Oral Apixaban (Eliquis) Versus Enoxaparin (Lovenox) for Thromboprophylaxis in Women With Suspected Pelvic Malignancy
Condition: Gynecologic Cancer; Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Intervention: Oral apixaban; Subcutaneous enoxaparin
Intervention description: 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.; 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.
Intervention MeSH terms: Enoxaparin; Apixaban
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 400.0
Sex: Female
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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