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Use of statins in patients with intracerebral hemorrhage
EU CTIS ID: 2024-511465-11-00
What this study is testing
EFFICACY: To determine the effects of continuation vs. discontinuation of statins on the risk of ICH recurrence during 24 months of follow-up in patients presenting with a spontaneous lobar lCH while taking a statin drug. Specifically, we wish to determine the effects of discontinuing vs. continuing statins on the risk of recurrent symptomatic ICH. We hypothesize that discontinuation of statins in patients with lobar ICH is likely associated with reduced risk of ICH recurrence. SAFETY: To determine the effects of discontinuation vs. continuation of statins on the occurrence of any of the following major adverse cardiac and cerebrovascular 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. We specifically wish to estimate the relative and absolute effects of discontinuing statins on the risk of these MACCE during the 24 month follow-up period. We hypothesize that discontinuation of statins is likely associated with an increase in the risk of MACCE.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 must be carried out within 7 days of the onset of the qualifying ICH
- Patient or LAR, after consultation with the physicians prescribing statin, agrees to be randomized to statin continuation (restart) vs. discontinuation
You likely can't join if
- 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.
- 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
See the full eligibility 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 must be carried out within 7 days of the onset of the qualifying ICH
- Patient or LAR, after consultation with the physicians prescribing statin, agrees to be randomized to statin continuation (restart) vs. discontinuation
- 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.
- 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 ICH.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.