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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apixaban | Experimental | Patients assigned to this group will receive Apixaban 2.5 mg PO BID starting 12 hours after completing skin closure. |
|
| Enoxaparin | Active Comparator | Patients assigned to this group will receive Enoxaparin 40 mg SC QD starting 12 hours after completing skin closure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban 2.5 MG Oral Tablet | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Apixaban vs. Enoxaparin - Number of Participants With Bleeding Events | To examine the rate of bleeding events in patients receiving oral apixaban versus subcutaneous enoxaparin following microsurgical breast reconstruction | 90-day events |
| Measure | Description | Time Frame |
|---|---|---|
| Apixaban vs. Enoxaparin - Number of Participants With Venous Thromboembolism (VTE) Events | To examine the rate of VTE events in patients receiving oral apixaban versus subcutaneous enoxaparin following microsurgical breast reconstruction | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arash Momeni, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Stanford | California | 94305 | United States |
82 participants signed informed consent; 76 were allocated to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Apixaban | Patients assigned to this group will receive Apixaban 2.5 mg PO BID starting 12 hours after completing skin closure. |
| FG001 | Enoxaparin | Patients assigned to this group will receive Enoxaparin 40 mg SC QD starting 12 hours after completing skin closure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Apixaban | Patients assigned to this group will receive Apixaban 2.5 mg PO BID starting 12 hours after completing skin closure. |
| BG001 | Enoxaparin | Patients assigned to this group will receive Enoxaparin 40 mg SC QD starting 12 hours after completing skin closure. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Apixaban vs. Enoxaparin - Number of Participants With Bleeding Events | To examine the rate of bleeding events in patients receiving oral apixaban versus subcutaneous enoxaparin following microsurgical breast reconstruction | Posted | Count of Participants | Participants | 90-day events |
|
Adverse event data was collected for 90 days from the surgery date.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Apixaban | Patients assigned to this group will receive Apixaban 2.5 mg PO BID starting 12 hours after completing skin closure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding Event | Surgical and medical procedures | Systematic Assessment | Subject had bleeding event prior to administration of medication |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis at donor site (abdomen) | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Arash Momeni | Stanford University | 650-723-6189 | amomeni@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2022 | May 2, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C522181 | apixaban |
| D013607 | Tablets |
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
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|
| Enoxaparin 40Mg/0.4mL Prefilled Syringe | Drug | 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. |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Apixaban vs. Enoxaparin - Number of Participants With Venous Thromboembolism (VTE) Events | To examine the rate of VTE events in patients receiving oral apixaban versus subcutaneous enoxaparin following microsurgical breast reconstruction | Posted | Count of Participants | Participants | 90 days |
|
|
|
| 0 |
| 37 |
| 1 |
| 37 |
| 6 |
| 37 |
| EG001 | Enoxaparin | Patients assigned to this group will receive Enoxaparin 40 mg SC QD starting 12 hours after completing skin closure. | 0 | 39 | 1 | 39 | 5 | 39 |
|
| Wound dehsicence at breast | Surgical and medical procedures | Systematic Assessment |
|
| Breast Cellulitis | Surgical and medical procedures | Systematic Assessment |
|
| Mastectomy skin necrosis | Surgical and medical procedures | Systematic Assessment |
|
| Wound deshiscence at abdomen | Surgical and medical procedures | Systematic Assessment |
|
| Hematoma | Surgical and medical procedures | Systematic Assessment |
|
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| D006025 |
| Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |