Purpose

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

Eligibility

Eligible Ages
Over 50 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
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.
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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 names:
    • 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.

Recruiting Locations

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Contact:
Magdy Selim, MD, PhD

More Details

NCT ID
NCT03936361
Status
Recruiting
Sponsor
Beth Israel Deaconess Medical Center

Study Contact

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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.