StATins Use in IntRacerebral Hemorrhage PatieNts
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 20-000743
About this study
The purpose of this study is to determine the effects of continuation vs. discontinuation of statins on the risk of Intracerebral Hemorrhage (ICH) recurrence during 24 months of follow-up in patients presenting with a spontaneous lobar Intracerebral Hemorrhage (lCH) while taking a statin drug. And we will also determine the effects of continuation vs. discontinuation of statins on the occurrence of any of the following major adverse cerebro- and cardio-vascular events (MACCE) (symptomatic ischemic stroke, symptomatic myocardial infarction, newly symptomatic arterial occlusive disease (peripheral, retinal, or carotid), revascularization procedures for coronary, carotid, or peripheral arterial disease, and vascular death).
An ancillary MRI study will be performed in a subset of SATURN participants (n= 894). Participation in the MRI study is optional. Participants will undergo a standardized brain MRI protocol including susceptibility-weighted or gradient-echo T2*-weighted imaging, during hospitalization within 7 days of randomization into SATURN and at the end of the 24-month follow-upperiod.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Jeffrey Peel, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available