Evidence map›Paper›PMID 38493765›Full record

ArticleCerebrovascular diseases (Basel, Switzerland)2025

Rationale and Design of the Statin 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 and 9 more

Registry-linked trialOpen access · greenAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Cerebrovascular diseases (Basel, Switzerland), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03936361 (STATINS USE IN INTRACEREBRAL HEMORRHAGE PATIENTS), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
3.7field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03936361 phase3recruitingnot on this map

Statins use in intracerebral hemorrhage patients

TypeinterventionalSponsorBeth Israel Deaconess Medical CenterRan2020 to 2029Enrolled1,456ConditionsIntracerebral HemorrhageArmsStatins
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Leveraging Mendelian randomization to inform drug discovery and development for ischemic stroke.Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism · 2026
    Review
  3. Article
  4. Article
  5. Article
  6. New targets in spontaneous intracerebral hemorrhage.Current opinion in neurology · 2025
    Review
  7. Review
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 8 institutions in 3 countries.

Sarah MarchinaDepartment of Neurology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA, smarchin@bidmc.harvard.edu.
Sharon D YeattsDepartment of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.
Lydia D FosterDepartment of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.
Scott JanisDivision of Clinical Research, National Institute of Neurological Disorders and Stroke, Bethesda, Maryland, USA.
Ashkan ShoamaneshMedicine/Neurology, McMaster University/Population Health Research Institute, Hamilton, Ontario, Canada.
Pooja KhatriDepartment of Neurology, University of Cincinnati, Cincinnati, Ohio, USA.
Kimberlee BernsteinDepartment of Neurology, University of Cincinnati, Cincinnati, Ohio, USA.
Aaron PerlmutterDepartment of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.
Catherine SteverDepartment of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.
Elizabeth C HeistandDepartment of Neurology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA.
Joseph P BroderickDepartment of Neurology, University of Cincinnati, Cincinnati, Ohio, USA.
Steven M GreenbergDepartment of Neurology, McCance Center for Brain Health, Massachusetts General Hospital, Boston, Massachusetts, USA.
Enrique C LeiraDepartment of Neurology, Neurosurgery and Epidemiology, University of Iowa, Iowa City, Iowa, USA.
Jonathan RosandDepartment of Neurology, McCance Center for Brain Health, Massachusetts General Hospital, Boston, Massachusetts, USA.
Vasileios-Arsenios LioutasDepartment of Neurology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA.
Rustam Al Shahi SalmanCentre for Clinical Brain Sciences, The University of Edinburgh, Edinburgh, UK.
David TirschwellDepartment of Neurology, University of Washington, Seattle, Washington, USA.
Joan Marti-FabregasDepartment of Neurology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Magdy SelimDepartment of Neurology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA.
Medical University of South Carolina · USUniversity of Cincinnati · USHarvard University · USBeth Israel Deaconess Medical Center · USHospital de Sant Pau · ESNational Institute of Neurological Disorders and Stroke · USUniversity of Edinburgh · GBUniversity of Washington · US

Funding

StATins Use in intRacerebral hemorrhage patieNts (SATURN)U01NS102289 · NINDS · BETH ISRAEL DEACONESS MEDICAL CENTER · PI Magdy H Selim · 2019 to 2026
$15.7M
StAtins Use in intRacereberal hemorrhage patieNts MRI (SATURN MRI) Ancillary StudyUF1NS120871 · NINDS · BETH ISRAEL DEACONESS MEDICAL CENTER · PI SELIM, MAGDY H, SHOAMANESH, ASHKAN · 2021 to 2021
$2.7M
NINDS NIH HHS U01 NS102289NINDS NIH HHS UF1 NS120871
6 · The paper itself

Abstract

introductionThe 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 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 (MACCEs) 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.

methodsThe SATURN trial is a multi-center, pragmatic, prospective, randomized, open-label, phase III clinical trial with blinded end-point assessment. A planned total of 1,456 patients with lobar ICH will be recruited from 140 sites in the USA, Canada, and Spain. Patients presenting within 7 days of a spontaneous lobar ICH that occurred while taking a statin will be randomized (1:1) to continuation (control) versus 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 2-year follow-up period. The primary safety outcome is the occurrence of ischemic MACCE.

conclusionThe 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 or be harmed by statins.

introductionThe 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 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 (MACCEs) 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.

methodsThe SATURN trial is a multi-center, pragmatic, prospective, randomized, open-label, phase III clinical trial with blinded end-point assessment. A planned total of 1,456 patients with lobar ICH will be recruited from 140 sites in the USA, Canada, and Spain. Patients presenting within 7 days of a spontaneous lobar ICH that occurred while taking a statin will be randomized (1:1) to continuation (control) versus 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 2-year follow-up period. The primary safety outcome is the occurrence of ischemic MACCE.

conclusionThe 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 or be harmed by statins.

Indexed as

Cerebral HemorrhageHydroxymethylglutaryl-CoA Reductase InhibitorsClinical Trials, Phase III as TopicCognitionHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicProspective StudiesQuality of LifeRandomized Controlled Trials as TopicRecurrenceRisk AssessmentRisk FactorsTime FactorsTreatment OutcomeHydroxymethylglutaryl-CoA Reductase InhibitorsCardiovascular eventsIntracerebral hemorrhageLobar intracerebral hemorrhageOutcomeRecurrent intracerebral hemorrhageStatin

Identifiers

PMID38493765
PMCPMC11403066
OpenAlexW4394741900

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.