StATins Use in intRacerebral hemorrhage patieNts (SATURN)
Summary
The purpose of this research study is to find out if it is better to continue or discontinue statin drugs in people who had a brain hemorrhage while taking a statin drug.
Statin drugs help prevent heart disease and ischemic stroke. Ischemic strokes are caused by a clot in a blood vessel that blocks blood flow to a part of the brain.
However, statin drugs might increase the risk of having another brain hemorrhage in some people that already had a brain hemorrhage. Many physicians are not sure what to do about using statin drugs after a brain hemorrhage. They are not sure if it is better to continue or stop treatment with a statin drug after a brain hemorrhage.
Some people may have an increased likelihood of having another brain hemorrhage while taking statin drugs. This may be due to people having certain genes. Genes are made up of DNA. DNA contains information that determines in part the traits, such as eye color, height, or disease risk, that are passed on from parent to child. Genes provide an instruction book for making proteins that make a person unique. This “uniqueness” includes a person’s diseases, response to drugs, or other problems.
Having certain Apolipoprotein-E genes might make some people more likely to have another brain hemorrhage while taking statin drugs. This study is also being done to see if you have one of these Apolipoprotein-E genes and to examine whether having these genes actually increases the risk of brain hemorrhage in people who take statin drugs.
Eligibility
Eligible gender: Male, Female, Transgender, Other
Eligible ages: 50 to 100
Inclusion criteria:
1. Age ≥ 50 years.
2. Spontaneous brain hemorrhage confirmed by CT or MRI scan
3. Patient was taking a statin drug at the onset of the brain hemorrhage
4. Randomization must be carried out within 7 days of the brain hemorrhage.
5. Patient or LAR, after consultation with the physicians prescribing statin, agrees to be randomized to statin continuation (restart) vs. discontinuation.
Exclusion criteria:
1. Suspected secondary cause of the brain hemorrhage, such as an underlying vascular abnormality or tumor, trauma, venous infarction, or hemorrhagic transformation of an ischemic infarct.
2. History of recent heart attach (attributed to coronary artery disease) or unstable angina within the previous 3 months
3. Diabetic patients with history of heart attach or coronary revascularization
4. History of high cholesterol in your family
5. Patients receiving proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors
6. Known diagnosis of severe dementia
7. Inability to obtain informed consent
8. 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.
9. Life expectancy of less than 24 months due to co-morbid terminal conditions.
10. Pre-morbid mRS >3
11. ICH score >3 upon presentation.
12. Contraindications to continuation/resumption of statin therapy, such as significant elevations of serum creatinine kinase and/or liver transaminases, and rhabdomyolysis
13. Concurrent participation in another research protocol for investigation of experimental therapy.
14. Women of childbearing potential
15. Indication that withdrawal of care will be implemented for the qualifying brain hemorrhage
Participate
Additional information
Contact information
Recruitment is through hospital admission or physician referral only.
Principal investigator:
Eric Smith
Clinical trial:
Yes
REB-ID:
REB18-1744