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

Ischemic Stroke Clinical Trial

— HERO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02238470
• Other study ID #: IIBSP-ACO-2010-10
• Secondary ID: PI11/00296
• Status: Completed
• Start date: April 2012
• Est. completion date: September 2017

Study information

• Verified date: August 2018
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Cerebral Infarction
• Hemorrhage
• Ischemia
• Ischemic Stroke
• Leukoaraiosis
• Stroke

Intervention

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

Locations

Country	Name	City	State
Italy	Arcispedale Santa Maria Nuova IRCCS	Reggio Emilia
Spain	Hospital de Albacete	Albacete
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clínic	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	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
Spain	Hospital Virgen de las Nieves	Granada
Spain	Fundació Hospital Asil Granollers	Granollers	Barcelona
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	Hospital de Mataró	Mataró	Barcelona
Spain	Centro Médico Asturias	Oviedo
Spain	Hospital Son Espases	Palma de Mallorca
Spain	Hospital de Navarra	Pamplona
Spain	Hospital Parc Taulí	Sabadell	Barcelona
Spain	Hospital Moisés Broggi	Sant Joan Despí	Barcelona
Spain	CHU Santiago de Compostela	Santiago de Compostela
Spain	Hospital Virgen del Rocío	Sevilla
Spain	Mutua de Terrassa	Terrassa	Barcelona
Spain	Hospital de la Cinta	Tortosa	Tarragona
Spain	Hospital La Fe	Valencia
Spain	Hospital CU de Valladolid	Valladolid

Sponsors (1)

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

Countries where clinical trial is conducted

Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ischemic stroke		within 24 months after inclusion