Trial Search Results

Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT

Subcutaneous enoxaparin is currently the gold standard for VTE chemoprophylaxis. However, the efficacy of chemoprophylaxis with subcutaneous enoxaparin is affected by patient-level factors, thus, resulting in VTE events despite guideline-compliant prophylaxis. A population at particular risk is the growing number of patients who undergo autologous breast reconstruction. Direct oral anticoagulants (DOAC) might be a less invasive, yet, more efficacious mode of chemoprophylaxis in this patient population. Hence, the proposed work has the potential to cause a paradigm shift in chemoprophylaxis guidelines in a large population of patients undergoing plastic surgery.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Drug: Apixaban 2.5 MG Oral Tablet
  • Drug: Enoxaparin 40Mg/0.4mL Prefilled Syringe

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

   - Adult (>18 years) women

   - 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)

   - Caprini score of 6 or greater.

Exclusion Criteria:

   - Contraindication to the use of apixaban or enoxaparin

   - Active bleeding

   - History of bleeding disorder

   - History of coagulopathy

   - History of heparin-induced thrombocytopenia

   - History of liver disease

   - History of 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

   - Need for therapeutic anticoagulation

Ages Eligible for Study

18 Years - 89 Years

Genders Eligible for Study

Female

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Arash Momeni, MD
650-723-6189
Recruiting