Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT

NCT ID: NCT04504318

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-12
• Study Completion Date: 2024-06-19

Brief Summary

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.

Conditions

Venous Thromboembolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Apixaban

Patients assigned to this group will receive Apixaban 2.5 mg PO BID starting 12 hours after completing skin closure.

Group Type: EXPERIMENTAL

Apixaban 2.5 MG Oral Tablet

Intervention Type: 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

Patients assigned to this group will receive Enoxaparin 40 mg SC QD starting 12 hours after completing skin closure.

Group Type: ACTIVE_COMPARATOR

Enoxaparin 40Mg/0.4mL Prefilled Syringe

Intervention Type: 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.

Interventions

Apixaban 2.5 MG Oral Tablet

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.

Intervention Type: DRUG

Enoxaparin 40Mg/0.4mL Prefilled Syringe

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Arash Momeni

Assistant Professor of Surgery (Plastic Surgery)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arash Momeni, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University Medical Center

Stanford, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB-49355

Identifier Type: -

Identifier Source: org_study_id