Rationale and Design of the Statins Use in Intracerebral Hemorrhage Patients (SATURN) Trial

Sarah Marchina; Sharon D Yeatts; Lydia D Foster; Scott Janis; Ashkan Shoamanesh; Pooja Khatri; Kimberlee Bernstein; Aaron Perlmutter; Catherine Stever; Elizabeth C Heistand; Joseph P Broderick; Steven M Greenberg; Enrique C Leira; Jonathan Rosand; Vasileios-Arsenios Lioutas; Rustam Al Shahi Salman; David Tirschwell; Joan Marti-Fabregas; Magdy Selim

doi:10.1159/000538195

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Rationale and Design of the Statins Use in Intracerebral Hemorrhage Patients (SATURN) Trial

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Rationale and Design of the Statins Use in Intracerebral Hemorrhage Patients (SATURN) Trial

Sarah Marchina, Sharon D Yeatts, Lydia D Foster, Scott Janis, Ashkan Shoamanesh, Pooja Khatri, Kimberlee Bernstein, Aaron Perlmutter, Catherine Stever, Elizabeth C Heistand, …

Cerebrovascular diseases (Basel, Switzerland), Vol.54(2), pp.270-277

04/2025

DOI: 10.1159/000538195

PMCID: PMC11403066

PMID: 38493765

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https://www.ncbi.nlm.nih.gov/pmc/articles/11403066View

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Abstract

INTRODUCTION The benefits and risks of HMG-CoA reductase inhibitor (statin) drugs in survivors of intracerebral hemorrhage (ICH) are unclear. Observational studies suggest an association between statin use and increased risk of lobar ICH, particularly in patients with apolipoprotein-E (APOE) ε2 and ε4 genotypes. There are no randomized controlled trials (RCTs) addressing the effects of statins after ICH leading to uncertainty as to whether statins should be used in patients with lobar ICH who are at high risk for ICH recurrence. The SATURN trial aims to evaluate the effects of continuation versus discontinuation of statin on the risk of ICH recurrence and ischemic major adverse cerebro-cardio-vascular events (MACCE) in patients with lobar ICH. Secondary aims include the assessment of whether the APOE genotype modifies the effects of statins on ICH recurrence, functional and cognitive outcomes and quality of life. METHODS The SATURN trial is a multi-center, pragmatic, prospective, randomized, open-label, Phase III clinical trial with blinded end-point assessment. A planned total of 1456 patients with lobar ICH will be recruited from 140 sites in the United States, Canada and Spain. Patients presenting within seven days of a spontaneous lobar ICH that occurred while taking a statin, will be randomized (1:1) to continuation (control) vs. discontinuation (intervention) of the same statin drug and dose that they were using at ICH onset. The primary outcome is the time to recurrent symptomatic ICH within a two-year follow-up period. The primary safety outcome is the occurrence of ischemic MACCE.CONCLUSION The results will help to determine the best strategy for statin use in survivors of lobar ICH and may help to identify if there is a subset of patients who would benefit from statins.

Details

Title: Subtitle: Rationale and Design of the Statins Use in Intracerebral Hemorrhage Patients (SATURN) Trial
Creators: Sarah Marchina
Sharon D Yeatts
Lydia D Foster
Scott Janis
Ashkan Shoamanesh
Pooja Khatri
Kimberlee Bernstein
Aaron Perlmutter
Catherine Stever
Elizabeth C Heistand
Joseph P Broderick
Steven M Greenberg
Enrique C Leira
Jonathan Rosand
Vasileios-Arsenios Lioutas
Rustam Al Shahi Salman
David Tirschwell
Joan Marti-Fabregas
Magdy Selim
Resource Type: Journal article
Publication Details: Cerebrovascular diseases (Basel, Switzerland), Vol.54(2), pp.270-277
DOI: 10.1159/000538195
PMID: 38493765
PMCID: PMC11403066
NLM abbreviation: Cerebrovasc Dis
ISSN: 1015-9770
eISSN: 1421-9786
Publisher: Karger
Language: English
Electronic publication date: 03/16/2024
Date published: 04/2025
Academic Unit: Neurology; Epidemiology; Iowa Neuroscience Institute; Neurosurgery
Record Identifier: 9984573826702771

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