Trial Outcomes & Findings for Oral Apixaban (Eliquis) Versus Enoxaparin (Lovenox) for Thromboprophylaxis in Women With Suspected Pelvic Malignancy (NCT NCT02366871)

Last Updated: 2020-03-31

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

400 participants

Primary outcome timeframe

Day 1 post-op/standard of care first medication dose to day 90 (+/-14 days) post-op/standard of care

Results posted on

2020-03-31

Participant Flow

Participant milestones

Participant milestones
Measure	Oral Apixaban 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.	Subcutaneous Enoxaparin 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.
Overall Study STARTED	204	196
Overall Study COMPLETED	204	196
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oral Apixaban n=204 Participants 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.	Subcutaneous Enoxaparin n=196 Participants 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.	Total n=400 Participants Total of all reporting groups
Age, Continuous	58.0 years n=5 Participants	58.5 years n=7 Participants	58.0 years n=5 Participants
Sex: Female, Male Female	204 Participants n=5 Participants	196 Participants n=7 Participants	400 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnic group · White Non-Hispanic	158 Participants n=5 Participants	164 Participants n=7 Participants	322 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnic group · Hispanic	38 Participants n=5 Participants	23 Participants n=7 Participants	61 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnic group · African American	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnic group · Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Surgical Intervention Open	165 Participants n=5 Participants	152 Participants n=7 Participants	317 Participants n=5 Participants
Surgical Intervention Minimally Invasive	39 Participants n=5 Participants	44 Participants n=7 Participants	83 Participants n=5 Participants
Surgeries total abdominal hysterectomy(TAH) with BSO/USO	116 Participants n=5 Participants	112 Participants n=7 Participants	228 Participants n=5 Participants
Surgeries total abdominal hysterectomy (w/out ovaries)	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Surgeries Bilateral/uni salpingo-oophorectomy(BSO)/USO	42 Participants n=5 Participants	49 Participants n=7 Participants	91 Participants n=5 Participants
Surgeries Radical Hysterectomy	18 Participants n=5 Participants	24 Participants n=7 Participants	42 Participants n=5 Participants
Surgeries Lymph Node Dissection	93 Participants n=5 Participants	88 Participants n=7 Participants	181 Participants n=5 Participants
Surgeries Bowel Resection	25 Participants n=5 Participants	12 Participants n=7 Participants	37 Participants n=5 Participants
Surgeries Removal of Omentum	82 Participants n=5 Participants	82 Participants n=7 Participants	164 Participants n=5 Participants
Surgeries Surgical Complication	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Length of Surgery	204 minutes n=5 Participants	215.5 minutes n=7 Participants	209 minutes n=5 Participants
Confirm Origin Uterine Cancer	65 Participants n=5 Participants	63 Participants n=7 Participants	128 Participants n=5 Participants
Confirm Origin Ovarian/Fallopian Cancer	77 Participants n=5 Participants	64 Participants n=7 Participants	141 Participants n=5 Participants
Confirm Origin Cervical Cancer	12 Participants n=5 Participants	18 Participants n=7 Participants	30 Participants n=5 Participants
Confirm Origin Vulva/Vaginal Cancer	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Confirm Origin Other	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Confirm Origin Benign	40 Participants n=5 Participants	37 Participants n=7 Participants	77 Participants n=5 Participants
Stage Low stage (I/II)	80 Participants n=5 Participants	85 Participants n=7 Participants	165 Participants n=5 Participants
Stage High stage (III/IV)	84 Participants n=5 Participants	74 Participants n=7 Participants	158 Participants n=5 Participants
Stage Benign	40 Participants n=5 Participants	37 Participants n=7 Participants	77 Participants n=5 Participants
Body-mass index	27.4 kg/m^2 n=5 Participants	26.5 kg/m^2 n=7 Participants	27.0 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: Day 1 post-op/standard of care first medication dose to day 90 (+/-14 days) post-op/standard of care

Outcome measures

Outcome measures
Measure	Oral Apixaban n=204 Participants 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.	Subcutaneous Enoxaparin n=196 Participants 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.
Number of Participants With Incidence of Major Bleeding	1 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 1 post-op/standard of care first dose of medication to day 90 (+/- 14 days) post-op/standard of care

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.

Outcome measures

Outcome measures
Measure	Oral Apixaban n=204 Participants 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.	Subcutaneous Enoxaparin n=196 Participants 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.
Number of Participants With Incidence of Clinically Relevant Non Major Bleeding Events	12 Participants	19 Participants

SECONDARY outcome

Timeframe: Day 1 post-op/standard of care to day first dose of medication 90 (+/- 14 days) post-op/standard of care

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.

