select-d: Anticoagulation Therapy in SELECTeD Cancer Patients at Risk of Recurrence of Venous Thromboembolism - select-d

niversity of Warwick0 个研究点目标入组 530 人开始时间: 2013年2月18日最近更新: 2013年3月18日

试验速览

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•1. Patients with active cancer. 2. Patients with a primary presentation of an objectively confirmed VTE - symptomatic DVT or symptomatic or incidental PE. 3. ECOG Performance Status is 0, 1 or 2. 4. Age 18 years or over and written informed consent given. 5. Adequate haematological function (recommended levels – haemoglobin (Hb) > 10g/dl, white cell count (WCC) > 2x109/l, platelets > 100 x109/l). 6. Adequate hepatic and renal function – liver enzymes < x3 upper limit of normal (ULN) creatinine clearance > 30 ml per minute.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 400
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 130

•1. Patients taking any anticoagulants. 2. Patients on more than 75 mg aspirin per day. 3. More than 72 hours pre-treatment with anticoagulant for this episode. 4. Clinically significant liver disease (e.g. acute hepatitis, chronic active hepatitis, or cirrhosis) or an alanine aminotransferase level that is equal to or greater than 3 times ULN range. 5. Bacterial endocarditis. 6. Active bleeding or a high risk of bleeding, contraindicating anticoagulant treatment. 7. Systolic blood pressure greater than 180 mm Hg or Diastolic blood pressure greater than 110 mm Hg. 8. Of childbearing potential (both male and female participants) without a combination of proper contraceptive measures. 9. Pregnant or breast-feeding. 10. Concomitant use of strong cytochrome P-450 3A4 inhibitors (e.g. human immunodeficiency virus protease inhibitors or systemic ketoconazole) or inducers (e.g. rifampicin, carbamazepine, or phenytoin) and p-glycoprotein inhibitors/ inducers.

发起方

niversity of Warwick