ISRCTN10280992进行中（未招募）2 期
Rivaroxaban versus warfarin for stroke patients with antiphospholipid syndrome, with or without SLE (RISAPS): a randomised, controlled, open-label, phase IIb, non-inferiority proof of principle trial
niversity College London0 个研究点目标入组 43 人开始时间: 2019年4月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 43
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 28/11/2022:
- •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 two or more 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 magnetic resonance imaging (MRI) (including diffusion-weighted magnetic resonance 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. Patients must weigh = 50kg and = 135kg
- •4. Women must be on adequate contraception, barrier or hormonal, unless postmenopausal or sterilised
- •Previous inclusion criteria as of 19/07/2021:
- •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 antibeta 2 glycoprotein I antibodies at > 40 GPL or MPL units or > the 99th centile of normal, on two or more 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 magnetic resonance 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.
- •Previous 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. Criteria for the laboratory diagnosis of aPL are detailed in Appendix 3 of the Protocol.
- •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 DWI lesion(s), previous cortical or subcortical infarction(s), or white matter hyperintensities (WMH)) and diagnosed by a clinician with expertise in stroke; c) brain infarcts (territorial or subcortical) or 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 hormo
排除标准
- •Current exclusion criteria as of 28/11/2022:
- •1. Patients who are triple positive for antiphospholipid antibodies (presence of lupus anticoagulant, IgG and/or IgM anticardiolipin and anti beta 2 glycoprotein I antibodies at >40 GPL or MPL units or > the 99th centile of normal*. (*patients who have previously been triple aPL-positive and have single or double aPL positivity on at least 2 occasions over at least 6 months, including once within 1 month prior to randomisation, can be recruited to the trial)
- •2. Pregnant or lactating women
- •3. Severe renal impairment with creatinine clearance < 30 mL/min (i.e. 29 mL/min or less)
- •4. Liver function tests ALT > 3 x ULN
- •5. Cirrhotic patients with Child Pugh B or C
- •6. Thrombocytopenia (platelets < 75 x 109/L)
- •7. Non-adherence on warfarin (based on clinical assessment)
- •8. Patients taking strong inhibitors of both CYP3A4 and P-gp pathways such as
- •8.1. Systemic azole antifungals (e.g. ketoconazole, itraconazole, voriconazole, posaconazole)
- •8.2. Patients on human immunodeficiency virus (HIV) protease inhibitors (e.g. ritonavir)
- •9. Patients on strong CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine,
- •phenobarbital or St. John's Wort)
- •10. Patients on dronedarone
- •11. Patients on levetiracetam, sodium valproate/valproic acid, oxcarbazepine or topiramate
- •12. Patients less than 18 years of age
- •13. Refusal to consent to the site informing General Practitioner (GP) and Healthcare
- •Professional responsible for anticoagulation care of the participant.
- •14. Contraindications to MRI (e.g. cardiac pacemaker, severe claustrophobia, inability to lie
- •flat: patients who do not meet local safety rules for MRI).
- •15. Patients at high risk of bleeding and not suitable for anticoagulation therapy.
- •16. Previous known allergy or intolerance to warfarin or rivaroxaban.
- •17. Women planning to become pregnant within the 2-year follow-up period.
- •18. Patients with known galactose intolerance, total lactase deficiency or galactose
- •malabsorption.
- •19. Patients who have had active cancer (excluding non-melanoma skin cancers) within the
- •last 2 years
- •20. Any other reason that the PI or delegate considers would make the patient unsuitable to
- •enter RISAPS
- •Previous exclusion criteria as of 19/07/2021:
- •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 10^9/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 human immunodeficiency virus (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 General Practitioner and Healthcare Professional responsible for anticoagulation care of the participant
- •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. Women planning to become pre
研究者
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