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Completed

NCT Number: NCT02238470

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 65 y
  • TIA or ischemic stroke
  • The patient will receive indefinitely treatment with oral anticoagulants for the secondary prevention of cardioembolic stroke
  • No previous treatment with oral anticoagulants
  • Signed consent before performing a Magnetic Resonance
  • Long-term follow-up will be possible

Exclusion criteria

  • The patient will receive oral anticoagulation as a primary prevention treatment
  • The etiology that motivates the onset of oral anticoagulants is not cardioembolism
  • Absolute contraindication to receive oral anticoagulants
  • Arterial hypertension that is not controlled, hypertensive crisis
  • Dementia
  • Live-expectancy less than 1 year
  • Any social or psychological reason that prevents follow-up
  • Contraindication to perform a Magnetic Resonance examination
  • Patients who received oral antiacoagulants prior to the current stroke
  • The Magnetic Resonance imaging was performed more than 1 month after the onset of treatment with oral anticoagulants

Treatment and study plan

oral anticoagulants

Drug

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

Other names: warfarin, coumarin, dabigatran, rivaroxaban, apixaban

Primary outcomes

  1. Intracranial Hemorrhage

    Time frame: 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 outcomes

  1. Ischemic stroke

    Time frame: within 24 months after inclusion

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Acronym: HERO

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Sep 12, 2014
Registry last updated
Aug 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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