STATINS USE IN INTRACEREBRAL HEMORRHAGE PATIENTS
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:
• 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
Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Contact Information
Primary
Magdy Selim, MD, PhD
mselim@bidmc.harvard.edu
617-632-8913
Time Frame
Start Date: 2020-06-10
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 1456
Treatments
Active_comparator: Statin
The same statin agent and dose that subjects were using at the time of ICH onset.
No_intervention: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Barnes-Jewish Hospital, University of Florida, University Health Network, Toronto, University of Kansas, University of Minnesota, Sacred Heart Medical Center Springfield, Mount Sinai Hospital, New York, Cedars-Sinai Medical Center, Hopital de Chicoutimi, Hartford Hospital, Prisma Health-Upstate, Johns Hopkins University, St. Joseph's Hospital and Medical Center, Phoenix, Hopital de l'Enfant-Jesus, Milton S. Hershey Medical Center, UMass Memorial Health, NINDS Stroke Trials Network (StrokeNet), University of Arkansas, Huntington Memorial Hospital, Ochsner Health System, Montefiore Medical Center, Long Beach Memorial Medical Center, Augusta University Medical Center, Canadian Stroke Consortium (CSC), Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre, Spectrum Health Hospitals, University of Alabama at Birmingham, Froedtert Hospital, Cox Medical Center South, West Virginia University, Buffalo General Medical Center, University of Southern California, Carolinas Medical Center, Foothills Medical Centre, Scripps Health, Brigham and Women's Hospital, Swedish Medical Center, Arrowhead Regional Medical Center, Oregon Health and Science University, Fraser Health, St. Luke's Hospital, Kansas City, Missouri, Wake Forest University Health Sciences, Columbia University, Staten Island University Hospital, Tufts Medical Center, University of Utah, OSF Healthcare System, MetroHealth Medical Center, Mayo Clinic, Medical University of South Carolina, The University of Texas Health Science Center at San Antonio, McLaren Health Care, University of Louisville, St. Mary's Medical Center, North Shore University Hospital, St. Cloud Hospital, Metro Health, Michigan, Temple University, Tampa General Hospital, Baystate Medical Center, San Francisco General Hospital, University of North Carolina, Chapel Hill, University of Maryland, Baltimore, Legacy Emanuel Medical Center, University of Michigan, Allina Health System, New York Presbyterian Brooklyn Methodist Hospital, Wayne State University, Regions Hospital, OU Medical Center, University of Iowa, University of South Alabama, Eden Medical Center, Health Sciences Centre, Winnipeg, Manitoba, University of Alberta, University of Virginia, Sanford Medical Center Fargo, Central DuPage Hospital, Lehigh Valley Hospital, Weill Medical College of Cornell University, University of Nebraska, Massachusetts General Hospital, Hamilton General Hospital, Université de Sherbrooke, Kaiser Permanente, Yale University, Harborview Injury Prevention and Research Center, The Ottawa Hospital, Tulane Medical Center, The Moses H. Cone Memorial Hospital, Jackson Health System, Stanford University, Rhode Island Hospital, University of Wisconsin, Madison, Mercy San Juan Medical Center, State University of New York - Upstate Medical University, Lahey Hospital & Medical Center, Abington Memorial Hospital, NYU Langone Hospital - Brooklyn, Loyola University, St. David's HealthCare, Desert Care Network, University of Cincinnati, Baylor College of Medicine, Ohio State University, University of Vermont Medical Center, University of New Mexico, University of California, San Diego, Mercy Health Saint Mary Grand Rapids, University of California, Irvine, Thunder Bay Regional Health Sciences Centre, NYU Langone Medical Center - Tisch Hospital, Baptist Medical Center Jacksonville, University of Pittsburgh, Rush University Medical Center, University of Pennsylvania, UH, Cleveland Medical Center, Thomas Jefferson University, University of Kentucky, Intermountain Medical Center, Aurora BayCare Medical Center, Montreal Neurological Institute and Hospital, London Health Sciences Centre, University of California, San Francisco, St. Joseph's Regional Medical Center, New Jersey, York Hospital, York, PA, Banner University Medical Center, George Washington University
Leads: Beth Israel Deaconess Medical Center