Heart and Blood Diseases

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Enoxaparin

Apixaban

Enoxaparin sodium

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Oral apixaban 2.5 mg tablet twice daily for 28 days post-surgery

Subcutaneous enoxaparin 40mg once daily (QD) for 28 days post-surgery.

To evaluate the incidence of major bleeding (including CRNM bleeding) events in women undergoing surgery for gynecologic cancer with apixaban 2.5 mg BID compared to current standard of care, subcutaneous enoxaparin 40 mg QD for 28 days post surgery.

Oral apixaban

Subcutaneous enoxaparin

Saketh Guntupalli, MD

The study will evaluate the incidence of major bleeding (including clinically relevant non-major (CRNM) bleeding) events in women undergoing surgery for gynecologic cancer with apixaban 2.5 mg twice a day (BID) compared to current standard of care, subcutaneous enoxaparin 40 mg once a day (QD) for 28 days post surgery.

Apixaban (Eliquis) is an oral anticoagulant for the treatment and prevention of thromboembolic events. It is advantageous as there is no need to perform routine blood monitoring tests including, international normalized ratio (INR), partial thromboplastin time (PTT) and Factor Xa, to determine clotting in participants receiving treatment. Several studies have shown the efficacy of apixaban for the treatment and prevention of a venous thromboembolism (VTE).

We anticipate that the same efficacy could be replicated in the prevention of VTE in women undergoing surgery for gynecologic cancer. An oral-anticoagulant for standard treatment for prevention of VTE outcomes following surgery could help improve the surgical mortalities associated with gynecologic oncology surgical patients, improve patient adherence for outpatient treatment, and reduce VTE surveillance and outcomes.

Oral Apixaban (Eliquis) Versus Enoxaparin (Lovenox) for Thromboprophylaxis in Women With Suspected Pelvic Malignancy

The Safety of Oral Apixaban (Eliquis) Versus Subcutaneous Enoxaparin (Lovenox) for Thromboprophylaxis in Women With Suspected Pelvic Malignancy; a Prospective Randomized Open Blinded End-point (PROBE) Design

The International Society on Thrombosis and Hemostasis criteria (ISTH) will be used to assess incidence of major bleeding. Participants were monitored for up to 90 days. This is the number of participants who have had at least one major bleeding incidence during the time of observation.

Participants were monitored for up to 90 days. This is the number of participants with bleeding events that did not meet the ISTH criteria but still required intervention. This is the number of participants who had at least one non-major bleeding event during the time of observation.

Participants were monitored for up to 90 days. Both DVTs and PEs will be measured using the Wells criteria, ultrasound, and/or CT. This is the number of participants who had at least one DVT or PE during the time of observation.

Participants were monitored for up to 28 days. This was measured through self-report, patient diaries, and the return of all medication bottles/syringes. This was the number of participants that did not miss more than 2 days of study medication over 28 days (less than 4 pills or 2 injections missed).

Participants were monitored at the 28 (+/- 4) day post-op visit. This was measured through administering a participant satisfaction questionnaire ranging from strongly agree to strongly disagree.This is the number of participants that completed the questionnaire in response to agreeing it was difficult to remember to take the medication, agreeing that there was pain associated with the medication, and agreeing that the medication was easy to use.

This was measured through a validated health survey (SF-8™) provided by a healthcare company (Optum®), which measured overall physical and mental well-being, with responses ranging from none to very, not at all to extremely, etc. Change was calculated as the difference at baseline versus 28 days post op. The score was 0-100 and a higher score was considered a better outcome.

Bristol-Myers Squibb

University of Colorado, Denver

Oral apixaban 2.5 mg tablet twice daily for 28 days post-surgery

Oral apixaban: To evaluate the incidence of major bleeding (including CRNM bleeding) events in women undergoing surgery for gynecologic cancer with apixaban 2.5 mg BID compared to current standard of care, subcutaneous enoxaparin 40 mg QD for 28 days post surgery.

Oral Apixaban

Subcutaneous enoxaparin 40mg once daily (QD) for 28 days post-surgery.

Subcutaneous enoxaparin: To evaluate the incidence of major bleeding (including CRNM bleeding) events in women undergoing surgery for gynecologic cancer with apixaban 2.5 mg BID compared to current standard of care, subcutaneous enoxaparin 40 mg QD for 28 days post surgery.

Subcutaneous Enoxaparin

Total

Age, Continuous

Sex: Female, Male

Race/ethnic group

Race/Ethnicity, Customized

Surgical Intervention

total abdominal hysterectomy(TAH) with BSO/USO

total abdominal hysterectomy (w/out ovaries)

Bilateral/uni salpingo-oophorectomy(BSO)/USO

Radical Hysterectomy

Lymph Node Dissection

Bowel Resection

Removal of Omentum

Surgical Complication

Surgeries

Length of Surgery

Confirm Origin

Stage

Body-mass index

Dr. Saketh Guntupalli

Number of Participants With Incidence of Major Bleeding

Number of Participants With Incidence of Clinically Relevant Non Major Bleeding Events

Number of Participants With Incidence of Venous Thromboembolism (VTEs): Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)

Number of Participants Who Met Medication Adherence Rates

Difficult remembering to take medication

Pain associated with taking the medication

Was medication easy to take

One patient did not answer the "pain associated with taking the medication" category.

Number of Participants With a Patient Satisfaction Assessment

physical score-baseline

physical score-visit 4

Physical change

mental score-baseline

mental score-visit 4

Mental change

Change in Quality of Life From Baseline to 28 Days Post-op

Oral apixaban 2.5 mg tablet twice daily for 28 days post-surgery

Oral apixaban: To evaluate the incidence of major bleeding (including clinically relevant non-major (CRNM) bleeding) events in women undergoing surgery for gynecologic cancer with apixaban 2.5 mg twice a day (BID) compared to current standard of care, subcutaneous enoxaparin 40 mg QD for 28 days post surgery.

Overall Study

Spots Global Cancer Trial Database for oral apixaban