What is the Purpose of this Study?
This study focuses on individuals who have had a brain hemorrhage and were taking a statin drug (a drug that is used to reduce cholesterol level in the blood). Brain hemorrhage is a type of stroke that occurs when a blood vessel in part of the brain bursts open. The purpose of the study is to determine whether it is better to continue or discontinue statin drugs in patients who had a brain hemorrhage while taking a statin drug. Some people may have an increased likelihood of having another brain hemorrhage while taking statin drugs, which may be due to having certain genes. Researchers aim to determine whether study participants have one of these genes (called Apolipoprotein-E genes) and will examine whether having the gene actually increases the risk of brain hemorrhage in those who take statin drugs. Participants will be randomly assigned to one of two groups. One group will continue taking the same statin drug and dosage that they were taking when the brain hemorrhage occurred without any change (or will restart if it was stopped after hospital admission). The other group will stop taking statin drugs for 2 years.
Eligibility
- 1. Age ≥ 50 years.
- 2. Spontaneous lobar ICH confirmed by CT or MRI scan
- 3. Patient was taking a statin drug at the onset of the qualifying/index ICH
- 4. Randomization can be carried out within 7 days of the onset of the qualifying ICH
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Inclusion Criteria:
- 1. Age ≥ 50 years.
- 2. Spontaneous lobar ICH confirmed by CT or MRI scan
- 3. Patient was taking a statin drug at the onset of the qualifying/index ICH
- 4. Randomization can be carried out within 7 days of the onset of the qualifying ICH
- 5. Patient or legally authorized representative, after consultation with the statin prescriber, agrees to be randomized to statin continuation (restart) vs. discontinuation
Exclusion Criteria:
- 1. 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.
- 2. History of recent myocardial infarction (attributed to coronary artery disease) or unstable angina within the previous 3 months
- 3. Diabetic patients with history of myocardial infarction or coronary revascularization
- 4. History of familial hypercholesterolemia
- 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. Woman of childbearing potential
- 14. Concurrent participation in another research protocol for investigation of experimental therapy.
- 15. Indication that withdrawal of care will be implemented for the qualifying ICH.
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Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
STATINS USE IN INRACEREBRAL HEMORRHAGE PATIENTS