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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Number of Participants With Incidence of Clinically Relevant Non Major Bleeding Events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Oral apixaban
Oral apixaban 2.5 mg tablet twice daily for 28 days post-surgery
干预措施: Oral apixaban (Drug)
Subcutaneous enoxaparin
Subcutaneous enoxaparin 40mg once daily (QD) for 28 days post-surgery.
干预措施: Subcutaneous enoxaparin (Drug)
结局指标
主要结局
Number of Participants With Incidence of Clinically Relevant Non Major Bleeding Events
时间窗: 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.
Number of Participants With Incidence of Major Bleeding
时间窗: Day 1 post-op/standard of care first medication dose to day 90 (+/-14 days) post-op/standard of care
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.
次要结局
- Number of Participants Who Met Medication Adherence Rates(Day 1 post-op/standard of care first dose of medication to Day 28 (+/- 4 days) post-op/standard of care)
- Number of Participants With a Patient Satisfaction Assessment(On visit 4, which is 28 days (+/- 4 days) post-op/standard of care)
- Change in Quality of Life From Baseline to 28 Days Post-op(At baseline, and visit 4, which is 28 days (+/- 4 days) post-op/standard of care)
- Number of Participants With Incidence of Venous Thromboembolism (VTEs): Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)(Day 1 post-op/standard of care to day first dose of medication 90 (+/- 14 days) post-op/standard of care)