A prospective randomised controlled phase II/III clinical trial of rivaroxaban versus warfarin in patients with thrombotic antiphospholipid syndrome, with or without SLE. - Rivaroxaban in Antiphospholipid Syndrome (RAPS)

niversity College London0 个研究点目标入组 116 人开始时间: 2012年10月8日最近更新: 2019年4月30日

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•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
•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 148
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 8

•1) Previous arterial thrombotic events due to APS 2) Recurrent venous thromboembolic events whilst on warfarin 3) Pregnant or lactating women 4) Severe renal impairment (creatinine clearance (calculated using the Cockcroft & Gault Equation Appendix A) < 30 mL/min (i.e. 29 mL/min or less)) 5) Liver function tests (ALT > 2 x ULN) 6) Thrombocytopenia (platelets < 75 x 10^9/L) 7) Non-compliance on warfarin (based on clinical assessment) 8) Patients on azole antifungals (e.g. ketoconazole, itraconazole, voriconazole and posaconazole) 9) Patents on Human Immunodeficiency Virus (HIV) protease inhibitors (e.g. ritonavir) 10) Patients on strong CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine or phenobarbital) 11) Patients less than 18 years of age

发起方

niversity College London