Clinical Trial

Statins In Intracerbral Hemorrhage

Study acronym: SATURN
Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2019-05-01; most recent amendment 2026-04-19.
Status change: Not Yet Recruiting → Recruiting 2020-06-22
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 2020-06-10
Primary Completion 2028-12-31 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-21