Statins In Intracerbral Hemorrhage (SATURN)

Beth Israel Lahey Health

Status and phase

Enrolling

Phase 3

Conditions

Intracerebral Hemorrhage

Treatments

Drug: Statins

Study type

Interventional

Funder types

Other

Identifiers

NCT03936361

2018C000515

Details and patient eligibility

About

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.

Full 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. A subset of SATURN participants will participate in the optional MRI study, where they will undergo a baseline MRI within 7 days of randomization into SATURN and a repeat MRI at the end of the follow-up period.

Recruitment will take place at ~ 140 sites coordinated through the NIH/NINDS StrokeNet and the Canadian Stroke Consortium.

Enrollment

1,456 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 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
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.