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Statins In Intracerbral Hemorrhage (SATURN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03936361
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : March 15, 2022
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

Tracking Information
First Submitted Date  ICMJE May 1, 2019
First Posted Date  ICMJE May 3, 2019
Last Update Posted Date March 15, 2022
Actual Study Start Date  ICMJE June 10, 2020
Estimated Primary Completion Date June 30, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2019)
Recurrent symptomatic ICH [ Time Frame: within 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2019)
Major Adverse Cerebro- and Cardio-Vascular Events [ Time Frame: Within 24 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Statins In Intracerbral Hemorrhage
Official Title  ICMJE STATINS USE IN INTRACEREBRAL HEMORRHAGE PATIENTS
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Intracerebral Hemorrhage
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: Statin
    The same statin agent and dose that subjects were using at the time of ICH onset.
    Intervention: Drug: Statins
  • 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.
Publications * Szejko N, Kirsch E, Falcone GJ. Genetic determinants of LDL cholesterol and risk of intracerebral haemorrhage. Curr Opin Lipidol. 2021 Aug 1;32(4):244-248. doi: 10.1097/MOL.0000000000000761. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 1, 2019)
1456
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2026
Estimated Primary Completion Date June 30, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 50 years.
  2. Spontaneous lobar ICH confirmed by CT or MRI scan
  3. Patient was taking a statin drug at the onset of the qualifying/index ICH
  4. Randomization can be carried out within 7 days of the onset of the qualifying ICH
  5. Patient or legally authorized representative, after consultation with the statin prescriber, agrees to be randomized to statin continuation (restart) vs. discontinuation

Exclusion Criteria:

  1. 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.
  2. History of recent myocardial infarction (attributed to coronary artery disease) or unstable angina within the previous 3 months
  3. Diabetic patients with history of myocardial infarction or coronary revascularization
  4. History of familial hypercholesterolemia
  5. Patients receiving proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors
  6. Known diagnosis of severe dementia
  7. Inability to obtain informed consent
  8. 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.
  9. Life expectancy of less than 24 months due to co-morbid terminal conditions.
  10. Pre-morbid mRS >3
  11. ICH score >3 upon presentation.
  12. Contraindications to continuation/resumption of statin therapy, such as significant elevations of serum creatinine kinase and/or liver transaminases, and rhabdomyolysis
  13. Woman of childbearing potential
  14. Concurrent participation in another research protocol for investigation of experimental therapy.
  15. Indication that withdrawal of care will be implemented for the qualifying ICH.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Magdy Selim, MD, PhD 617-632-8913 mselim@bidmc.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03936361
Other Study ID Numbers  ICMJE 2018C000515
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Magdy Selim, Beth Israel Deaconess Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Beth Israel Deaconess Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • 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
Investigators  ICMJE Not Provided
PRS Account Beth Israel Deaconess Medical Center
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP