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Statins In Intracerbral Hemorrhage (SATURN)

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ClinicalTrials.gov Identifier: NCT03936361
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : June 24, 2020
Sponsor:
Collaborators:
NINDS Stroke Trials Network (StrokeNet)
Canadian Stroke Consortium (CSC)
University of Cincinnati
Medical University of South Carolina
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.

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.

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

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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 physicians, 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
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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: June 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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