2024-517600-11-01招募中3 期
MidregiOnal proatrial natriuretic peptide to guide SEcondary Stroke prevention: The MOSES-study. An international, multicentre, randomised-controlled, two-arm, assessor-blinded trial.
University Hospital Zurich4 个研究点 分布在 2 个国家目标入组 190 人开始时间: 2025年1月17日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 190
- 试验地点
- 4
- 主要终点
- The primary outcome measure is the time to any recurrent stroke within 1 year after the index ischemic stroke.
研究概览
简要总结
The overall objective of this study is to demonstrate that the efficacy of DOACs is superior to the standard of care (SOC, i.e. treatment with antiplatelets until study end or until AF is detected) for the prevention of stroke recurrence in MR-proANP selected acute ischemic stroke patients without known AF on admission.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •MR-proANP level ≥200pmol/L within 72 hours from symptom onset, Age ≥ 18 years, Clinical diagnosis of ischemic stroke, Written informed consent according to country specific details
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 therapeutic dose of low-molecularweight heparin or heparin; Strong likelihood to be treated with prolonged (i.e. more than 90 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. acute surgery); Previous intracranial symptomatic hemorrhage in the last 24 months; Evidence of severe cerebral amyloid angiopathy if MRI scan performed; Chronic kidney disease with creatinine 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 < 8 g/dl or INR ≥ 1.7, documented haemorrhagic tendencies or blood dyscrasias); Active infective endocarditis; Known allergy or intolerance to antiplatelets or DOACs; Female who is pregnant or lactating or has a positive pregnancy test at time of admission; If restricted by national law: Current participation in another drug trial
结局指标
主要结局
The primary outcome measure is the time to any recurrent stroke within 1 year after the index ischemic stroke.
The primary outcome measure is the time to any recurrent stroke within 1 year after the index ischemic stroke.
次要结局
- Composite of major bleeding, recurrent stroke and/or vascular death (whichever occurs first) within 1 year after the index ischemic stroke; single components of the composite outcome above
研究者
Mira Katan
Scientific
University Hospital Zurich
研究点 (4)
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