NCT03936361

Brief Summary

The SATURN trial aims to determine whether continuation vs. discontinuation of statin drugs after spontaneous lobar intracerebral hemorrhage (ICH) is the best strategy; and whether the decision to continue/discontinue statins should be influenced by an individual's Apolipoprotein-E (APOE) genotype. An MRI ancillary study (SATURN MRI), in a subset of SATURN participants , will evaluate the effects of continuation vs. discontinuation of statin drugs on hemorrhagic and ischemic MRI markers of cerebral small vessel disease, and whether the presence/burden of hemorrhagic markers (i.e. cerebral microbleeds and/or cortical superficial siderosis) on baseline MRI influences the risk of ICH recurrence on/off statin therapy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,456

participants targeted

Target at P75+ for phase_3

Timeline
42mo left

Started Jun 2020

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Jun 2020Dec 2029

First Submitted

Initial submission to the registry

May 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2019

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 10, 2020

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

8.6 years

First QC Date

May 1, 2019

Last Update Submit

April 19, 2026

Conditions

Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Recurrent symptomatic ICH

    within 24 months

Secondary Outcomes (1)

  • Major Adverse Cerebro- and Cardio-Vascular Events

    Within 24 months

Study Arms (2)

Statin

ACTIVE COMPARATOR

The same statin agent and dose that subjects were using at the time of ICH onset.

Drug: Statins

No-statin

NO INTERVENTION

Subjects will discontinue the statin agent that they were taking at the time of ICH onset. No placebo will be prescribed for these subjects.

Interventions

StatinsDRUG

Statin drugs (already prescribed) at ICH onset will be either continued or discontinued by the participants following qualifying ICH

Also known as: HMG CoA
Statin

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Suspected secondary cause for the qualifying 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
  • Woman of childbearing potential
  • Concurrent participation in another research protocol for investigation of experimental therapy.
  • Indication that withdrawal of care will be implemented for the qualifying ICH.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (4)

  • Marchina S, Yeatts SD, Foster LD, Janis S, Shoamanesh A, Khatri P, Bernstein K, Perlmutter A, Stever C, Heistand EC, Broderick JP, Greenberg SM, Leira EC, Rosand J, Lioutas VA, Salman RAS, Tirschwell D, Marti-Fabregas J, Selim M. Rationale and Design of the Statin Use in Intracerebral Hemorrhage Patients (SATURN) Trial. Cerebrovasc Dis. 2025;54(2):270-277. doi: 10.1159/000538195. Epub 2024 Mar 16.

    PMID: 38493765BACKGROUND

  • Marchina S, Foster LD, Yeatts SD, Khatri P, Bernstein K, Perlmutter A, Heistand EC, Smith EE, Sharma M, Broderick JP, Lioutas VA, Marti-Fabregas J, Selim M, Shoamanesh A. SATURN MRI: study protocol for the statin use in intracerebral hemorrhage patients MRI ancillary study. Trials. 2025 Aug 30;26(1):323. doi: 10.1186/s13063-025-09024-0.

    PMID: 40886018BACKGROUND

  • Zhao W, Yeatts SD, Broderick JP, Selim MH, Adeoye OM, Durkalski-Mauldin VL, Meinzer CN, Martin RH, Dillon CR, Cassarly CN, Pauls KH, Elm JJ. Optimal Randomization Designs for Large Multicenter Clinical Trials: From the National Institutes of Health Stroke Trials Network Funded by National Institutes of Health/National Institute of Neurological Disorders and Stroke Experience. Stroke. 2023 Jul;54(7):1909-1919. doi: 10.1161/STROKEAHA.122.040743. Epub 2023 Apr 20.

    PMID: 37078281BACKGROUND

  • Szejko N, Kirsch E, Falcone GJ. Genetic determinants of LDL cholesterol and risk of intracerebral haemorrhage. Curr Opin Lipidol. 2021 Aug 1;32(4):244-248. doi: 10.1097/MOL.0000000000000761.

    PMID: 34010223DERIVED

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors3-hydroxy-3-methylglutaryl-coenzyme A

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anticholesteremic AgentsHypolipidemic AgentsAntimetabolitesMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesEnzyme InhibitorsLipid Regulating AgentsTherapeutic Uses

Central Study Contacts

Magdy Selim, MD, PhD

CONTACT

617-632-8917mselim@bidmc.harvard.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomized at 1:1 ratio to either continue the same statin drug and dosage that they are taking at the time of ICH onset or to discontinue it for up to 24 months after ICH. No placebo will be prescribed for those randomized to discontinue statins.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

May 1, 2019

First Posted

May 3, 2019

Study Start

June 10, 2020

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 1, 2029

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)