to see if it can safely reduce the risk of blood clots and death in cancer patients at moderate risk, specifically those with a Khorana Risk Score of 2. The study is a phase III pragmatic clinical trial designed to fit real-world practice with minimal extra procedures. Participants will be randomly assigned to one of three groups: apixaban 2.5 mg twice daily, apixaban 5 mg once daily, or no anticoagulant (standard care). The assigned treatment will be taken for 6 months, with participants continuing their usual cancer therapy. Apixaban will be prescribed and filled through regular clinical care, and no study-mandated visits or labs beyond standard care are required. This design helps evaluate if a once-daily dose can improve adherence while maintaining protection compared to the standard twice-daily dose or no anticoagulation. During the study, researchers will monitor participants for blood clots, serious bleeding events, and death through medical records and patient questionnaires. There is a brief patient-reported outcomes check-in at 2 months, but otherwise, data collection is done through routine care documentation. The study will assess the incidence of VTE and mortality over the 6-month period, aiming to provide real-world evidence to guide anticoagulant use in moderate-risk cancer patients. Participants and their doctors will decide on continuing the medication after the study ends.
CONDITIONS
Brief Title
DOAC - Dosing Options in AntiCoagulation Prophylaxis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with an active solid tumor or lymphoma
- Starting a new systemic cancer treatment or changing cancer treatment
- Khorana Risk Score of 2
- Not currently receiving therapeutic anticoagulation
- Able to provide informed consent
You will not qualify if you...
- Active bleeding or high risk of bleeding (e.g., recent major surgery, brain tumors with bleeding risk)
- Known allergy or contraindication to apixaban
- Current therapeutic-dose anticoagulation for blood clots or atrial fibrillation
- Platelet count less than 50,000/µL
- Creatinine clearance less than 25 mL/min
- Life expectancy less than 3 months
- Pregnant or breastfeeding
- Inability to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive apixaban either 2.5 mg twice daily or 5 mg once daily, or no anticoagulant prophylaxis, for VTE prevention while continuing their cancer therapy.
1 patient-reported outcomes check-in at 2 months; all other data collected through routine care and electronic health records
Trial Site Locations
Total: 1 location
1
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Actively Recruiting
Research Team
S
Steven Ades, MD, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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