Comparing Apixaban Dosing to Prevent Blood Clots and Death in Cancer Patients A Randomized Trial of Twice-Daily, Once-Daily, or No Anticoagulant Treatment

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.

DOAC - Dosing Options in AntiCoagulation Prophylaxis