Outcome measures

Outcome measures
Measure	Oral Apixaban n=204 Participants 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.	Subcutaneous Enoxaparin n=196 Participants 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.
Number of Participants With Incidence of Venous Thromboembolism (VTEs): Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Day 1 post-op/standard of care first dose of medication to Day 28 (+/- 4 days) post-op/standard of care

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).

Outcome measures

Outcome measures
Measure	Oral Apixaban n=204 Participants 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.	Subcutaneous Enoxaparin n=196 Participants 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.
Number of Participants Who Met Medication Adherence Rates	173 Participants	164 Participants

SECONDARY outcome

Timeframe: On visit 4, which is 28 days (+/- 4 days) post-op/standard of care

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

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.

Outcome measures

Outcome measures
Measure	Oral Apixaban n=188 Participants 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.	Subcutaneous Enoxaparin n=187 Participants 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.
Number of Participants With a Patient Satisfaction Assessment Difficult remembering to take medication · Agree	23 Participants	23 Participants
Number of Participants With a Patient Satisfaction Assessment Difficult remembering to take medication · Neutral	16 Participants	15 Participants
Number of Participants With a Patient Satisfaction Assessment Difficult remembering to take medication · Disagree	149 Participants	149 Participants
Number of Participants With a Patient Satisfaction Assessment Pain associated with taking the medication · Agree	4 Participants	92 Participants
Number of Participants With a Patient Satisfaction Assessment Pain associated with taking the medication · Neutral	10 Participants	25 Participants
Number of Participants With a Patient Satisfaction Assessment Pain associated with taking the medication · Disagree	173 Participants	70 Participants
Number of Participants With a Patient Satisfaction Assessment Was medication easy to take · Agree	186 Participants	110 Participants
Number of Participants With a Patient Satisfaction Assessment Was medication easy to take · Neutral	2 Participants	21 Participants
Number of Participants With a Patient Satisfaction Assessment Was medication easy to take · Disagree	0 Participants	56 Participants

SECONDARY outcome

Timeframe: At baseline, and visit 4, which is 28 days (+/- 4 days) post-op/standard of care

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.

Outcome measures

Outcome measures
Measure	Oral Apixaban n=204 Participants 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.	Subcutaneous Enoxaparin n=196 Participants 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.
Change in Quality of Life From Baseline to 28 Days Post-op physical score-baseline	50.7 score on a scale Interval 19.2 to 64.5	49.7 score on a scale Interval 16.2 to 62.7
Change in Quality of Life From Baseline to 28 Days Post-op physical score-visit 4	39.2 score on a scale Interval 21.0 to 58.6	38.5 score on a scale Interval 17.8 to 60.7
Change in Quality of Life From Baseline to 28 Days Post-op Physical change	-5.9 score on a scale Interval -35.4 to 30.5	-6.2 score on a scale Interval -36.1 to 28.7
Change in Quality of Life From Baseline to 28 Days Post-op mental score-baseline	50.7 score on a scale Interval 19.2 to 64.5	49.7 score on a scale Interval 16.2 to 62.7
Change in Quality of Life From Baseline to 28 Days Post-op mental score-visit 4	50.7 score on a scale Interval 18.5 to 69.4	49.3 score on a scale Interval 19.7 to 62.2
Change in Quality of Life From Baseline to 28 Days Post-op Mental change	0.8 score on a scale Interval -30.3 to 30.8	0.0 score on a scale Interval -30.7 to 41.1

