Statins In Intracerbral Hemorrhage (SATURN)

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ClinicalTrials.gov Identifier: NCT03936361

Recruitment Status : Recruiting

First Posted : May 3, 2019

Last Update Posted : July 11, 2023

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View this study on the modernized ClinicalTrials.gov

Sponsor:

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

Spectrum Health Hospitals

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 Medical Center

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

Kaiser Permanente Fontana

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 Medical Center

Legacy Emanuel Medical Center

Sacred Heart Medical Center Springfield

Harborview Injury Prevention and Research Center

University of Wisconsin, Madison

Aurora BayCare Medical Center

Aurora Health Care

University of Alabama at Birmingham

University of South Alabama

Wake Forest University Health Sciences

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

Information provided by (Responsible Party):

Magdy Selim, Beth Israel Deaconess Medical Center

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Intracerebral Hemorrhage	Drug: Statins	Phase 3

Detailed Description:

SATURN is a multi-center, pragmatic, prospective, randomized, open-label, and blinded end-point assessment (PROBE) clinical trial. A total of 1,456 patients presenting within 7 days of a spontaneous lobar ICH while taking statins will be randomized to one of two treatment strategies: discontinuation vs. continuation of statin therapy (using the same agent and dose that they were using at ICH onset). Participating subjects will undergo baseline testing for APOE genotype and will be followed for 24 months to assess for the occurrence of recurrent symptomatic ICH or major adverse cerebro-/cardio-vascular events (MACCE) during the follow-up period. A subset of SATURN participants will participate in the optional MRI study, where they will undergo a baseline MRI within 7 days of randomization into SATURN and a repeat MRI at the end of the follow-up period.

Recruitment will take place at ~ 140 sites coordinated through the NIH/NINDS StrokeNet and the Canadian Stroke Consortium.

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	1456 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	Participants will be randomized at 1:1 ratio to either continue the same statin drug and dosage that they are taking at the time of ICH onset or to discontinue it for up to 24 months after ICH. No placebo will be prescribed for those randomized to discontinue statins.
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	STATINS USE IN INTRACEREBRAL HEMORRHAGE PATIENTS
Actual Study Start Date :	June 10, 2020
Estimated Primary Completion Date :	June 30, 2026
Estimated Study Completion Date :	December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Cholesterol Medicines Statins

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Statin The same statin agent and dose that subjects were using at the time of ICH onset.	Drug: Statins Statin drugs (already prescribed) at ICH onset will be either continued or discontinued by the participants following qualifying ICH Other Name: HMG CoA
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.

Outcome Measures

Primary Outcome Measures :

Recurrent symptomatic ICH [ Time Frame: within 24 months ]

Secondary Outcome Measures :

Major Adverse Cerebro- and Cardio-Vascular Events [ Time Frame: Within 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Layout table for eligibility information

Ages Eligible for Study:	50 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
Patients receiving proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors
Known diagnosis of severe dementia
Inability to obtain informed consent
Patients known or suspected of not being able to comply with the study protocol due to alcoholism, drug dependency, or other obvious reasons for noncompliance, such as unable to adhere to the protocol specified visits/assessments.
Life expectancy of less than 24 months due to co-morbid terminal conditions.
Pre-morbid mRS >3
ICH score >3 upon presentation.
Contraindications to continuation/resumption of statin therapy, such as significant elevations of serum creatinine kinase and/or liver transaminases, and rhabdomyolysis
Woman of childbearing potential
Concurrent participation in another research protocol for investigation of experimental therapy.
Indication that withdrawal of care will be implemented for the qualifying ICH.

Contacts and Locations