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Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT

Primary Purpose

Venous Thromboembolism

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Apixaban 2.5 MG Oral Tablet
Enoxaparin 40Mg/0.4mL Prefilled Syringe
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Apixaban

Enoxaparin

Arm Description

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

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

Outcomes

Primary Outcome Measures

Apixaban vs. Enoxaparin - Bleeding event
To examine the rate of bleeding events in patients receiving oral apixaban versus subcutaneous enoxaparin following microsurgical breast reconstruction

Secondary Outcome Measures

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

Full Information

First Posted
August 5, 2020
Last Updated
August 10, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04504318
Brief Title
Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT
Official Title
A Randomized Controlled Trial Comparing Apixaban Versus Enoxaparin Following Microsurgical Breast Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 12, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Apixaban
Arm Type
Experimental
Arm Description
Patients assigned to this group will receive Apixaban 2.5 mg PO BID starting 12 hours after completing skin closure.
Arm Title
Enoxaparin
Arm Type
Active Comparator
Arm Description
Patients assigned to this group will receive Enoxaparin 40 mg SC QD starting 12 hours after completing skin closure.
Intervention Type
Drug
Intervention Name(s)
Apixaban 2.5 MG Oral Tablet
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Enoxaparin 40Mg/0.4mL Prefilled Syringe
Intervention Description
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.
Primary Outcome Measure Information:
Title
Apixaban vs. Enoxaparin - Bleeding event
Description
To examine the rate of bleeding events in patients receiving oral apixaban versus subcutaneous enoxaparin following microsurgical breast reconstruction
Time Frame
90-day events
Secondary Outcome Measure Information:
Title
Apixaban vs. Enoxaparin - Venous Thromboembolism (VTE) event
Description
To examine the rate of VTE events in patients receiving oral apixaban versus subcutaneous enoxaparin following microsurgical breast reconstruction
Time Frame
90-day events

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arash Momeni, MD
Phone
650-723-6189
Email
smeyer27@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arash Momeni, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arash Momeni, MD
Phone
650-723-6189
Email
smeyer27@stanford.edu

12. IPD Sharing Statement

Learn more about this trial

Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT

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