Statins After Stroke
(SATURN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.An MRI ancillary study (SATURN MRI), in a subset of SATURN participants , will evaluate the effects of continuation vs. discontinuation of statin drugs on hemorrhagic and ischemic MRI markers of cerebral small vessel disease, and whether the presence/burden of hemorrhagic markers (i.e. cerebral microbleeds and/or cortical superficial siderosis) on baseline MRI influences the risk of ICH recurrence on/off statin therapy.
Will I have to stop taking my current medications?
The trial specifically looks at whether to continue or stop taking statin drugs after a stroke, so you may need to change your statin use. The protocol does not mention other medications, so it's unclear if you need to stop any other current medications.
Is it safe to use statins in humans?
Statins, which include drugs like atorvastatin, simvastatin, and rosuvastatin, have been studied in many research trials and are generally well tolerated by humans. However, they can sometimes cause side effects, especially on muscles, liver, kidneys, and the nervous system, and should be used carefully, especially when combined with other medications.12345
How do statins differ from other drugs for stroke treatment?
Statins are unique in stroke treatment because they not only lower cholesterol but also provide neuroprotective effects, reducing the risk of further strokes and improving outcomes after an ischemic stroke. They are recommended to be started as soon as possible after a stroke, unlike other treatments that may not have these dual benefits.678910
What data supports the effectiveness of the drug Statins after a stroke?
Are You a Good Fit for This Trial?
This trial is for individuals aged 50 or older who experienced a type of stroke called spontaneous lobar intracerebral hemorrhage (ICH), were taking statins at the time, and can decide within 7 days to continue or stop their statin medication. It's not for those with severe dementia, high ICH scores, recent heart issues, certain muscle/liver conditions, familial cholesterol problems, drug/alcohol dependency, other serious health issues or women who could become pregnant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Testing
Participants undergo baseline testing for APOE genotype and MRI for a subset
Treatment
Participants are randomized to either continue or discontinue statin therapy
Follow-up
Participants are monitored for recurrent symptomatic ICH or major adverse cerebro-/cardio-vascular events
MRI Study (optional)
A subset of participants undergoes a repeat MRI to evaluate effects on cerebral small vessel disease markers
What Are the Treatments Tested in This Trial?
Interventions
- Statins
Statins is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Hypercholesterolemia
- Prevention of cardiovascular events
- Primary prevention of coronary heart disease
- Hypercholesterolemia
- Prevention of cardiovascular events
- Primary prevention of coronary heart disease
- Secondary prevention of coronary heart disease
- Hypercholesterolemia
- Prevention of cardiovascular events
- Primary prevention of coronary heart disease
- Hypercholesterolemia
- Prevention of cardiovascular events
- Hypercholesterolemia
- Prevention of cardiovascular events
- Hypercholesterolemia
- Prevention of cardiovascular events
Find a Clinic Near You
Who Is Running the Clinical Trial?
Beth Israel Deaconess Medical Center
Lead Sponsor
Regions Hospital
Collaborator
UMass Memorial Health
Collaborator
St. Mary's Medical Center
Collaborator
NINDS Stroke Trials Network (StrokeNet)
Collaborator
Canadian Stroke Consortium (CSC)
Collaborator
University of Cincinnati
Collaborator
Medical University of South Carolina
Collaborator
Yale University
Collaborator
MetroHealth Medical Center
Collaborator