Adverse Events

Oral Apixaban

Serious events: 13 serious events

Other events: 53 other events

Deaths: 2 deaths

Subcutaneous Enoxaparin

Serious events: 14 serious events

Other events: 45 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Oral Apixaban n=204 participants at risk 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.	Subcutaneous Enoxaparin n=196 participants at risk 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.
Blood and lymphatic system disorders Hematoma	0.49% 1/204 • 90 (+/- 14) days post first study medication dose	2.6% 5/196 • 90 (+/- 14) days post first study medication dose
Surgical and medical procedures Wound infection	3.4% 7/204 • 90 (+/- 14) days post first study medication dose	5.1% 10/196 • 90 (+/- 14) days post first study medication dose
General disorders Dizziness	4.9% 10/204 • 90 (+/- 14) days post first study medication dose	0.51% 1/196 • 90 (+/- 14) days post first study medication dose
General disorders Suspected allergic reaction	0.49% 1/204 • 90 (+/- 14) days post first study medication dose	0.51% 1/196 • 90 (+/- 14) days post first study medication dose
General disorders Arthralgia	3.4% 7/204 • 90 (+/- 14) days post first study medication dose	1.0% 2/196 • 90 (+/- 14) days post first study medication dose
General disorders Bruising	2.0% 4/204 • 90 (+/- 14) days post first study medication dose	5.6% 11/196 • 90 (+/- 14) days post first study medication dose
General disorders Skin rash/cellulitis	0.49% 1/204 • 90 (+/- 14) days post first study medication dose	1.0% 2/196 • 90 (+/- 14) days post first study medication dose
General disorders Vaginal spotting/discharge/bleeding	2.0% 4/204 • 90 (+/- 14) days post first study medication dose	0.51% 1/196 • 90 (+/- 14) days post first study medication dose
General disorders Epistaxis	1.5% 3/204 • 90 (+/- 14) days post first study medication dose	1.0% 2/196 • 90 (+/- 14) days post first study medication dose
General disorders Abscess/discharge from incision	0.98% 2/204 • 90 (+/- 14) days post first study medication dose	0.00% 0/196 • 90 (+/- 14) days post first study medication dose
General disorders Headache	3.4% 7/204 • 90 (+/- 14) days post first study medication dose	2.6% 5/196 • 90 (+/- 14) days post first study medication dose
General disorders Hospitalized in 28 days	2.9% 6/204 • 90 (+/- 14) days post first study medication dose	2.6% 5/196 • 90 (+/- 14) days post first study medication dose

Additional Information

Dr. Saketh Guntupalli

University of Colorado, Anschutz Medical Campus

Phone: 303-724-2033

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Oral Apixaban n=204 participants at risk 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.	Subcutaneous Enoxaparin n=196 participants at risk 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.
Gastrointestinal disorders Admitted for abdominal pain and emesis	0.00% 0/204 • 90 (+/- 14) days post first study medication dose	0.51% 1/196 • 90 (+/- 14) days post first study medication dose
Surgical and medical procedures Admitted for ileus	0.49% 1/204 • 90 (+/- 14) days post first study medication dose	0.00% 0/196 • 90 (+/- 14) days post first study medication dose
Surgical and medical procedures Admitted for wound Infection	0.49% 1/204 • 90 (+/- 14) days post first study medication dose	1.5% 3/196 • 90 (+/- 14) days post first study medication dose
General disorders Admitted for neutropenic fever from chemotherapy	0.49% 1/204 • 90 (+/- 14) days post first study medication dose	0.51% 1/196 • 90 (+/- 14) days post first study medication dose
General disorders Admitted for pneumonia	0.00% 0/204 • 90 (+/- 14) days post first study medication dose	1.0% 2/196 • 90 (+/- 14) days post first study medication dose
General disorders Admitted for excess kidney fluid and stent placement	0.00% 0/204 • 90 (+/- 14) days post first study medication dose	0.51% 1/196 • 90 (+/- 14) days post first study medication dose
General disorders Admitted for Nausea/emesis from chemotherapy	1.5% 3/204 • 90 (+/- 14) days post first study medication dose	0.00% 0/196 • 90 (+/- 14) days post first study medication dose
General disorders Admitted for dehydration	0.98% 2/204 • 90 (+/- 14) days post first study medication dose	1.0% 2/196 • 90 (+/- 14) days post first study medication dose
Gastrointestinal disorders Admitted for clostridium difficile	0.00% 0/204 • 90 (+/- 14) days post first study medication dose	0.51% 1/196 • 90 (+/- 14) days post first study medication dose
General disorders Admitted for small bowel obstruction	0.49% 1/204 • 90 (+/- 14) days post first study medication dose	1.0% 2/196 • 90 (+/- 14) days post first study medication dose
General disorders Admitted for pelvic infection	0.49% 1/204 • 90 (+/- 14) days post first study medication dose	0.00% 0/196 • 90 (+/- 14) days post first study medication dose
General disorders Admitted for wound closure	0.00% 0/204 • 90 (+/- 14) days post first study medication dose	0.51% 1/196 • 90 (+/- 14) days post first study medication dose
Surgical and medical procedures Admitted for vaginal cuff bleeding from open vessel from surgery stitches	0.49% 1/204 • 90 (+/- 14) days post first study medication dose	0.00% 0/196 • 90 (+/- 14) days post first study medication dose
General disorders Admitted for nausea and stomach flu	0.49% 1/204 • 90 (+/- 14) days post first study medication dose	0.00% 0/196 • 90 (+/- 14) days post first study medication dose
General disorders Admitted for ongoing UTI/sepsis - resolved	0.49% 1/204 • 90 (+/- 14) days post first study medication dose	0.00% 0/196 • 90 (+/- 14) days post first study medication dose