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Statins In Intracerbral Hemorrhage

Study acronym: SATURN
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Jun 30, 2027 to Dec 31, 2028 Completion date: Dec 31, 2028 to Dec 2029v11 Show 1 more changeShow less
    • Completion date: Dec 31, 2028 to Dec 2029
  2. Notable Primary completion date: Jun 30, 2026 to Jun 30, 2027 Completion date: Dec 31, 2026 to Dec 31, 2028 · Publications: 3 to 5v10 Show 2 more changesShow less
    • Completion date: Dec 31, 2026 to Dec 31, 2028
    • Publications: 3 to 5

    See this version in full on ClinicalTrials.gov ↗

  3. Minor 2 versions Re-verified since Jul 10, 2023, no change to tracked fieldsv8-v9
  4. Minor Study description expanded, about 37 words Collaborators: 4 to 128v7 Show 1 more changeShow less
  5. Minor Eligibility criteria expanded, about 2 wordsv6 See this version in full on ClinicalTrials.gov ↗
Show 4 earlier versionsHide 4 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Primary completion date: Mar 2026 to Jun 30, 2026 · Completion date: Nov 2026 to Dec 31, 2026 · 1 morev5 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Mar 2026 to Jun 30, 2026
    • Completion date: Nov 2026 to Dec 31, 2026
    • Start date changed from estimate of Jul 2020 to Jun 10, 2020
  2. Notable Start date: Apr 1, 2020 to Jul 2020 Primary completion date: Mar 1, 2026 to Mar 2026 · Completion date: Nov 1, 2026 to Nov 2026v4 Show 2 more changesShow less
    • Primary completion date: Mar 1, 2026 to Mar 2026
    • Completion date: Nov 1, 2026 to Nov 2026
  3. Notable Start date: Nov 1, 2019 to Apr 1, 2020 Eligibility criteria expanded, about 4 wordsv3 Show 1 more changeShow less
    • Eligibility criteria expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  4. Minor Study Identification, Study Statusv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT03936361
Lead Sponsor Beth Israel Deaconess Medical Center
Collaborators: NINDS Stroke Trials Network (StrokeNet), Canadian Stroke Consortium (CSC), University of Cincinnati, Medical University of South Carolina, Yale University, MetroHealth Medical Center, UH, Cleveland Medical Center, Corewell Health West, West Virginia University, Columbia University, Weill Medical College of Cornell University, New York Presbyterian Brooklyn Methodist Hospital, Buffalo General Medical Center, State University of New York - Upstate Medical University, St. Joseph's Regional Medical Center, New Jersey, Tufts Medical Center, Massachusetts General Hospital, UMass Memorial Health, Brigham and Women's Hospital, Baystate Medical Center, University of Vermont Medical Center, Lahey Hospital & Medical Center, Augusta University Medical Center, Prisma Health-Upstate, The Moses H. Cone Memorial Hospital, University of Virginia, George Washington University, University of Maryland, Baltimore, Mount Sinai Hospital, New York, NYU Langone Medical Center - Tisch Hospital, Montefiore Medical Center, NYU Langone Hospital - Brooklyn, Froedtert Hospital, Central DuPage Hospital, Rush University Medical Center, Loyola University, Stanford University, Mercy San Juan Medical Center, Oregon Health and Science University, Kaiser Permanente, University of Southern California, Cedars-Sinai Medical Center, University of New Mexico, Long Beach Memorial Medical Center, University of California, Irvine, Arrowhead Regional Medical Center, Huntington Memorial Hospital, Scripps Health, University of California, San Diego, Ochsner Health System, St. Joseph's Hospital and Medical Center, Phoenix, Desert Care Network, Eden Medical Center, San Francisco General Hospital, University of California, San Francisco, University of Louisville, Ohio State University, University of Iowa, Sanford Medical Center Fargo, University of Nebraska, Tampa General Hospital, University of Florida, Jackson Health System, Mayo Clinic, Baptist Medical Center Jacksonville, Wayne State University, University of Michigan, Mercy Health Saint Mary Grand Rapids, Metro Health, Michigan, University of Kentucky, McLaren Health Care, Regions Hospital, Allina Health System, University of Kansas, University of Minnesota, St. Cloud Hospital, Milton S. Hershey Medical Center, Abington Memorial Hospital, Temple University, University of Pennsylvania, Lehigh Valley Hospital, York Hospital, York, PA, Thomas Jefferson University, University of Pittsburgh, St. David's HealthCare, Baylor College of Medicine, Tulane Medical Center, The University of Texas Health Science Center at San Antonio, OU Medical Center, University of Utah, Swedish Medical Center, St. Mary's Medical Center, Banner University Medical Center, Intermountain Health Care, Inc., Legacy Emanuel Medical Center, Sacred Heart Medical Center Springfield, Harborview Injury Prevention and Research Center, University of Wisconsin, Madison, Aurora BayCare Medical Center, Wake Forest University Health Sciences, University of Alabama at Birmingham, University of South Alabama, Carolinas Medical Center, Barnes-Jewish Hospital, St. Luke's Hospital, Kansas City, Missouri, University of Arkansas, OSF Healthcare System, Cox Medical Center South, North Shore University Hospital, Rhode Island Hospital, Hartford Hospital, Staten Island University Hospital, Johns Hopkins University, University of North Carolina, Chapel Hill, University of Alberta, The Ottawa Hospital, London Health Sciences Centre, Hamilton General Hospital, Hopital de l'Enfant-Jesus, Montreal Neurological Institute and Hospital, Foothills Medical Centre, University Health Network, Toronto, Health Sciences Centre, Winnipeg, Manitoba, Thunder Bay Regional Health Sciences Centre, Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre, Fraser Health, Hopital de Chicoutimi, Université de Sherbrooke
Conditions Intracerebral Hemorrhage
Enrollment 1,456 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov