drugset / Trial / NCT04504318

Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT

NCT04504318

Phase 1/2 Completed 82 enrolled Stanford University
RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2020-08-12
Primary completion
2024-06-19
Completion
2024-06-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Apixaban Small molecule 2.5 mg Oral
Comparator Enoxaparin sodium Other / unclassified 40 mg Subcutaneous