This phase I/II trial studies the effect of apixaban or enoxaparin in preventing blood clot in patients undergoing breast reconstruction. Apixaban and enoxaparin are anticoagulant drugs that prevent blood clot. Giving apixaban or enoxaparin after breast reconstruction surgery may prevent blood clot that starts in the vein.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04504318.
PRIMARY OBJECTIVE:
I. To examine the rate of bleeding events in patients receiving oral apixaban versus subcutaneous enoxaparin
SECONDARY OBJECTIVE:
I. To examine the rate of venous thromboembolism (VTE) events in patients receiving oral apixaban versus subcutaneous enoxaparin.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Starting 12 hours after completing skin closure, patients receive apixaban orally (PO) twice daily (BID) up to time of inpatient discharge in the absence of unacceptable toxicity.
ARM B: Starting 12 hours after completing skin closure, patients receive enoxaparin subcutaneously (SC) once daily (QD) up to time of inpatient discharge in the absence of unacceptable toxicity.
After completion of surgery, patients are followed up at 90 days.
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorArash Momeni
