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Ischemic StrokeHERONCT02238470

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

An observational study of Ischemic Stroke, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 30 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Ischemic Stroke
What is being tested?
oral anticoagulants
Type of treatment
Pill or oral medicine
How many people
1,000 participants
Where
30 sitesin 2 countries
Study dates
Apr 2012to Sep 2017
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Patients admitted to tertiaty hospital for cardioembolic ischemic stroke

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

30 sites in 2 countries.

30 sites in 2 countries

Spain29 sites

  • Hospital de Albacete

    Albacete

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Clínic

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital de Basurto

    Bilbao

  • Hospital CA de Burgos

    Burgos

  • Hospital San Pedro de Alcántara

    Cáceres

  • Hospital de Donostia

    Donostia / San Sebastian

  • Hospital Virgen de las Nieves

    Granada

  • Fundació Hospital Asil Granollers

    Granollers, Barcelona

  • Hospital de León

    León

  • Hospital Arnau de Vilanova

    Lleida

  • Hospital La Rioja

    Logroño

  • Hospital Gregorio Marañón

    Madrid

  • Hospital Ramón y Cajal

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital de Mataró

    Mataró, Barcelona

  • Centro Médico Asturias

    Oviedo

  • Hospital Son Espases

    Palma de Mallorca

  • Hospital de Navarra

    Pamplona

  • Hospital Parc Taulí

    Sabadell, Barcelona

  • Hospital Moisés Broggi

    Sant Joan Despí, Barcelona

  • CHU Santiago de Compostela

    Santiago de Compostela

  • Hospital Virgen del Rocío

    Seville

  • Mutua de Terrassa

    Terrassa, Barcelona

  • Hospital de la Cinta

    Tortosa, Tarragona

  • Hospital La Fe

    Valencia

  • Hospital CU de Valladolid

    Valladolid

Other trials in Spain

Italy1 site

  • Arcispedale Santa Maria Nuova IRCCS

    Reggio Emilia

Other trials in Italy

About this study

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

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

Read the 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
Being tested
oral anticoagulants
Keywords
Ischemic stroke, Intracerebral hemorrhage, Subdural hemorrhage, Microbleed, Leukoaraiosis, Oral anticoagulants
Medical subject headings
Ischemic Stroke, Cerebral Hemorrhage, Hematoma, Subdural, Leukoaraiosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • oral anticoagulantsDrug

    Also called warfarin, coumarin, dabigatran, rivaroxaban

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

Study groups in NCT02238470
Study groupRoleWhat they receive
Oral anticoagulantsPatients who will receive oral anticoagulants indefinitely for the secondary prevention of cardioembolic stroke
Receives: Drug: oral anticoagulants

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intracranial Hemorrhage

    Telephone interview every 3 months, starting 3 months after ischemic stroke (3, 6, 9, 12, 15, 18, 21 and 24 months)

    Measured: every 3 months after stroke, until 24 months

Secondary outcomes (1)

  1. Ischemic stroke

    Measured: within 24 months after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2014 (estimated)
  2. Study startApr 2012
  3. Primary completionSep 2017
  4. Study completionSep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (actual)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02238470
Sponsor's protocol ID
IIBSP-ACO-2010-10
Other IDs
PI11/00296
Acronym
HERO
Status last verified
Aug 2018
First submitted
10 Sep 2014
Last updated
3 Aug 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 31004066

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Stroke, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 30 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Spain, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intracranial Hemorrhage (time frame: every 3 months after stroke, until 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02238470, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.

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