ISRCTN86712308已完成3 期
SELECT-D: Anticoagulation therapy in SELECTeD cancer patients at risk of recurrence of venous thromboembolism: a prospective, randomised, open label, multicentre pilot study
niversity of Warwick (UK)0 个研究点目标入组 530 人开始时间: 2013年4月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 530
研究概览
简要总结
2018 interim results in https://www.ncbi.nlm.nih.gov/pubmed/29746227 2020 results in https://www.ncbi.nlm.nih.gov/pubmed/31995662 (added 30/01/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients with active cancer.
- •2. Patients with a primary presentation of an objectively confirmed venous thromboembolism (VTE) symptomatic deep venous thrombosis (DVT) or symptomatic or incidental pulmonary embolism (PE).
- •3. Eastern Cooperative Oncology Group (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) > 2x10(9)/l, platelets > 100 x10(9)/l).
- •6. Adequate hepatic and renal function ? liver enzymes < x3 upper limit of normal (ULN) creatinine clearance > 30 ml per minute
排除标准
- •Current exclusion criteria as of 31/08/2018:
- •1. Primary oesophageal or gastro-oesophageal cancer
- •2. Patients taking any anticoagulants.
- •3. Patients on more than 75 mg aspirin per day.
- •4. More than 72 hours pre-treatment with anticoagulant for this episode.
- •5. 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.
- •6. Bacterial endocarditis.
- •7. Active bleeding or a high risk of bleeding, contraindicating anticoagulant treatment.
- •8. Systolic blood pressure greater than 180 mm Hg or Diastolic blood pressure greater than 110 mm Hg.
- •9. Of childbearing potential (both male and female participants) without a combination of proper contraceptive measures.
- •10. Pregnant or breastfeeding.
- •11. 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.
- •Previous exclusion criteria:
- •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 breastfeeding.
- •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.
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