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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

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.

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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


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.



Primary Outcome Measures :
  1. Recurrent symptomatic ICH [ Time Frame: within 24 months ]

Secondary Outcome Measures :
  1. Major Adverse Cerebro- and Cardio-Vascular Events [ Time Frame: Within 24 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03936361


Contacts
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Contact: Magdy Selim, MD, PhD 617-632-8913 mselim@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Magdy Selim, MD, PhD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Magdy Selim, Professor of Neurology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03936361    
Other Study ID Numbers: 2018C000515
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: March 15, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases