NCT02238470

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	oral anticoagulants	Comparison of patients receiving oral anticoagulants with or without microbleeds in magnetic resonance imaging

Timeline

• Start date: 2012-04-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2014-09-12
• Last updated: 2018-08-03

Locations

30 sites across 2 countries: Italy, Spain