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New treatment option for Intracerebral Hemorrhage
Official title Statins In Intracerbral Hemorrhage
ClinicalTrials.gov ID: NCT03936361
What this study is testing
What is Statins?
Statins is an investigational medicine, being studied as a potential treatment for intracerebral hemorrhage.
Also referred to as HMG CoA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The SATURN trial aims to determine whether continuation vs. discontinuation of statin drugs after spontaneous lobar intracerebral hemorrhage (ICH) is the best strategy; and whether the decision to continue/discontinue statins should be influenced by an individual's Apolipoprotein-E (APOE) genotype.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
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 can be carried out within 7 days of the onset of the qualifying ICH
- Patient or legally authorized representative, after consultation with the statin prescriber, agrees to be assigned by chance to statin continuation...
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...
- 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
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 can be carried out within 7 days of the onset of the qualifying ICH
- Patient or legally authorized representative, after consultation with the statin prescriber, agrees to be assigned by chance 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.
- 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...
- 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
- Woman of childbearing potential
- Concurrent participation in another research protocol for investigation of experimental therapy.
- Indication that withdrawal of care will be implemented for the qualifying ICH.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, 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, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, 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 ClinicalTrials.gov; the study team decides eligibility.