EUCTR2018-001735-49-GB进行中（未招募）1 期
Rivaroxaban versus warfarin for stroke patients with antiphospholipid syndrome, with or without SLE (RISAPS): a randomised, controlled, open-label, phase II/III, non-inferiority trial - RIvaroxaban for Stroke patients with AntiPhospholipid Syndrome
niversity College London0 个研究点目标入组 140 人开始时间: 2019年1月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion criteria
- •1. Patients must be confirmed as having persistent antiphospholipid antibodies (aPL), defined as: positivity of one or more aPL, i.e. lupus anticoagulant, IgG and/or IgM anticardiolipin and/or anti beta 2 glycoprotein I antibodies at >40 GPL or MPL units or > the 99th centile of normal, on at least two consecutive occasions at least 12 weeks apart.
- •2. One or more of: a) Ischaemic stroke; b) transient ischaemic attack (TIA) with evidence of either acute or chronic ischaemic injury on brain MRI (including diffusion weighted imaging (DWI) lesion(s), previous cortical or subcortical infarction(s), or white matter hyperintensities) and diagnosed by a clinician with expertise in stroke; c) brain infarcts (territorial or subcortical) or white matter hyperintensities (WMH) of presumed vascular origin on brain MRI, with or without cognitive impairment; and an expert clinical opinion that anticoagulation is a reasonable treatment option (with the aim of preventing ischaemic brain injury).
- •3. Women must be on adequate contraception, barrier or hormonal, unless postmenopausal or sterilised.
- •NB: patients weighing <50kg or >120kg may be included in RISAPS on a case by case basis, following assessment by the Investigator (PI) and consultation with the Chief Investigator (CI)/delegate before enrolment.
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Exclusion Criteria
- •1. Pregnant or lactating women
- •2. Severe renal impairment with creatinine clearance <30 mL/min (i.e. 29 mL/min or less)
- •3. Liver function tests ALT > 3 x ULN
- •4. Cirrhotic patients with Child Pugh B or C
- •5. Thrombocytopenia (platelets < 75 x 109/L)
- •6. Non-adherence on warfarin (based on clinical assessment)
- •7. Patients taking strong inhibitors of both CYP3A4 and P-gp pathways such as
- •a. Systemic azole antifungals (e.g. ketoconazole, itraconazole, voriconazole, posaconazole)
- •b. Patients on HIV protease inhibitors (e.g. ritonavir)
- •8. Patients on strong CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital or St. John's Wort)
- •9. Patients on dronedarone
- •10. Patients less than 18 years of age
- •11. Refusal to consent to the site informing GP and healthcare professional responsible for anticoagulation care, of participation
- •12. Contraindications to MRI (e.g. cardiac pacemaker, severe claustrophobia, inability to lie flat: patients who do not meet local safety rules for MRI).
- •13. Patients at high risk of bleeding and not suitable for anticoagulation therapy.
- •14. Previous known allergy or intolerance to warfarin or rivaroxaban.
- •15. Patients with known galactose intolerance, total lactase deficiency or galactose malabsorption.
研究者
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