Statins In Intracerbral Hemorrhage
ConditionIntracerebral Hemorrhage
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorBeth Israel Deaconess Medical Center
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Statins
Treatment groups
1,456 Participants
are divided into 2 treatment groupsSponsors and collaborators
Beth Israel Deaconess Medical Center
Lead sponsor
NINDS Stroke Trials Network (StrokeNet)
Collaborator
Canadian Stroke Consortium (CSC)
Collaborator
University of Cincinnati
Collaborator
Medical University of South Carolina
Collaborator
Yale University
Collaborator
MetroHealth Medical Center
Collaborator
UH, Cleveland Medical Center
Collaborator
Corewell Health West
Collaborator
West Virginia University
Collaborator
Columbia University
Collaborator
Weill Medical College of Cornell University
Collaborator
New York Presbyterian Brooklyn Methodist Hospital
Collaborator
Buffalo General Medical Center
Collaborator
State University of New York - Upstate Medical University
Collaborator
St. Joseph's Regional Medical Center, New Jersey
Collaborator
Tufts Medical Center
Collaborator
Massachusetts General Hospital
Collaborator
UMass Memorial Health
Collaborator
Brigham and Women's Hospital
Collaborator
Baystate Medical Center
Collaborator
University of Vermont Medical Center
Collaborator
Lahey Hospital & Medical Center
Collaborator
Augusta University Medical Center
Collaborator
Prisma Health-Upstate
Collaborator
The Moses H. Cone Memorial Hospital
Collaborator
University of Virginia
Collaborator
George Washington University
Collaborator
University of Maryland, Baltimore
Collaborator
Mount Sinai Hospital, New York
Collaborator
NYU Langone Medical Center - Tisch Hospital
Collaborator
Montefiore Medical Center
Collaborator
NYU Langone Hospital - Brooklyn
Collaborator
Froedtert Hospital
Collaborator
Central DuPage Hospital
Collaborator
Rush University Medical Center
Collaborator
Loyola University
Collaborator
Stanford University
Collaborator
Mercy San Juan Medical Center
Collaborator
Oregon Health and Science University
Collaborator
Kaiser Permanente
Collaborator
University of Southern California
Collaborator
Cedars-Sinai Medical Center
Collaborator
University of New Mexico
Collaborator
Long Beach Memorial Medical Center
Collaborator
University of California, Irvine
Collaborator
Arrowhead Regional Medical Center
Collaborator
Huntington Memorial Hospital
Collaborator
Scripps Health
Collaborator
University of California, San Diego
Collaborator
Ochsner Health System
Collaborator
St. Joseph's Hospital and Medical Center, Phoenix
Collaborator
Desert Care Network
Collaborator
Eden Medical Center
Collaborator
San Francisco General Hospital
Collaborator
University of California, San Francisco
Collaborator
University of Louisville
Collaborator
Ohio State University
Collaborator
University of Iowa
Collaborator
Sanford Medical Center Fargo
Collaborator
University of Nebraska
Collaborator
Tampa General Hospital
Collaborator
University of Florida
Collaborator
Jackson Health System
Collaborator
Mayo Clinic
Collaborator
Baptist Medical Center Jacksonville
Collaborator
Wayne State University
Collaborator
University of Michigan
Collaborator
Mercy Health Saint Mary Grand Rapids
Collaborator
Metro Health, Michigan
Collaborator
University of Kentucky
Collaborator
McLaren Health Care
Collaborator
Regions Hospital
Collaborator
Allina Health System
Collaborator
University of Kansas
Collaborator
University of Minnesota
Collaborator
St. Cloud Hospital
Collaborator
Milton S. Hershey Medical Center
Collaborator
Abington Memorial Hospital
Collaborator
Temple University
Collaborator
University of Pennsylvania
Collaborator
Lehigh Valley Hospital
Collaborator
York Hospital, York, PA
Collaborator
Thomas Jefferson University
Collaborator
University of Pittsburgh
Collaborator
St. David's HealthCare
Collaborator
Baylor College of Medicine
Collaborator
Tulane Medical Center
Collaborator
The University of Texas Health Science Center at San Antonio
Collaborator
OU Medical Center
Collaborator
University of Utah
Collaborator
Swedish Medical Center
Collaborator
St. Mary's Medical Center
Collaborator
Banner University Medical Center
Collaborator
Intermountain Medical Center
Collaborator
Legacy Emanuel Medical Center
Collaborator
Sacred Heart Medical Center Springfield
Collaborator
Harborview Injury Prevention and Research Center
Collaborator
University of Wisconsin, Madison
Collaborator
Aurora BayCare Medical Center
Collaborator
Wake Forest University Health Sciences
Collaborator
University of Alabama at Birmingham
Collaborator
University of South Alabama
Collaborator
Carolinas Medical Center
Collaborator
Barnes-Jewish Hospital
Collaborator
St. Luke's Hospital, Kansas City, Missouri
Collaborator
University of Arkansas
Collaborator
OSF Healthcare System
Collaborator
Cox Medical Center South
Collaborator
North Shore University Hospital
Collaborator
Rhode Island Hospital
Collaborator
Hartford Hospital
Collaborator
Staten Island University Hospital
Collaborator
Johns Hopkins University
Collaborator
University of North Carolina, Chapel Hill
Collaborator
University of Alberta
Collaborator
The Ottawa Hospital
Collaborator
London Health Sciences Centre
Collaborator
Hamilton General Hospital
Collaborator
Hopital de l'Enfant-Jesus
Collaborator
Montreal Neurological Institute and Hospital
Collaborator
Foothills Medical Centre
Collaborator
University Health Network, Toronto
Collaborator
Health Sciences Centre, Winnipeg, Manitoba
Collaborator
Thunder Bay Regional Health Sciences Centre
Collaborator
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre
Collaborator
Fraser Health
Collaborator
Hopital de Chicoutimi
Collaborator
Université de Sherbrooke
Collaborator
Source ClinicalTrials.gov