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

NCT ID: NCT02238470

Last Updated: 2018-08-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2017-09-30

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.

Conditions

Ischemic Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Oral anticoagulants

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

oral anticoagulants

Intervention Type: DRUG

Comparison of patients receiving oral anticoagulants with or without microbleeds in magnetic resonance imaging

Interventions

oral anticoagulants

Comparison of patients receiving oral anticoagulants with or without microbleeds in magnetic resonance imaging

Intervention Type: DRUG

Other Intervention Names

warfarin; coumarin; dabigatran; rivaroxaban; apixaban

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joan Martí-Fàbregas, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Biomedical Research Institute Sant Pau (IIB Sant Pau)

Locations

Arcispedale Santa Maria Nuova IRCCS

Reggio Emilia, , Italy

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Fundació Hospital Asil Granollers

Granollers, Barcelona, Spain

Hospital de Mataró

Mataró, Barcelona, Spain

Hospital Parc Taulí

Sabadell, Barcelona, Spain

Hospital Moisés Broggi

Sant Joan Despí, Barcelona, Spain

Mutua de Terrassa

Terrassa, Barcelona, Spain

Hospital de la Cinta

Tortosa, Tarragona, Spain

Hospital de Albacete

Albacete, , Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Clínic

Barcelona, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital de Basurto

Bilbao, , Spain

Hospital CA de Burgos

Burgos, , Spain

Hospital San Pedro de Alcántara

Cáceres, , Spain

Hospital de Donostia

Donostia / San Sebastian, , Spain

Hospital Virgen de las Nieves

Granada, , Spain

Hospital de León

León, , Spain

Hospital Arnau de Vilanova

Lleida, , Spain

Hospital La Rioja

Logroño, , Spain

Hospital Gregorio Marañón

Madrid, , Spain

Hospital Ramón y Cajal

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Centro Médico Asturias

Oviedo, , Spain

Hospital Son Espases

Palma de Mallorca, , Spain

Hospital de Navarra

Pamplona, , Spain

CHU Santiago de Compostela

Santiago de Compostela, , Spain

Hospital Virgen del Rocío

Seville, , Spain

Hospital La Fe

Valencia, , Spain

Hospital CU de Valladolid

Valladolid, , Spain

Countries

Italy; Spain

References

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.

Reference Type: DERIVED

PMID: 31004066 (View on PubMed)

Other Identifiers

PI11/00296

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IIBSP-ACO-2010-10

Identifier Type: -

Identifier Source: org_study_id