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

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 2

Conditions: Venous Thromboembolism; Gynecologic Cancer

Treatments: Drug: Oral apixaban; Drug: Subcutaneous enoxaparin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02366871

15-0187.cc

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 400 patients

Sex: Female

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Suitable candidate for surgery (meets appropriate performance status, no significant cardiac/renal/hepatic dysfunction
• Diagnosis of pelvic malignancy (suspected/confirmed ovarian, endometrial/uterine, cervical cancers, and vulvar cancers) undergoing surgical debulking,
• Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to surgery,
• Women must not be breastfeeding, WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) apixaban plus 5 half-lives of study drug apixaban (2.5 days) plus 30 days (duration of ovulatory cycle) for a total of 32.5 days post-treatment completion.

Exclusion criteria

• Malignancy or mass that is non-gynecologic in origin (mass/tumor of origin other than reproductive organ such as rectal, abdominal, breast)
• Positive pregnancy test on day of surgery,
• Known history of Venous (Thromboembolism) VTE prior to diagnosis (DVT or Pulmonary Embolism (PE)) due to increased underlying risk of new event
• Concomitant NSAIDS or other anticoagulant/antiplatelet therapy including Acetylsalicylic Acid (Aspirin) (ASA) >81mg/day,
• Selective serotonin re uptake inhibitor (SSRIs) and Serotonin-nor-epinephrine re uptake inhibitor (SNRIs) (common anti-depressant therapies),
• Uncontrolled severe hypertension (systolic >200 mmHg or diastolic >120 mmHg),
• With prosthetic heart valves,
• Active bleeding condition (not limited to: thrombocytopenia, haemophilias, potential bleeding lesions, recent trauma or surgery, recent stroke, confirmed intracranial or intraspinal bleeding),
• Known or documented bleeding disorders not limited to: anti-phospholipid syndrome, homozygotes for Factor V Leiden deficiency, antithrombin III deficiency, protein C deficiency, Protein S deficiency, hyperhomocysteinemia, systemic lupus erythematous, or Prothrombin G2020 gene mutation,
• Significant renal disease as defined by creatinine clearance less than 30 mL/min,
• Significant liver disease as defined as Aspartate Transaminase (AST) or Alanine Transaminase (ALT) twice than normal,
• Concomitant use of dual strong inhibitors or inducers (CYP3A4, P-gp)
• Protein C deficiency (increased risk of skin necrosis do those on injectable anticoagulation),
• Documented allergy to apixaban and/or enoxaparin,
• Patient's deemed otherwise clinically unfit for clinical trial per Investigator's discretion

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Oral apixaban

Experimental group

Description:

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

Treatment:

Drug: Oral apixaban

Subcutaneous enoxaparin

Active Comparator group

Description:

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

Treatment:

Drug: Subcutaneous enoxaparin