KCT0004697招募中未知
A prospective, multicenter, open-label, observation study evaluating the efficacy and safety of edoxaban in patients with cancer-associated venous thromboembolism
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational Study
入排标准
- 年龄范围
- 20(Year) 至 99(Year)（—）
- 性别
- All
入选标准
- •(1) Patients = 20 years old and active cancer. *Active cancer is defined as a histologically confirmed solid cancer or hematologic malignancy (except for basal cell or squamous cell carcinoma of the skin), which were diagnosed or treated within the prior 6 months, or as a recurrent/metastatic cancer.
- •(2) Newly diagnosed, objectively confirmed, symptomatic or incidentally detected proximal lower extremity DVT (I.e., popliteal, femoral, iliac or inferior vena cava vein thrombosis), symptomatic PE, or incidental PE of a segmental or larger pulmonary artery.
- •(3) Life expectancy > 3 months and an intention of anticoagulation for at least 3 months.
- •(4) Provide written informed consent.
排除标准
- •(1) Unresected gastric carcinoma or esophageal carcinoma;
- •(2) Isolated asymptomatic distal DVT, isolated asymptomatic subsegmental PE, or isolated splanchnic vein thrombosis;
- •(3) History of total gastrectomy;
- •(4) therapeutic anticoagulation for > 96 hours prior to enrolment to treat current episode of qualifying VTE;
- •(5) History of recent major or clinically relevant bleeding within the previous 4 weeks;
- •(6) Hemodynamically unstable PE, indicating systolic blood pressure < 90mmHg at the time of study entry;
- •(7) ECOG performance status score of 3 or 4;
- •(8) Overt brain metastasis. Patients who have controlled brain metastasis with a need of prednisone =10mg or equivalent are eligible;
- •(9) Conditions associated with a high risk of serious bleeding as judged by the investigator (eg, active peptic ulcer or recent neurosurgery), or other serious illness or medical conditions (myocardial infarction within 3 months prior to study entry, active uncontrolled, significant neurologic or psychiatric diseases including dementia or seizure) as judged by the investigator;
- •(10) Inadequate renal function (calculated creatinine clearance < 30 mL/min) or inadequate hepatic function [alanine aminotransferase > 3 times the upper limit of normal (ULN) (if liver metastasis, alanine aminotransferase > 5 times the ULN) or total bilirubin > 2 times the ULN (if liver metastasis, total bilirubin > 3 times the ULN)];
- •(11) Treatment of qualifying VTE with thrombectomy, insertion of a caval filter, or thrombolysis; (12) Platelet count < 50,000/mL at the time of study entry;
- •(13) Treatment with aspirin in a dosage of >100 mg/day, clopedogrel > 75 mg/day, or dual antiplatelet therapy (any 2 antiplatelet agents including aspirin plus any other oral or intravenous antiplatelet drug) anticipated to continue during the study;
- •(14) Concurrent systemic use of strong CYP3A4 inducers (i.e., rifampin, phemobarbital) or strong CYP3A4 inhibitoers (i.e., HIV protease inhibitors, systemic ketoconazole) anticipated to continue during the study;
- •(15) Women of childbearing potential who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for the entire study period, who are using a prohibited contraceptive method, or who are pregnant or breastfeeding;
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