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NCT04504318 · ClinicalTrials.gov registry record · Phase 1
Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT
A Phase 1 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 1
- Development phase
- 82
- Enrollment target
NCT04504318: Completed Phase 1 study, sponsored by Stanford University.
NCT04504318 is a Phase 1 study that has completed, run by Stanford University. The registered enrollment target is 82 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04504318, a Phase 1 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 82 participants
- Enrollment target
Study 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.
Primary Outcome
To examine the rate of bleeding events in patients receiving oral apixaban versus subcutaneous enoxaparin following microsurgical breast reconstruction
Interventions
- DRUG Apixaban 2.5 MG Oral Tablet
- DRUG Enoxaparin 40Mg/0.4mL Prefilled Syringe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2020-08-12 |
| Est. Completion | 2024-06-19 |
| Phase | Phase 1 |
What the finished NCT04504318 record still lists
NCT04504318 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% higher).
The record links to 0 conditions, and to 2 interventions - of which Apixaban 2.5 MG Oral Tablet is the first listed.
NCT04504318 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04504318 about?
NCT04504318 is a clinical study titled "Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT". 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 ...
What is the current status of trial NCT04504318?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 82 participants. The study started on 2020-08-12. Estimated completion is 2024-06-19.
What interventions are being tested in trial NCT04504318?
The interventions under investigation include: Apixaban 2.5 MG Oral Tablet (DRUG), Enoxaparin 40Mg/0.4mL Prefilled Syringe (DRUG).
Who is sponsoring clinical trial NCT04504318?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04504318's enrollment target sits among peer trials
82 669th of 2000 higher than 1,330 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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