Intracerebral Hemorrhage Due to Oral Anticoagulants: Prediction of the Risk by Magnetic Resonance

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: oral anticoagulants


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Dementia 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oral anticoagulants<br>Patients who will receive oral anticoagulants indefinitely for the secondary prevention of cardioembolic stroke | Drug: oral anticoagulants<br>* Comparison of patients receiving oral anticoagulants with or without microbleeds in magnetic resonance imaging<br>* Other names: apixaban;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracranial Hemorrhage | Telephone interview every 3 months, starting 3 months after ischemic stroke (3, 6, 9, 12, 15, 18, 21 and 24 months) | every 3 months after stroke, until 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemic stroke |  | within 24 months after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic stroke, Intracerebral hemorrhage, Subdural hemorrhage, Microbleed, Leukoaraiosis, Oral anticoagulants