ISRCTN68222801已完成2 期
A prospective randomised controlled phase II/III clinical trial of rivaroxaban versus warfarin in patients with thrombotic antiphospholipid syndrome, with or without systemic lupus erythematosus
niversity College London (UK)0 个研究点目标入组 156 人开始时间: 2012年10月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 156
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
- 性别
- All
入选标准
- •Current inclusion criteria as of 02/10/2013:
- •1. Patients with thrombotic APS, with or without SLE, who have had either a single episode of VTE whilst not on anticoagulation or recurrent episode(s) which occurred whilst off anticoagulation or on sub-therapeutic anticoagulant therapy
- •2. Patients with a target INR of 2.5 (range 2.0-3.0)
- •3. Treated with warfarin for a minimum period of three months since last VTE
- •4. Female patients must be using adequate contraception with the exception of postmenopausal or sterilised women
- •Previous inclusion criteria:
- •1. Patients with thrombotic APS, with or without SLE, who have had either a single episode of VTE whilst not on anticoagulation or recurrent episode(s) which occurred whilst off anticoagulation or on sub-therapeutic anticoagulant therapy.
- •2. Patients with a target INR of 2.5 (range 2.0-3.0)
- •3. Treated with warfarin for a minimum period of six months since last VTE
- •4. Female patients must be using adequate contraception with exception to postmenopausal or sterilised women
排除标准
- •Current exclusion criteria as of 02/10/2013:
- •1. Previous arterial thrombotic events due to APS
- •2. Recurrent venous thromboembolic events whilst on warfarin at a therapeutic INR of 2.0-3.0
- •3. Pregnant or lactating women
- •4. Severe renal impairment (creatinine clearance [calculated using the Cockcroft & Gault formula Appendix A] < 30 mL/min (i.e. 29 mL/min or less)
- •5. Liver function tests ALT > 2 x ULN
- •6. Cirrhotic patients with Child Pugh B or C
- •7. Thrombocytopenia (platelets < 75 x 10^9/L)
- •8. Non-compliance on warfarin (based on clinical assessment)
- •9. Patients on azole antifungals (e.g. ketoconazole, itraconazole, voriconazole and posaconazole)
- •10. Patients on Human Immunodeficiency Virus (HIV) protease inhibitors (e.g. ritonavir)
- •11. Patients on strong CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital or St John's Wort)
- •12. Patients less than 18 years of age
- •13. Refusal to consent to the site informing GP and healthcare professional responsible for anticoagulation care, of participation
- •Previous exclusion criteria:
- •1. Previous arterial thrombotic events due to APS
- •2. Recurrent venous thromboembolic events whilst on warfarin at a therapeutic INR of 2.0-3.0
- •3. Pregnant or lactating women
- •4. Severe renal impairment (creatinine clearance [calculated using the Cockcroft & Gault formula Appendix A of the protocol] < 30 mL/min (i.e. 29 mL/min or less)
- •5. Liver function tests ALT > 2 x ULN
- •6. Cirrhotic patients with Child Pugh B or C
- •7. Thrombocytopenia (platelets < 75 x 10^9/L)
- •8. Non-compliance on warfarin (based on clinical assessment)
- •9. Patients on azole antifungals (e.g. ketoconazole, itraconazole, voriconazole and posaconazole)
- •10. Patents on Human Immunodeficiency Virus (HIV) protease inhibitors (e.g. ritonavir)
- •11. Patients on strong CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine or phenobarbital)
- •12. Patients less than 18 years of age
- •13. Refusal to consent to CTU informing GP of participation
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