Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT

Phase 1

Completed

• Conditions: Venous Thromboembolism
• Interventions: Drug: Enoxaparin 40Mg/0.4mL Prefilled Syringe; Drug: Apixaban 2.5 MG Oral Tablet

• Registration Number: NCT04504318
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-08-05
• Study First Posted: 2020-08-07
• Study Start: 2020-08-12
• Primary Completion: 2024-06-19
• Study Completion: 2024-06-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enoxaparin	Enoxaparin 40Mg/0.4mL Prefilled Syringe	Patients assigned to this group will receive Enoxaparin 40 mg SC QD starting 12 hours after completing skin closure.
Apixaban	Apixaban 2.5 MG Oral Tablet	Patients assigned to this group will receive Apixaban 2.5 mg PO BID starting 12 hours after completing skin closure.

Primary Outcome Measures

Name	Time	Method
Apixaban vs. Enoxaparin - Bleeding event	90-day events	To examine the rate of bleeding events in patients receiving oral apixaban versus subcutaneous enoxaparin following microsurgical breast reconstruction

Secondary Outcome Measures

Name	Time	Method
Apixaban vs. Enoxaparin - Venous Thromboembolism (VTE) event	90-day events	To examine the rate of VTE events in patients receiving oral apixaban versus subcutaneous enoxaparin following microsurgical breast reconstruction

Trial Locations

Locations (1)

Stanford University Medical Center; 🇺🇸 Stanford, California, United States