This trial is active, not recruiting.

Condition ischemic stroke
Treatment oral anticoagulants
Sponsor Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Start date April 2012
End date September 2017
Trial size 1000 participants
Trial identifier NCT02238470, IIBSP-ACO-2010-10, PI11/00296


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Patients who will receive oral anticoagulants indefinitely for the secondary prevention of cardioembolic stroke
oral anticoagulants warfarin
Comparison of patients receiving oral anticoagulants with or without microbleeds in magnetic resonance imaging

Primary Outcomes

Intracranial Hemorrhage
time frame: every 3 months after stroke, until 24 months

Secondary Outcomes

Ischemic stroke
time frame: within 24 months after inclusion

Eligibility Criteria

Male or female participants at least 65 years old.

Inclusion Criteria: 1. Age > 65 y 2. TIA or ischemic stroke 3. The patient will receive indefinitely treatment with oral anticoagulants for the secondary prevention of cardioembolic stroke 4. No previous treatment with oral anticoagulants 5. Signed consent before performing a Magnetic Resonance 6. Long-term follow-up will be possible Exclusion Criteria: 1. The patient will receive oral anticoagulation as a primary prevention treatment 2. The etiology that motivates the onset of oral anticoagulants is not cardioembolism 3. Absolute contraindication to receive oral anticoagulants 4. Arterial hypertension that is not controlled, hypertensive crisis 5. Dementia 6. Live-expectancy less than 1 year 7. Any social or psychological reason that prevents follow-up 8. Contraindication to perform a Magnetic Resonance examination 9. Patients who received oral antiacoagulants prior to the current stroke 10. The Magnetic Resonance imaging was performed more than 1 month after the onset of treatment with oral anticoagulants

Additional Information

Official title 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
Principal investigator Joan Martí-Fàbregas, MD,PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.