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StATins Use in IntRacerebral Hemorrhage PatieNts

Overview

Información sobre este estudio

The purpose of this study is to determine the effects of continuation vs. discontinuation of statins on the risk of Intracerebral Hemorrhage (ICH) recurrence during 24 months of follow-up in patients presenting with a spontaneous lobar Intracerebral Hemorrhage (lCH) while taking a statin drug. And we will also determine the effects of continuation vs. discontinuation of statins on the occurrence of any of the following major adverse cerebro- and cardio-vascular events (MACCE) (symptomatic ischemic stroke, symptomatic myocardial infarction, newly symptomatic arterial occlusive disease (peripheral, retinal, or carotid), revascularization procedures for coronary, carotid, or peripheral arterial disease, and vascular death). 

An ancillary MRI study will be performed in a subset of SATURN participants (n= 894). Participation in the MRI study is optional. Participants will undergo a standardized brain MRI protocol including susceptibility-weighted or gradient-echo T2*-weighted imaging, during hospitalization within 7 days of randomization into SATURN and at the end of the 24-month follow-upperiod.

 

 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Age ≥ 50 years.
  • Spontaneous lobar intracerebral hemorrhage (ICH) confirmed by computerized tomography (CT) or magnetic resonance imaging (MRI) scan.
  • Patient was taking a statin drug at the onset of the qualifying/index intracerebral hemorrhage (ICH).
  • Randomization must be carried out within 7 days of the onset of the qualifying intracerebral hemorrhage (ICH).
  • Patient or legally authorized representative, after consultation with physicians, agrees to be randomized to statin continuation (restart) vs. discontinuation.

ELIGIBILITY CRITERIA: Participants in SATURN MRI must meet all of the above eligibility criteria, in addition to:

1- Subject or surrogate provides signed informe consent and opt to participate in the MRI study.

2- Subject has no known contraindications to MRI such as claustrophobia, metal implants, or pacemaker.

Exclusion Criteria:

  • Suspected secondary cause for the qualifying intracerebral hemorrhage (ICH), such as an underlying vascular abnormality or tumor, trauma, venous infarction, or hemorrhagic transformation of an ischemic infarct.
  • History of recent myocardial infarction (attributed to coronary artery disease) or unstable angina within the previous 3 months.
  • Diabetic patients with history of myocardial infarction or coronary revascularization.
  • History of familial hypercholesterolemia.
  • Patients receiving proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors.
  • Known diagnosis of severe dementia.
  • Inability to obtain informed consent.
  • Patients known or suspected of not being able to comply with the study protocol due to alcoholism, drug dependency, or other obvious reasons for noncompliance, such as unable to adhere to the protocol specified visits/assessments.
  • Life expectancy of less than 24 months due to co-morbid terminal conditions.
  • Pre-morbid mRS > 3.
  • ICH score > 3 upon presentation.
  • Contraindications to continuation/resumption of statin therapy, such as significant elevations of serum creatinine kinase and/or liver transaminases, and rhabdomyolysis.
  • Concurrent participation in another research protocol for investigation of experimental therapy.
  • Women of childbearing potential.
  • Indication that withdrawal of care will be implemented for the qualifying intracerebral hemorrhage (ICH).

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Jeffrey Peel, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20492790

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