Intracerebral Hemorrhage Clinical Trial
— SATURNOfficial title:
STATINS USE IN INTRACEREBRAL HEMORRHAGE PATIENTS
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
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 |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05089331 -
ROSE-Longitudinal Assessment With Neuroimaging
|
||
Recruiting |
NCT03605381 -
MORbidity PRevalence Estimate In StrokE
|
||
Active, not recruiting |
NCT04522102 -
Antiplatelet Secondary Prevention International Randomised Trial After INtracerebral haemorrhaGe (ASPIRING)-Pilot Phase
|
Phase 3 | |
Terminated |
NCT04178746 -
PRONTO: Artemis in the Removal of Intraventricular Hemorrhage in the Hyper-Acute Phase
|
||
Not yet recruiting |
NCT03956485 -
Multicentre Registry of Patients With Spontaneous Acute Intracerebral Hemorrhage in Catalonia (HIC-CAT).
|
||
Enrolling by invitation |
NCT02920645 -
Multicenter Validation of the AVICH Score
|
N/A | |
Recruiting |
NCT02625948 -
Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign
|
Phase 2 | |
Completed |
NCT02478177 -
Addressing Real-world Anticoagulant Management Issues in Stroke
|
||
Completed |
NCT01971359 -
Clinical Outcomes Following Parafascicular Surgical Evacuation of Intracerebral Hemorrhage: A Pilot Study
|
N/A | |
Completed |
NCT01261091 -
Early Tracheostomy in Ventilated Stroke Patients
|
N/A | |
Terminated |
NCT00990509 -
Albumin for Intracerebral Hemorrhage Intervention
|
Phase 2 | |
Completed |
NCT00716079 -
The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial
|
N/A | |
Recruiting |
NCT00222625 -
rFVIIa in ICH in Patients Treated With Anticoagulants or Anti-Platelets
|
Phase 2 | |
Recruiting |
NCT05095857 -
The Anesthetic Ketamine as Treatment for Patients With Severe Acute Brain Injury
|
Phase 4 | |
Recruiting |
NCT04548596 -
NOninVasive Intracranial prEssure From Transcranial doppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients
|
||
Not yet recruiting |
NCT06429332 -
International Care Bundle Evaluation in Cerebral Hemorrhage Research
|
Phase 4 | |
Recruiting |
NCT05492474 -
Cranial Ultrasound for Prehospital ICH Diagnosis
|
N/A | |
Not yet recruiting |
NCT05502874 -
Multicenter Registry for Assessment of Markers of Early Neurological Deterioration in Primary Intracerebral Hemorrhage
|
||
Recruiting |
NCT04604587 -
MRI-visible Enlarged Perivascular Spaces and the Alteration of Lymphatic Drainage System in CAA
|
Phase 3 | |
Recruiting |
NCT05504941 -
Detection of an Endovascular Treatment Target in Patients With an Acute, Spontaneous Intracerebral Hemorrhage
|
N/A |