Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT

Sponsor
Stanford University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04504318
Collaborator
(none)
106
1
2
35.6
3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Apixaban 2.5 MG Oral Tablet
  • Drug: Enoxaparin 40Mg/0.4mL Prefilled Syringe
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
106 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Care Provider)
Primary Purpose:
Prevention
Official Title:
A Randomized Controlled Trial Comparing Apixaban Versus Enoxaparin Following Microsurgical Breast Reconstruction
Actual Study Start Date :
Aug 12, 2020
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Apixaban

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

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.

Active Comparator: Enoxaparin

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

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 89 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University Medical Center Stanford California United States 94305

Sponsors and Collaborators

  • Stanford University

Investigators

  • Principal Investigator: Arash Momeni, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Arash Momeni, Assistant Professor of Surgery (Plastic Surgery), Stanford University
ClinicalTrials.gov Identifier:
NCT04504318
Other Study ID Numbers:
  • IRB-49355
First Posted:
Aug 7, 2020
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 18, 2022