Statins In Intracerbral Hemorrhage

Intracerebral Hemorrhage Clinical Trial

— SATURN  

Official title:

STATINS USE IN INTRACEREBRAL HEMORRHAGE PATIENTS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03936361
• Other study ID #: 2018C000515
• Status: Recruiting
• Phase: Phase 3
• Start date: June 10, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: July 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: Magdy Selim, MD, PhD
• Phone: 617-632-8913
• Email: mselim[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1456
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

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

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (131)

Lead Sponsor

Collaborator

Beth Israel Deaconess Medical Center

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent symptomatic ICH		within 24 months
Secondary	Major Adverse Cerebro- and Cardio-Vascular Events		Within 24 months