CTRI/2024/06/068730尚未招募3 期
Apixaban in Prevention of VenousThromboembolism in Advanced EpithelialOvarian Cancer Receiving NeoadjuvantChemotherapy: A Randomized ControlledOpen-Label Clinical Trial - NI
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1) All women histologically diagnosed with
- •advanced stage ovarian cancer (FIGO Stage
- •III/IV) triaged to receive neoadjuvant
- •chemotherapy
- •2) = 18 years age
- •3) ECOG performance status 0-3
- •4) Adequate renal function: Serum Creatinine
- •levels 0.5 to 1.1 mg/dL
- •5) Khorana score =2
- •6) Be able to provide informed consent and sign
- •an informed consent document
排除标准
- •1. Previously diagnosed/treated VTE
- •2. Evidence of VTE on screening duplex
- •compression ultrasonography or incidental
- •VTE identified on CT scans ordered
- •primarily for staging of malignancy prior to
- •randomization
- •3. History of malignancies of other than ovarian
- •4. Known brain metastases
- •5. Bleeding diathesis, hemorrhagic lesions, hemorrhagic cerebrovascular accident, active bleeding, and other conditions with a
- •high risk for bleeding
- •6. Diagnosed significant liver disease or
- •dysfunction, as defined by liver function test
- •(LFT) abnormalities
- •7. PLatelet count less than 100,000/mm3
- •8. Deranged kidney function
- •Concomitant use of anticoagulation therapy
- •for prior VTE or other indications with
- •either LMWH, warfarin, or direct oral anti- anticoagulants
- •9. Dual anti-platelet therapy, daily non- steroidal anti-inflammatory drugs, or other
- •medications known to increase the risk of
- •bleeding (a daily dose of =100 mg of aspirin
- •and single agent clopidogrel are allowed)
- •10. Known allergies, hypersensitivity, or
- •intolerance to Apixaban or its excipients
- •11. Pregnant or breast-feeding women
研究者
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