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NCT Number: NCT03936361

Statins In Intracerbral Hemorrhage

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.

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Key information

Conditions

Intracerebral Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Magdy Selim, MD, PhD

CONTACT

About this study

SATURN is a multi-center, pragmatic, prospective, randomized, open-label, and blinded end-point assessment (PROBE) clinical trial. A total of 1,456 patients presenting within 7 days of a spontaneous lobar ICH while taking statins will be randomized to one of two treatment strategies: discontinuation vs. continuation of statin therapy (using the same agent and dose that they were using at ICH onset). Participating subjects will undergo baseline testing for APOE genotype and will be followed for 24 months to assess for the occurrence of recurrent symptomatic ICH or major adverse cerebro-/cardio-vascular events (MACCE) during the follow-up period. A subset of SATURN participants will participate in the optional MRI study, where they will undergo a baseline MRI within 7 days of randomization into SATURN and a repeat MRI at the end of the follow-up period.

Recruitment will take place at ~ 140 sites coordinated through the NIH/NINDS StrokeNet and the Canadian Stroke Consortium.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Statins

Drug

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

Other names: HMG CoA

Primary outcomes

  1. Recurrent symptomatic ICH

    Time frame: within 24 months

Secondary outcomes

  1. Major Adverse Cerebro- and Cardio-Vascular Events

    Time frame: Within 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Magdy Selim, MD, PhD

CONTACT

[email protected]

617-632-8917

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Abington Memorial Hospital
  • Allina Health System
  • Arrowhead Regional Medical Center
  • Augusta University Medical Center
  • Aurora BayCare Medical Center
  • Banner University Medical Center
  • Baptist Medical Center Jacksonville
  • Barnes-Jewish Hospital
  • Baylor College of Medicine
  • Baystate Medical Center
  • Brigham and Women's Hospital
  • Buffalo General Medical Center
  • Canadian Stroke Consortium (CSC)
  • Carolinas Medical Center
  • Cedars-Sinai Medical Center
  • Central DuPage Hospital
  • Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre
  • Columbia University
  • Corewell Health West
  • Cox Medical Center South
  • Desert Care Network
  • Eden Medical Center
  • Foothills Medical Centre
  • Fraser Health
  • Froedtert Hospital
  • George Washington University
  • Hamilton General Hospital
  • Harborview Injury Prevention and Research Center
  • Hartford Hospital
  • Health Sciences Centre, Winnipeg, Manitoba
  • Hopital de Chicoutimi
  • Hopital de l'Enfant-Jesus
  • Huntington Memorial Hospital
  • Intermountain Health Care, Inc.
  • Jackson Health System
  • Johns Hopkins University
  • Kaiser Permanente
  • Lahey Hospital & Medical Center
  • Legacy Emanuel Medical Center
  • Lehigh Valley Hospital
  • London Health Sciences Centre
  • Long Beach Memorial Medical Center
  • Loyola University
  • Massachusetts General Hospital
  • Mayo Clinic
  • McLaren Health Care
  • Medical University of South Carolina
  • Mercy Health Saint Mary Grand Rapids
  • Mercy San Juan Medical Center
  • Metro Health, Michigan
  • MetroHealth Medical Center
  • Milton S. Hershey Medical Center
  • Montefiore Medical Center
  • Montreal Neurological Institute and Hospital
  • Mount Sinai Hospital, New York
  • NINDS Stroke Trials Network (StrokeNet)
  • NYU Langone Hospital - Brooklyn
  • NYU Langone Medical Center - Tisch Hospital
  • New York Presbyterian Brooklyn Methodist Hospital
  • North Shore University Hospital
  • OSF Healthcare System
  • OU Medical Center
  • Ochsner Health System
  • Ohio State University
  • Oregon Health and Science University
  • Prisma Health-Upstate
  • Regions Hospital
  • Rhode Island Hospital
  • Rush University Medical Center
  • Sacred Heart Medical Center Springfield
  • San Francisco General Hospital
  • Sanford Medical Center Fargo
  • Scripps Health
  • St. Cloud Hospital
  • St. David's HealthCare
  • St. Joseph's Hospital and Medical Center, Phoenix
  • St. Joseph's Regional Medical Center, New Jersey
  • St. Luke's Hospital, Kansas City, Missouri
  • St. Mary's Medical Center
  • Stanford University
  • State University of New York - Upstate Medical University
  • Staten Island University Hospital
  • Swedish Medical Center
  • Tampa General Hospital
  • Temple University
  • The Moses H. Cone Memorial Hospital
  • The Ottawa Hospital
  • The University of Texas Health Science Center at San Antonio
  • Thomas Jefferson University
  • Thunder Bay Regional Health Sciences Centre
  • Tufts Medical Center
  • Tulane Medical Center
  • UH, Cleveland Medical Center
  • UMass Memorial Health
  • University Health Network, Toronto
  • University of Alabama at Birmingham
  • University of Alberta
  • University of Arkansas
  • University of California, Irvine
  • University of California, San Diego
  • University of California, San Francisco
  • University of Cincinnati
  • University of Florida
  • University of Iowa
  • University of Kansas
  • University of Kentucky
  • University of Louisville
  • University of Maryland, Baltimore
  • University of Michigan
  • University of Minnesota
  • University of Nebraska
  • University of New Mexico
  • University of North Carolina, Chapel Hill
  • University of Pennsylvania
  • University of Pittsburgh
  • University of South Alabama
  • University of Southern California
  • University of Utah
  • University of Vermont Medical Center
  • University of Virginia
  • University of Wisconsin, Madison
  • Université de Sherbrooke
  • Wake Forest University Health Sciences
  • Wayne State University
  • Weill Medical College of Cornell University
  • West Virginia University
  • Yale University
  • York Hospital, York, PA

Registry information

Official study title

STATINS USE IN INTRACEREBRAL HEMORRHAGE PATIENTS

Acronym: SATURN

Important dates

Study start
2020
Primary completion
2028
Study completion
2029
First posted
May 3, 2019
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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