Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT

Venous Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04504318
• Other study ID #: IRB-49355
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 12, 2020
• Est. completion date: August 1, 2024

Study information

• Verified date: May 2024
• Source: Stanford University
• Contact: Arash Momeni, MD
• Phone: 650-723-6189
• Email: amomeni[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apixaban vs. Enoxaparin - Bleeding event	To examine the rate of bleeding events in patients receiving oral apixaban versus subcutaneous enoxaparin following microsurgical breast reconstruction	90-day events
Secondary	Apixaban vs. Enoxaparin - Venous Thromboembolism (VTE) event	To examine the rate of VTE events in patients receiving oral apixaban versus subcutaneous enoxaparin following microsurgical breast reconstruction	90-day events