Venous Thromboembolism Clinical Trial
Official title:
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 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.
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