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

Completed

• Conditions: Ischemic Stroke
• Interventions: Drug: oral anticoagulants

• Registration Number: NCT02238470
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2014-09-10
• Study First Submitted QC: 2014-09-10
• Study First Posted: 2014-09-12
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oral anticoagulants	oral anticoagulants	Patients who will receive oral anticoagulants indefinitely for the secondary prevention of cardioembolic stroke

Primary Outcome Measures

Name	Time	Method
Intracranial Hemorrhage	every 3 months after stroke, until 24 months	Telephone interview every 3 months, starting 3 months after ischemic stroke (3, 6, 9, 12, 15, 18, 21 and 24 months)

Secondary Outcome Measures

Name	Time	Method
Ischemic stroke	within 24 months after inclusion

Trial Locations

Locations (30)

CHU Santiago de Compostela; 🇪🇸 Santiago de Compostela, Spain

Hospital Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain

Hospital de la Cinta; 🇪🇸 Tortosa, Tarragona, Spain

Hospital San Pedro de Alcántara; 🇪🇸 Cáceres, Spain

Mutua de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital de Basurto; 🇪🇸 Bilbao, Spain

Centro Médico Asturias; 🇪🇸 Oviedo, Spain

Hospital de León; 🇪🇸 León, Spain

Hospital Arnau de Vilanova; 🇪🇸 Lleida, Spain

Arcispedale Santa Maria Nuova IRCCS; 🇮🇹 Reggio Emilia, Italy

Hospital CA de Burgos; 🇪🇸 Burgos, Spain

Hospital Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Son Espases; 🇪🇸 Palma de Mallorca, Spain

Hospital Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital La Fe; 🇪🇸 Valencia, Spain

Hospital CU de Valladolid; 🇪🇸 Valladolid, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Fundació Hospital Asil Granollers; 🇪🇸 Granollers, Barcelona, Spain

Hospital de Mataró; 🇪🇸 Mataró, Barcelona, Spain

Hospital Clínic; 🇪🇸 Barcelona, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital de Donostia; 🇪🇸 Donostia, Spain

Hospital de Albacete; 🇪🇸 Albacete, Spain

Hospital Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital La Rioja; 🇪🇸 Logroño, Spain

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital de Navarra; 🇪🇸 Pamplona, Spain

Hospital Moisés Broggi; 🇪🇸 Sant Joan Despí, Barcelona, Spain