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Anticoagulant

Apixaban vs Enoxaparin for Blood Clot Prevention After Breast Reconstruction

Phase 1 & 2
Waitlist Available
Led By Arash Momeni, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Major neurosurgical intervention (brain/spine) within the past 90 days
Active bleeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90-day events
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether direct oral anticoagulants are more effective than subcutaneous enoxaparin at preventing blood clots in patients undergoing autologous breast reconstruction.

Who is the study for?
This trial is for adult women over 18 who are scheduled for certain types of microsurgical breast reconstruction and have a moderate to high risk of blood clots. They must not have any issues with bleeding, severe kidney or liver disease, recent major neurosurgery or eye surgery, uncontrolled high blood pressure, or a history of substance abuse.
What is being tested?
The study compares two blood clot prevention medications after breast reconstruction surgery: Apixaban (an oral tablet) and Enoxaparin (a pre-filled syringe injection). It aims to see if Apixaban is more effective and less invasive than the current standard treatment with Enoxaparin.
What are the potential side effects?
Possible side effects include bleeding complications, allergic reactions at the injection site for Enoxaparin, gastrointestinal issues like nausea or stomach pain, potential increase in liver enzymes with Apixaban use, and rare but serious risks of spinal/epidural hematoma.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman over 18 years old.
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I am scheduled for breast reconstruction using tissue from my abdomen.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had major brain or spine surgery in the last 3 months.
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I am currently experiencing active bleeding.
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I need medication to prevent blood clots.
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My blood pressure is not controlled by medication.
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My kidney function is reduced with creatinine clearance below 30 mL/min or serum creatinine above 1.6 mg/dL.
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I cannot take apixaban or enoxaparin due to health reasons.
Select...
I have a history of bleeding disorders.
Select...
I have a history of blood clotting disorders.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90-day events
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90-day events for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Apixaban vs. Enoxaparin - Bleeding event
Secondary study objectives
Apixaban vs. Enoxaparin - Venous Thromboembolism (VTE) event

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ApixabanExperimental Treatment1 Intervention
Patients assigned to this group will receive Apixaban 2.5 mg PO BID starting 12 hours after completing skin closure.
Group II: EnoxaparinActive Control1 Intervention
Patients assigned to this group will receive Enoxaparin 40 mg SC QD starting 12 hours after completing skin closure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apixaban 2.5 MG Oral Tablet
2020
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,491 Previous Clinical Trials
17,518,082 Total Patients Enrolled
3 Trials studying Deep Vein Thrombosis
295 Patients Enrolled for Deep Vein Thrombosis
Arash Momeni, MDPrincipal Investigator - Stanford University
Stanford Hospital
UniforMedical Services University Of The Hlth Sci (Medical School)
David Grant Usaf Medical Center (Residency)
2 Previous Clinical Trials
130 Total Patients Enrolled

Media Library

Apixaban (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT04504318 — Phase 1 & 2
Deep Vein Thrombosis Research Study Groups: Enoxaparin, Apixaban
Deep Vein Thrombosis Clinical Trial 2023: Apixaban Highlights & Side Effects. Trial Name: NCT04504318 — Phase 1 & 2
Apixaban (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04504318 — Phase 1 & 2
~15 spots leftby Dec 2025
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