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Anticoagulant

Apixaban vs Enoxaparin for Blood Clot Prevention After Breast Reconstruction

Phase 1 & 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90-day events

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90-day events

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Apixaban vs. Enoxaparin - Bleeding event

Secondary outcome measures

Apixaban vs. Enoxaparin - Venous Thromboembolism (VTE) event

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,249 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the requirements to be accepted into this clinical experiment?

"The study, which is searching for 106 participants with venous thromboembolism aged 18-89, must meet certain criteria. These include a Caprini score of 6 or higher, being female adults (18+), and meeting the necessary requirements to undergo unilateral or bilateral microsurgical breast reconstruction with free abdominal flaps such as muscle-sparing transverse rectus abdominis musculocutaneous [TRAM] and/or deep inferior epigastric artery perforator [DIEP]) flap)."

Answered by AI

Are individuals of less than four decades old viable candidates for this investigation?

"Applicants for this trial must be nonagenarians or younger and have attained the age of majority."

Answered by AI

How many participants has this clinical investigation accepted so far?

"Confirmed. The information located on clinicaltrials.gov affirms that this research is recruiting participants, with a posting date of August 12th 2020 and an update made on March 16th 2022. 106 individuals are sought for the study from a single site."

Answered by AI

What is the typical purpose of Apixaban 2.5 MG Oral Tablet?

"Apixaban 2.5 MG Oral Tablet is frequently prescribed as a preventative measure against deep vein thrombosis, although it can also be utilized to treat atrial fibrillation and other medical conditions both inpatients and outpatients face alike."

Answered by AI

Are any additional participants being admitted for this clinical trial?

"Indeed, clinicaltrials.gov confirms that this investigation is presently searching for participants. The experiment was initially added on August 12th 2020 and recently revised on March 16th 2022. 106 volunteers need to be enlisted from 1 medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT

Arash Momeni 2020. "Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04504318.

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