Apixaban or Enoxaparin for the Prevention of Blood Clot in Patients Undergoing Breast Reconstruction
- Adult (> 18 years) women who are scheduled to undergo unilateral or bilateral microsurgical breast reconstruction with free abdominal flaps (i.e. muscle-sparing transverse rectus abdominis musculocutaneous [TRAM] and/or deep inferior epigastric artery perforator [DIEP]) flap) and who are found to have a Caprini score of >= 6
- Ability to understand and the willingness to sign a written informed consent document
- Nonsteroidal antiinflammatory drugs (NSAIDs) or other anticoagulant intake within 7 days of surgery
- Use of other investigational agents is prohibited
- Active bleeding, history of bleeding disorder, coagulopathy, heparin-induced thrombocytopenia, liver disease, renal disease (creatinine clearance =< 30 mL/min; serum creatinine > 1.6 mg/dL), major neurosurgical intervention (brain/spine) within the past 90 days, ophthalmologic procedure within the past 90 days, uncontrolled hypertension, history of alcohol and/or substance abuse, or need for therapeutic anticoagulation
- Contraindication to the use of apixaban or enoxaparin
- Pregnant or nursing patients will be excluded from the study
I. To examine the rate of bleeding events in patients receiving oral apixaban versus subcutaneous enoxaparin
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.
Trial Phase Phase I/II
Trial Type Prevention
Stanford Cancer Institute Palo Alto
- Primary ID BRS0110
- Secondary IDs NCI-2021-01758
- Clinicaltrials.gov ID NCT04504318