Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1456 participants
INTERVENTIONAL
2020-06-10
2028-12-31
Brief Summary
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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.
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Detailed Description
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Recruitment will take place at \~ 140 sites coordinated through the NIH/NINDS StrokeNet and the Canadian Stroke Consortium.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Statin
The same statin agent and dose that subjects were using at the time of ICH onset.
Statins
Statin drugs (already prescribed) at ICH onset will be either continued or discontinued by the participants following qualifying ICH
No-statin
Subjects will discontinue the statin agent that they were taking at the time of ICH onset. No placebo will be prescribed for these subjects.
No interventions assigned to this group
Interventions
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Statins
Statin drugs (already prescribed) at ICH onset will be either continued or discontinued by the participants following qualifying ICH
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Spontaneous lobar ICH confirmed by CT or MRI scan
3. Patient was taking a statin drug at the onset of the qualifying/index ICH
4. Randomization can be carried out within 7 days of the onset of the qualifying ICH
5. Patient or legally authorized representative, after consultation with the statin prescriber, agrees to be randomized to statin continuation (restart) vs. discontinuation
Exclusion Criteria
2. History of recent myocardial infarction (attributed to coronary artery disease) or unstable angina within the previous 3 months
3. Diabetic patients with history of myocardial infarction or coronary revascularization
4. History of familial hypercholesterolemia
5. Patients receiving proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors
6. Known diagnosis of severe dementia
7. Inability to obtain informed consent
8. 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.
9. Life expectancy of less than 24 months due to co-morbid terminal conditions.
10. Pre-morbid mRS \>3
11. ICH score \>3 upon presentation.
12. Contraindications to continuation/resumption of statin therapy, such as significant elevations of serum creatinine kinase and/or liver transaminases, and rhabdomyolysis
13. Woman of childbearing potential
14. Concurrent participation in another research protocol for investigation of experimental therapy.
15. Indication that withdrawal of care will be implemented for the qualifying ICH.
50 Years
ALL
No
Sponsors
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NINDS Stroke Trials Network (StrokeNet)
OTHER
Canadian Stroke Consortium (CSC)
OTHER
University of Cincinnati
OTHER
Medical University of South Carolina
OTHER
Yale University
OTHER
MetroHealth Medical Center
OTHER
UH, Cleveland Medical Center
UNKNOWN
Spectrum Health Hospitals
OTHER
West Virginia University
OTHER
Columbia University
OTHER
Weill Medical College of Cornell University
OTHER
New York Presbyterian Brooklyn Methodist Hospital
OTHER
Buffalo General Medical Center
UNKNOWN
State University of New York - Upstate Medical University
OTHER
St. Joseph's Regional Medical Center, New Jersey
OTHER
Tufts Medical Center
OTHER
Massachusetts General Hospital
OTHER
UMass Memorial Health
OTHER
Brigham and Women's Hospital
OTHER
Baystate Medical Center
OTHER
University of Vermont Medical Center
OTHER
Lahey Hospital & Medical Center
OTHER
Augusta University Medical Center
UNKNOWN
Prisma Health-Upstate
OTHER
The Moses H. Cone Memorial Hospital
OTHER
University of Virginia
OTHER
George Washington University
OTHER
University of Maryland, Baltimore
OTHER
Mount Sinai Hospital, New York
OTHER
NYU Langone Medical Center - Tisch Hospital
UNKNOWN
Montefiore Medical Center
OTHER
NYU Langone Hospital - Brooklyn
UNKNOWN
Froedtert Hospital
OTHER
Central DuPage Hospital
OTHER
Rush University Medical Center
OTHER
Loyola University
OTHER
Stanford University
OTHER
Mercy San Juan Medical Center
UNKNOWN
Oregon Health and Science University
OTHER
Kaiser Permanente
OTHER
University of Southern California
OTHER
Cedars-Sinai Medical Center
OTHER
University of New Mexico
OTHER
Long Beach Memorial Medical Center
OTHER
University of California, Irvine
OTHER
Arrowhead Regional Medical Center
OTHER
Huntington Memorial Hospital
OTHER
Scripps Health
OTHER
University of California, San Diego
OTHER
Ochsner Health System
OTHER
St. Joseph's Hospital and Medical Center, Phoenix
OTHER
Desert Care Network
UNKNOWN
Eden Medical Center
UNKNOWN
San Francisco General Hospital
OTHER
University of California, San Francisco
OTHER
University of Louisville
OTHER
Ohio State University
OTHER
University of Iowa
OTHER
Sanford Medical Center Fargo
UNKNOWN
University of Nebraska
OTHER
Tampa General Hospital
OTHER
University of Florida
OTHER
Jackson Health System
OTHER
Mayo Clinic
OTHER
Baptist Medical Center Jacksonville
UNKNOWN
Wayne State University
OTHER
University of Michigan
OTHER
Mercy Health Saint Mary Grand Rapids
UNKNOWN
Metro Health, Michigan
OTHER
University of Kentucky
OTHER
McLaren Health Care
OTHER
Regions Hospital
OTHER
Allina Health System
OTHER
University of Kansas
OTHER
University of Minnesota
OTHER
St. Cloud Hospital
UNKNOWN
Milton S. Hershey Medical Center
OTHER
Abington Memorial Hospital
OTHER
Temple University
OTHER
University of Pennsylvania
OTHER
Lehigh Valley Hospital
OTHER
York Hospital, York, PA
OTHER
Thomas Jefferson University
OTHER
University of Pittsburgh
OTHER
St. David's HealthCare
OTHER
Baylor College of Medicine
OTHER
Tulane Medical Center
UNKNOWN
The University of Texas Health Science Center at San Antonio
OTHER
OU Medical Center
UNKNOWN
University of Utah
OTHER
Swedish Medical Center
OTHER
St. Mary's Medical Center
OTHER
Banner University Medical Center
OTHER
Intermountain Medical Center
OTHER
Legacy Emanuel Medical Center
UNKNOWN
Sacred Heart Medical Center Springfield
UNKNOWN
Harborview Injury Prevention and Research Center
OTHER
University of Wisconsin, Madison
OTHER
Aurora BayCare Medical Center
OTHER
Wake Forest University Health Sciences
OTHER
University of Alabama at Birmingham
OTHER
University of South Alabama
OTHER
Carolinas Medical Center
OTHER
Barnes-Jewish Hospital
OTHER
St. Luke's Hospital, Kansas City, Missouri
OTHER
University of Arkansas
OTHER
OSF Healthcare System
OTHER
Cox Medical Center South
UNKNOWN
North Shore University Hospital
OTHER
Rhode Island Hospital
OTHER
Hartford Hospital
OTHER
Staten Island University Hospital
OTHER
Johns Hopkins University
OTHER
University of North Carolina, Chapel Hill
OTHER
University of Alberta
OTHER
The Ottawa Hospital
OTHER
London Health Sciences Centre
OTHER
Hamilton General Hospital
UNKNOWN
Hopital de l'Enfant-Jesus
OTHER
Montreal Neurological Institute and Hospital
OTHER
Foothills Medical Centre
OTHER
University Health Network, Toronto
OTHER
Health Sciences Centre, Winnipeg, Manitoba
OTHER
Thunder Bay Regional Health Sciences Centre
OTHER
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre
UNKNOWN
Fraser Health
OTHER
Hopital de Chicoutimi
UNKNOWN
Université de Sherbrooke
OTHER
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Magdy H Selim, MD, PhD
Professor of Neurology
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Magdy Selim, MD, PhD
Role: primary
References
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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.
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.
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.
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.
Other Identifiers
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2018C000515
Identifier Type: -
Identifier Source: org_study_id
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