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Completed

NCT Number: NCT04504318

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.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

18 year–89 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Stanford University Medical Center

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Ability to understand and the willingness to sign a written informed consent document.

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
  • Pregnant or Nursing

Treatment and study plan

Apixaban 2.5 MG Oral Tablet

Drug

Patients will be assigned to the respective study groups postoperatively upon arrival in the post-anesthesia care unit. Hence, surgeons are blinded at the time of surgery as to study group assignment. Chemoprophylaxis will continue for the duration of the hospitalization.

Enoxaparin 40Mg/0.4mL Prefilled Syringe

Drug

Patients will be assigned to the respective study groups postoperatively upon arrival in the post-anesthesia care unit. Hence, surgeons are blinded at the time of surgery as to study group assignment. Chemoprophylaxis will continue for the duration of the hospitalization.

Primary outcomes

  1. Apixaban vs. Enoxaparin - Number of Participants With Bleeding Events

    Time frame: 90-day events

    To examine the rate of bleeding events in patients receiving oral apixaban versus subcutaneous enoxaparin following microsurgical breast reconstruction

Secondary outcomes

  1. Apixaban vs. Enoxaparin - Number of Participants With Venous Thromboembolism (VTE) Events

    Time frame: 90 days

    To examine the rate of VTE events in patients receiving oral apixaban versus subcutaneous enoxaparin following microsurgical breast reconstruction

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

A Randomized Controlled Trial Comparing Apixaban Versus Enoxaparin Following Microsurgical Breast Reconstruction

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 7, 2020
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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