Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT (NCT04504318) | Clinical Trial Compass
CompletedPhase 1/2
Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT
United States82 participantsStarted 2020-08-12
Plain-language 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.
Who can participate
Age range
18 Years – 89 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Ability to understand and the willingness to sign a written informed consent document.
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
* Pregnant or Nursing
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Apixaban vs. Enoxaparin - Number of Participants With Bleeding Events