Clinical Trials

Inclusion Criteria:

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

ELIGIBILITY CRITERIA: Participants in SATURN MRI must meet all of the above eligibility criteria, in addition to:

1- Subject or surrogate provides signed informe consent and opt to participate in the MRI study.

2- Subject has no known contraindications to MRI such as claustrophobia, metal implants, or pacemaker.

Exclusion Criteria:

• Suspected secondary cause for the qualifying intracerebral hemorrhage (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.
• Concurrent participation in another research protocol for investigation of experimental therapy.
• Women of childbearing potential.
• Indication that withdrawal of care will be implemented for the qualifying intracerebral hemorrhage (ICH).