No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
996 (estimated)
Sponsor
University of Vermont · Other
Who this trial is looking for
This trial is looking for people with cancer who are starting or changing treatment. Participants will take a specific blood thinner for 6 months to see if it helps prevent blood clots.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with an active solid tumor or lymphoma.
I am starting a new systemic cancer treatment or changing my treatment.
I have a Khorana Risk Score of 2.
I am not currently on therapeutic anticoagulation.
I am able to provide informed consent.
You may not be able to join if
I have active bleeding or a high risk of bleeding.
I have a known allergy to apixaban.
I am currently on therapeutic-dose anticoagulation for VTE or atrial fibrillation.
My platelet count is below 50,000/µL.
My creatinine clearance is below 25 mL/min.
I have a life expectancy of less than 3 months.
I am pregnant or breastfeeding.
I cannot comply with study procedures.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Blood clots, also known as venous thromboembolism (VTE), are a common and serious complication for people with cancer. They can lead to pain, hospitalizations, delayed cancer treatment, and even death. Although national guidelines recommend using blood thinners (anticoagulants) to prevent clots in cancer patients who are at higher risk, these medications are not commonly prescribed due to concerns…
Blood clots, also known as venous thromboembolism (VTE), are a common and serious complication for people with cancer. They can lead to pain, hospitalizations, delayed cancer treatment, and even death. Although national guidelines recommend using blood thinners (anticoagulants) to prevent clots in cancer patients who are at higher risk, these medications are not commonly prescribed due to concerns about bleeding and inconvenience.
This study will test different ways of using a commonly prescribed blood thinner called apixaban (brand name Eliquis) to see if it can safely and effectively reduce the risk of blood clots and death in cancer patients who are at moderate risk for VTE. The study focuses on people who have a "Khorana score" of 2, which puts them at intermediate risk for developing blood clots.
The study will include approximately 996 participants with solid tumors or lymphoma who are starting or recently started cancer-directed therapy. Participants will be randomly assigned to one of three groups:
Group 1: Apixaban 2.5 mg twice a day (standard prophylactic dose)
Group 2: Apixaban 5 mg once a day (an alternative, more convenient dose)
Group 3: No anticoagulant (standard care)
Participants will take the assigned treatment (if applicable) for 6 months. Researchers will monitor whether participants develop blood clots, experience serious bleeding events, or die from any cause during the study period.
By comparing these three groups, the researchers hope to learn whether a once-daily dose of apixaban can work as well as the standard twice-daily dose, and whether either dosing strategy is better than no anticoagulation at all. If successful, the study may help increase the safe use of VTE prevention in cancer patients and improve overall outcomes, especially in patients at intermediate risk.
This is a pragmatic trial, meaning it is designed to fit into real-world clinical practice with minimal extra procedures. The study drug is not provided by the sponsor and will be prescribed and filled through usual care channels. Participants and their doctors will decide whether to continue the medication after the study ends.
Trial Locations
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Eligibility 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 anticoa…
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
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