KCT0004697
Recruiting
未知
A prospective, multicenter, open-label, observation study evaluating the efficacy and safety of edoxaban in patients with cancer-associated venous thromboembolism
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Yonsei University Health System, Severance Hospital
- Enrollment
- 300
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(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.
Exclusion Criteria
- •(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)];
Outcomes
Primary Outcomes
Not specified
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