Clinical trial NCT02238470: Intracerebral Hemorrhage Due to Oral Anticoagulants: Prediction of the Risk by Magnetic Resonance
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Keywords: Ischemic stroke
Intracerebral hemorrhage
Subdural hemorrhage
Microbleed
Leukoaraiosis
Oral anticoagulants
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to tertiaty hospital for cardioembolic ischemic stroke

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Intracranial Hemorrhage
timeFrame: every 3 months after stroke, until 24 months
Secondary outcomes:
measure: Ischemic stroke
timeFrame: within 24 months after inclusion
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova IRCCS
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Granollers
country: Spain
facility: Fundació Hospital Asil Granollers
state: Barcelona
city: Mataró
country: Spain
facility: Hospital de Mataró
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Parc Taulí
state: Barcelona
city: Sant Joan Despí
country: Spain
facility: Hospital Moisés Broggi
state: Barcelona
city: Terrassa
country: Spain
facility: Mutua de Terrassa
state: Barcelona
city: Tortosa
country: Spain
facility: Hospital de la Cinta
state: Tarragona
city: Albacete
country: Spain
facility: Hospital de Albacete
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clínic
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Burgos
country: Spain
facility: Hospital CA de Burgos
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: Donostia
country: Spain
facility: Hospital de Donostia
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: León
country: Spain
facility: Hospital de León
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova
city: Logroño
country: Spain
facility: Hospital La Rioja
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Oviedo
country: Spain
facility: Centro Médico Asturias
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
city: Pamplona
country: Spain
facility: Hospital de Navarra
city: Santiago de Compostela
country: Spain
facility: CHU Santiago de Compostela
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital La Fe
city: Valladolid
country: Spain
facility: Hospital CU de Valladolid
Study officials:
affiliation: Biomedical Research Institute Sant Pau (IIB Sant Pau)
name: Joan Martí-Fàbregas, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marti-Fabregas J, Medrano-Martorell S, Merino E, Prats-Sanchez L, Marin R, Delgado-Mederos R, Martinez-Domeno A, Camps-Renom P, Jimenez-Xarrie E, Zedde M, Gomez-Choco M, Lara L, Boix A, Calleja A, De Arce-Borda AM, Bravo Y, Fuentes B, Hernandez-Perez M, Canovas D, Llull L, Zandio B, Freijo M, Casado-Naranjo I, Sanahuja J, Cocho D, Krupinski J, Rodriguez-Campello A, Palomeras E, De Felipe A, Serrano M, Zapata-Arriaza E, Zaragoza-Brunet J, Diaz-Maroto I, Fernandez-Dominguez J, Lago A, Maestre J, Rodriguez-Yanez M, Gich I; HERO study investigators. MRI predicts intracranial hemorrhage in patients who receive long-term oral anticoagulation. Neurology. 2019 May 21;92(21):e2432-e2443. doi: 10.1212/WNL.0000000000007532. Epub 2019 Apr 19.