Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT

• ClinicalTrials.gov Identifier: NCT04504318
• Recruitment Status: Recruiting
• First Posted: August 7, 2020
• Last Update Posted: October 23, 2020
• Sponsor: Stanford University
• Information provided by (Responsible Party): Arash Momeni, Stanford University

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
Venous Thromboembolism	Drug: Apixaban 2.5 MG Oral Tablet; Drug: Enoxaparin 40Mg/0.4mL Prefilled Syringe	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated 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: August 12, 2020
• Estimated Primary Completion Date: April 2022
• Estimated Study Completion Date: August 2022

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 [ Time Frame: 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 [ Time Frame: 90-day events ]
   To examine the rate of VTE events in patients receiving oral apixaban versus subcutaneous enoxaparin following microsurgical breast reconstruction

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts

Contact: Arash Momeni, MD; 650-723-6189; smeyer27@stanford.edu

Locations

United States, California

Stanford University Medical Center; Recruiting

Stanford, California, United States, 94305

Contact: Arash Momeni, MD 650-723-6189 smeyer27@stanford.edu

Sponsors and Collaborators

Stanford University

Investigators

• Principal Investigator: Arash Momeni, MD; Stanford University

More Information

• Responsible Party: Arash Momeni, Assistant Professor of Surgery (Plastic Surgery), Stanford University
• ClinicalTrials.gov Identifier: NCT04504318
• Other Study ID Numbers: IRB-49355
• First Posted: August 7, 2020
• Last Update Posted: October 23, 2020
• Last Verified: October 2020

• 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:

Thromboembolism; Venous Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Enoxaparin; Apixaban; Anticoagulants; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Protease Inhibitors; Enzyme Inhibitors