DOAC - Dosing Options in AntiCoagulation Prophylaxis

Summary

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.

Eligibility

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

Conditions2

Locations1 site

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