NCT04504318

Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.
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.

Timeline

• Start date: 2020-08-12
• Primary completion: 2024-06-19
• Completion: 2024-06-19
• First posted: 2020-08-07
• Last updated: 2025-06-22
• Results posted: 2025-06-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study