Statins In Intracerbral Hemorrhage

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.

Conditions

• Intracerebral Hemorrhage

Interventions

DRUG

Statins

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

Sponsors & Collaborators

• NINDS Stroke Trials Network (StrokeNet)

  collaborator OTHER

• Canadian Stroke Consortium (CSC)

  collaborator OTHER

• University of Cincinnati

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• Yale University

  collaborator OTHER

• MetroHealth Medical Center

  collaborator OTHER

• UH, Cleveland Medical Center

  collaborator UNKNOWN

• Corewell Health West

  collaborator OTHER

• West Virginia University

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Weill Medical College of Cornell University

  collaborator OTHER

• New York Presbyterian Brooklyn Methodist Hospital

  collaborator OTHER

• Buffalo General Medical Center

  collaborator UNKNOWN

• State University of New York - Upstate Medical University

  collaborator OTHER

• St. Joseph's Regional Medical Center, New Jersey

  collaborator OTHER

• Tufts Medical Center

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• UMass Memorial Health

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• Baystate Medical Center

  collaborator OTHER

• University of Vermont Medical Center

  collaborator OTHER

• Lahey Hospital & Medical Center

  collaborator OTHER

• Augusta University Medical Center

  collaborator UNKNOWN

• Prisma Health-Upstate

  collaborator OTHER

• The Moses H. Cone Memorial Hospital

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• George Washington University

  collaborator OTHER

• University of Maryland, Baltimore

  collaborator OTHER

• Mount Sinai Hospital, New York

  collaborator OTHER

• NYU Langone Medical Center - Tisch Hospital

  collaborator UNKNOWN

• Montefiore Medical Center

  collaborator OTHER

• NYU Langone Hospital - Brooklyn

  collaborator UNKNOWN

• Froedtert Hospital

  collaborator OTHER

• Central DuPage Hospital

  collaborator OTHER

• Rush University Medical Center

  collaborator OTHER

• Loyola University

  collaborator OTHER

• Stanford University

  collaborator OTHER

• Mercy San Juan Medical Center

  collaborator UNKNOWN

• Oregon Health and Science University

  collaborator OTHER

• Kaiser Permanente

  collaborator OTHER

• University of Southern California

  collaborator OTHER

• Cedars-Sinai Medical Center

  collaborator OTHER

• University of New Mexico

  collaborator OTHER

• Long Beach Memorial Medical Center

  collaborator OTHER

• University of California, Irvine

  collaborator OTHER

• Arrowhead Regional Medical Center

  collaborator OTHER

• Huntington Memorial Hospital

  collaborator OTHER

• Scripps Health

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• Ochsner Health System

  collaborator OTHER

• St. Joseph's Hospital and Medical Center, Phoenix

  collaborator OTHER

• Desert Care Network

  collaborator UNKNOWN

• Eden Medical Center

  collaborator UNKNOWN

• San Francisco General Hospital

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• University of Louisville

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• University of Iowa

  collaborator OTHER

• Sanford Medical Center Fargo

  collaborator UNKNOWN

• University of Nebraska

  collaborator OTHER

• Tampa General Hospital

  collaborator OTHER

• University of Florida

  collaborator OTHER

• Jackson Health System

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• Baptist Medical Center Jacksonville

  collaborator UNKNOWN

• Wayne State University

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• Mercy Health Saint Mary Grand Rapids

  collaborator UNKNOWN

• Metro Health, Michigan

  collaborator OTHER

• University of Kentucky

  collaborator OTHER

• McLaren Health Care

  collaborator OTHER

• Regions Hospital

  collaborator OTHER

• Allina Health System

  collaborator OTHER

• University of Kansas

  collaborator OTHER

• University of Minnesota

  collaborator OTHER

• St. Cloud Hospital

  collaborator UNKNOWN

• Milton S. Hershey Medical Center

  collaborator OTHER

• Abington Memorial Hospital

  collaborator OTHER

• Temple University

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• Lehigh Valley Hospital

  collaborator OTHER

• York Hospital, York, PA

  collaborator OTHER

• Thomas Jefferson University

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• St. David's HealthCare

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• Tulane Medical Center

  collaborator UNKNOWN

• The University of Texas Health Science Center at San Antonio

  collaborator OTHER

• OU Medical Center

  collaborator UNKNOWN

• University of Utah

  collaborator OTHER

• Swedish Medical Center

  collaborator OTHER

• St. Mary's Medical Center

  collaborator OTHER

• Banner University Medical Center

  collaborator OTHER

• Intermountain Medical Center

  collaborator OTHER

• Legacy Emanuel Medical Center

  collaborator UNKNOWN

• Sacred Heart Medical Center Springfield

  collaborator UNKNOWN

• Harborview Injury Prevention and Research Center

  collaborator OTHER

• University of Wisconsin, Madison

  collaborator OTHER

• Aurora BayCare Medical Center

  collaborator OTHER

• Wake Forest University Health Sciences

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• University of South Alabama

  collaborator OTHER

• Carolinas Medical Center

  collaborator OTHER

• Barnes-Jewish Hospital

  collaborator OTHER

• St. Luke's Hospital, Kansas City, Missouri

  collaborator OTHER

• University of Arkansas

  collaborator OTHER

• OSF Healthcare System

  collaborator OTHER

• Cox Medical Center South

  collaborator UNKNOWN

• North Shore University Hospital

  collaborator OTHER

• Rhode Island Hospital

  collaborator OTHER

• Hartford Hospital

  collaborator OTHER

• Staten Island University Hospital

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• University of North Carolina, Chapel Hill

  collaborator OTHER

• University of Alberta

  collaborator OTHER

• The Ottawa Hospital

  collaborator OTHER

• London Health Sciences Centre

  collaborator OTHER

• Hamilton General Hospital

  collaborator UNKNOWN

• Hopital de l'Enfant-Jesus

  collaborator OTHER

• Montreal Neurological Institute and Hospital

  collaborator OTHER

• Foothills Medical Centre

  collaborator OTHER

• University Health Network, Toronto

  collaborator OTHER

• Health Sciences Centre, Winnipeg, Manitoba

  collaborator OTHER

• Thunder Bay Regional Health Sciences Centre

  collaborator OTHER

• Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre

  collaborator OTHER

• Fraser Health

  collaborator OTHER

• Hopital de Chicoutimi

  collaborator UNKNOWN

• Université de Sherbrooke

  collaborator OTHER

• Beth Israel Deaconess Medical Center

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-10

Primary Completion

2028-12-31

Completion

2029-12-31

FDA Drug

Yes

Countries

• United States

Study Locations