Brain bleed dilemma: statins – friend or foe?
NCT ID NCT03936361
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 3 trial is testing whether people who have a brain hemorrhage (bleeding stroke) should continue or stop taking their statin medication. The study will follow 1,456 participants for years to see which strategy leads to fewer repeat bleeds or other serious events. It also looks at whether a person's genes (APOE) affect the best choice.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Statins (cholesterol-lowering drugs)
- What this could lead to
- If it works, this could guide doctors on whether to continue or stop statins after a brain hemorrhage, potentially reducing the risk of another bleed or stroke.
- What could go wrong
- This is a large trial, but results may not apply to all patients. Statins have known side effects like muscle pain, and stopping them could increase heart risks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,456 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2020
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beth Israel Deaconess Medical Center
RECRUITINGBoston, Massachusetts, 02215, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Portable MRI could speed up stroke treatment
- Can a herbal formula match traditional medicine for brain bleeds?
- Can a blood marker tell fever from infection in stroke?
- Can blood markers predict brain injury outcomes?
- Can an ancient herbal pill improve outcomes after a bleeding stroke?