MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention: The MOSES-study. An International, Multicentre, Randomised-controlled, Two-arm, Assessor-blinded Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 620
- 试验地点
- 14
- 主要终点
- Recurrent stroke of any type
研究概览
简要总结
The present trial is addressing the question if a biologically distinct subgroup of ischemic stroke patients without known atrial fibrillation at admission, selected by a cut-off level of MRproANP concentration, which represents a underlying increased risk of cardiac thrombogenicity, benefits from direct oral anticoagulation (DOAC) within 7 days of symptom onset versus standard of care (antiplatelet) as preventive treatment.
详细描述
Three DOACs with marketing authorisation in Switzerland and the EU for the prevention of stroke and systemic embolism in patients with atrial fibrillation can be used. Eligible patients will be randomly assigned to either the standard of care (control) or the experimental (direct start with DOAC) arm with a ratio of 1:1. Each study participant will be observed during a follow up period within one year after index stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Blinded endpoint assessment by independent CEC
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of ischemic stroke
- •level ≥200pmol/L within 72 hours from symptom onset
- •Age ≥ 18 years
- •Signed informed consent
排除标准
- •History of AF, AF on 12-lead ECG on admission or any AF ≥30 seconds during heart-rhythm monitoring prior to randomization
- •Other condition that require anticoagulant therapy (e.g., venous thromboembolism) as per Investigator's judgment including therapeutical dose of low-molecular-weight heparin or heparin
- •Strong likelihood to be treated with prolonged (i.e. more than 30 days) dual antiplatelet therapy during the course of the trial (such as coronary stenting, etc.)
- •Patients undergoing planned procedures where therapy with a DOAC is a contraindication (e.g. surgery)
- •Previous intracranial hemorrhage in the last year
- •Evidence of severe cerebral amyloid angiopathy if MRI scan performed
- •Chronic kidney disease with creatinin clearance <30ml/min and or subject who requires haemodialysis or peritoneal dialysis
- •Known bleeding diathesis (e.g. active peptic ulcer disease , platelet count < 100'000/mm3 or haemoglobin < 9 g/dl or INR ≥ 1.7, documented haemorrhagic tendencies or blood dyscrasias)
- •Active infective endocarditis
- •CT or MRI evidence of cerebral vasculitis
- •Known allergy or intolerance to antiplatelets or DOACs
- •Female who is pregnant or lactating or has a positive pregnancy test at time of admission
- •Current participation in another drug trial
研究组 & 干预措施
DOACs
Direct oral anticoagulants
干预措施: Dabigatran (Drug)
DOACs
Direct oral anticoagulants
干预措施: Apixaban (Drug)
DOACs
Direct oral anticoagulants
干预措施: Edoxaban (Drug)
Antiplatelets
SOC therapy with antiplatelets until study completion or until detection of AF. After detection of AF treatment with DOAC becomes SOC.
干预措施: Aspirin (Drug)
Antiplatelets
SOC therapy with antiplatelets until study completion or until detection of AF. After detection of AF treatment with DOAC becomes SOC.
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Recurrent stroke of any type
时间窗: within one year after index stroke
The primary outcome measure is the time to any recurrent stroke (ischemic, hemorrhagic, unspecified, or fatal stroke)
次要结局
- Composite of major bleeding, recurrent stroke and/or vascular death(within one year after index stroke)
- Major bleeding, recurrent stroke and/or vascular death as single components(within one year after index stroke)
研究者
Mira Katan
Prof. Dr. med.
University of Zurich