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临床试验/NCT02238470
NCT02238470已完成不适用

Intracerebral Hemorrhage Due to Oral Anticoagulants in the Secondary Prevention of Ischemic Stroke: Prediction of the Risk by the Detection of Leukoaraiosis and Microbleeding With Magnetic Resonance

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau30 个研究点 分布在 2 个国家目标入组 1,000 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,000
试验地点
30
主要终点
Intracranial Hemorrhage

研究概览

简要总结

The purpose of this study is to determine whether Magnetic Resonance Imaging may predict the risk of Intracerebral Hemorrhage for patients with ischemic stroke who receive indefinite oral anticoagulation

详细描述

OBJECTIVES. To evaluate whether Magnetic Resonance (MR) helps in predicting the risk of Intracranial Hemorrhage (ICH-OA) in patients with ischemic stroke who will receive Oral Anticoagulants (OA) for the secondary prevention of stroke. By allowing the detection and quantification of leukoaraiosis and microbleeding, MR aids in the assessment of hypertensive and/or amyloid angiopathy, two findings that may increase the risk of ICH-OA. The study of these and other known variables associated with the risk of ICH-OA will improve the selection of patients to be treated with OA. METHODOLOGY. A prospective, observational, multicentric study of 1000 patients with stroke, older than 65 y, candidates to receive OA indefinitely. The primary end-point is ICH-OA. A MR will be performed before starting the treatment, in which we will evaluate the presence and degree of leukoaraiosis (Fazekas's scale) and microbleeding (BOMBS scale). A visit will be scheduled at the first month after inclusion, and thereafter the patient will be followed-up during 2 years with phone interviews, to evaluate the appearance of the primary end-point. We will register data about demographics, vascular risk factors, anticoagulation, MR, echocardiography and co-morbidity. With those variables associated with ICH-OA in the univariate analyses, a regression analysis will be performed, in which ICH-OA will be the dependent variable. Finally, each independent predictive variable will receive a score to elaborate a predictive model of ICH-OA.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 65 y
  • TIA or ischemic stroke
  • The patient will receive indefinitely treatment with oral anticoagulants for the secondary prevention of cardioembolic stroke
  • No previous treatment with oral anticoagulants
  • Signed consent before performing a Magnetic Resonance
  • Long-term follow-up will be possible

排除标准

  • The patient will receive oral anticoagulation as a primary prevention treatment
  • The etiology that motivates the onset of oral anticoagulants is not cardioembolism
  • Absolute contraindication to receive oral anticoagulants
  • Arterial hypertension that is not controlled, hypertensive crisis
  • Live-expectancy less than 1 year
  • Any social or psychological reason that prevents follow-up
  • Contraindication to perform a Magnetic Resonance examination
  • Patients who received oral antiacoagulants prior to the current stroke
  • The Magnetic Resonance imaging was performed more than 1 month after the onset of treatment with oral anticoagulants

研究组 & 干预措施

Oral anticoagulants

Patients who will receive oral anticoagulants indefinitely for the secondary prevention of cardioembolic stroke

干预措施: oral anticoagulants (Drug)

结局指标

主要结局

Intracranial Hemorrhage

时间窗: every 3 months after stroke, until 24 months

Telephone interview every 3 months, starting 3 months after ischemic stroke (3, 6, 9, 12, 15, 18, 21 and 24 months)

次要结局

  • Ischemic stroke(within 24 months after inclusion)

研究者

发起方
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
申办方类型
Other
责任方
Sponsor

研究点 (30)

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