RecruitingPhase 3NCT03936361

Statins In Intracerbral Hemorrhage

STATINS USE IN INTRACEREBRAL HEMORRHAGE PATIENTS

Sponsor

Beth Israel Deaconess Medical Center

Enrollment

1,456 participants

Start Date

Jun 10, 2020

Study Type

INTERVENTIONAL

Conditions

Intracerebral Hemorrhage

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.

Eligibility

Min Age: 50 Years

Inclusion Criteria5

Age ≥ 50 years.
Spontaneous lobar ICH confirmed by CT or MRI scan
Patient was taking a statin drug at the onset of the qualifying/index ICH
Randomization can be carried out within 7 days of the onset of the qualifying ICH
Patient or legally authorized representative, after consultation with the statin prescriber, agrees to be randomized to statin continuation (restart) vs. discontinuation

Exclusion Criteria15

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.
History of recent myocardial infarction (attributed to coronary artery disease) or unstable angina within the previous 3 months
Diabetic patients with history of myocardial infarction or coronary revascularization
History of familial hypercholesterolemia
Patients receiving proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors
Known diagnosis of severe dementia
Inability to obtain informed consent
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.
Life expectancy of less than 24 months due to co-morbid terminal conditions.
Pre-morbid mRS >3
ICH score >3 upon presentation.
Contraindications to continuation/resumption of statin therapy, such as significant elevations of serum creatinine kinase and/or liver transaminases, and rhabdomyolysis
Woman of childbearing potential
Concurrent participation in another research protocol for investigation of experimental therapy.
Indication that withdrawal of care will be implemented for the qualifying ICH.