Intracranial Hemorrhage – SATURN

Name:  Statins In Intracerbral Hemorrhage

Contact:  Neringa May (Lead CRC, 352-273-6448), Dr. Anna Khanna (PI)

Enrolling hours:  M-F (8AM-5PM)

Diagnosis: ICH

Inclusion Criteria:

Age ≥ 50 years.

Spontaneous lobar ICH within 7 days prior to randomization confirmed by CT or MRI scan. Lobar ICH will be defined as ICH involving cortical or subcortical locations and situated ≥1 cm from the body of the ipsilateral lateral ventricle and not originating from any of the following deep structures (thalamus, putamen, globus pallidus, caudate, or internal capsule). Patients with superficial cerebellar ICH, particularly in whom MRI shows lobar cerebral microbleeds suggestive of CAA, can be eligible.

Patient was taking a statin drug at the onset of the qualifying/index ICH

Randomization must be carried out within 7 days of the onset of the qualifying ICH

Patient or legally authorized representative, after consultation with physicians, agrees to be randomized to statin continuation (restart) vs. discontinuation.

Exclusion Criteria:

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

Patient 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

Women of childbearing potential, defined as pre-menopausal women capable of becoming pregnant (Post-menopausal women, women who are surgically sterilized, and women who are known to be infertile can be enrolled in the trial).

Concurrent participation in another research protocol for investigation of experimental therapy.

Indication that withdrawal of care will be implemented for the qualifying ICH.