Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 10 for:    VTE and Breast

Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04504318
Recruitment Status : Recruiting
First Posted : August 7, 2020
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Arash Momeni, Stanford University

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

Layout table for study information
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

Resource links provided by the National Library of Medicine


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.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04504318


Contacts
Layout table for location contacts
Contact: Arash Momeni, MD 650-723-6189 smeyer27@stanford.edu

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Arash Momeni, MD Stanford University
Layout table for additonal 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    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020

Layout table for additional information
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:
Layout table for 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