1456 Participants Needed

Statins After Stroke

(SATURN Trial)

MS
Overseen ByMagdy Selim, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Beth Israel Deaconess Medical Center
Must be taking: Statins
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 6 JurisdictionsThis treatment is already approved in other countries

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?

Research shows that statins, which are drugs that lower cholesterol, can improve outcomes after a stroke by reducing brain damage and protecting nerve cells. They also help prevent future strokes and heart problems by making blood vessels healthier.710111213

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

You have had a specific type of bleeding in your brain confirmed by a CT or MRI scan.
I agree to possibly restart or stop my statin medication as part of the study.
I am 50 years old or older.
See 2 more

Exclusion Criteria

I am taking PCSK9 inhibitors for my cholesterol.
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
My brain bleed might be due to another health issue like a tumor or injury.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Baseline Testing

Participants undergo baseline testing for APOE genotype and MRI for a subset

1 week
1 visit (in-person)

Treatment

Participants are randomized to either continue or discontinue statin therapy

24 months
Regular follow-up visits

Follow-up

Participants are monitored for recurrent symptomatic ICH or major adverse cerebro-/cardio-vascular events

24 months
Regular follow-up visits

MRI Study (optional)

A subset of participants undergoes a repeat MRI to evaluate effects on cerebral small vessel disease markers

End of follow-up period

What Are the Treatments Tested in This Trial?

Interventions

  • Statins
Trial Overview The SATURN trial is testing whether patients with ICH should keep taking statins or stop them. It also looks into how an individual's APOE genotype might influence this decision. Part of the study includes MRI scans to see how these choices affect brain markers related to small vessel disease and risk of another ICH.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: No-statinActive Control1 Intervention
Subjects will discontinue the statin agent that they were taking at the time of ICH onset. No placebo will be prescribed for these subjects.
Group II: StatinActive Control1 Intervention
The same statin agent and dose that subjects were using at the time of ICH onset.

Statins is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺
Approved in European Union as Statins for:
  • Hypercholesterolemia
  • Prevention of cardiovascular events
  • Primary prevention of coronary heart disease
🇺🇸
Approved in United States as Statins for:
  • Hypercholesterolemia
  • Prevention of cardiovascular events
  • Primary prevention of coronary heart disease
  • Secondary prevention of coronary heart disease
🇨🇦
Approved in Canada as Statins for:
  • Hypercholesterolemia
  • Prevention of cardiovascular events
  • Primary prevention of coronary heart disease
🇯🇵
Approved in Japan as Statins for:
  • Hypercholesterolemia
  • Prevention of cardiovascular events
🇨🇳
Approved in China as Statins for:
  • Hypercholesterolemia
  • Prevention of cardiovascular events
🇨🇭
Approved in Switzerland as Statins for:
  • Hypercholesterolemia
  • Prevention of cardiovascular events

Find a Clinic Near You

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials
872
Recruited
12,930,000+

Regions Hospital

Collaborator

Trials
3
Recruited
1,900+

UMass Memorial Health

Collaborator

Trials
4
Recruited
970+

St. Mary's Medical Center

Collaborator

Trials
4
Recruited
1,700+

NINDS Stroke Trials Network (StrokeNet)

Collaborator

Trials
2
Recruited
1,600+

Canadian Stroke Consortium (CSC)

Collaborator

Trials
4
Recruited
2,500+

University of Cincinnati

Collaborator

Trials
442
Recruited
639,000+

Medical University of South Carolina

Collaborator

Trials
994
Recruited
7,408,000+

Yale University

Collaborator

Trials
1,963
Recruited
3,046,000+

MetroHealth Medical Center

Collaborator

Trials
125
Recruited
22,600+

Published Research Related to This Trial

Statins, known for lowering cholesterol levels, have been shown to significantly reduce the risk of acute ischemic events like myocardial infarction and stroke, highlighting their importance in cardiovascular health.
Recent findings suggest that statins also have direct anti-atherosclerotic effects, improving outcomes in ischemic stroke by reducing carotid plaque vulnerability and enhancing neuroprotection, which may lead to new applications in preventing cardiovascular complications.
Statins in the treatment of acute ischemic stroke.Montecucco, F., Quercioli, A., Mirabelli-Badenier, M., et al.[2019]
A systematic review of 13 randomized trials involving 20,438 participants found that HMG-CoA reductase inhibitors (statins) reduced the risk of stroke by 31%, indicating their efficacy in stroke prevention.
The analysis showed that there were significantly fewer strokes in the treatment group compared to the placebo group, reinforcing the potential of statins to prevent strokes, especially in middle-aged individuals.
Stroke, statins, and cholesterol. A meta-analysis of randomized, placebo-controlled, double-blind trials with HMG-CoA reductase inhibitors.Blauw, GJ., Lagaay, AM., Smelt, AH., et al.[2019]
In a study of 143 patients with nonlacunar middle cerebral artery infarcts, those taking statins prior to their ischemic stroke tended to have smaller infarct volumes, suggesting a potential neuroprotective effect of statins.
Multivariable analysis indicated that statin use, along with patient age and recent transient ischemic attack, was independently associated with smaller infarct sizes, highlighting the importance of statins in stroke management.
Statin use is independently associated with smaller infarct volume in nonlacunar MCA territory stroke.Shook, SJ., Gupta, R., Vora, NA., et al.[2006]

Citations

Statins in the treatment of acute ischemic stroke. [2019]
Stroke, statins, and cholesterol. A meta-analysis of randomized, placebo-controlled, double-blind trials with HMG-CoA reductase inhibitors. [2019]
Statin use is independently associated with smaller infarct volume in nonlacunar MCA territory stroke. [2006]
Pre and Post-stroke Use of Statins Improves Stroke Outcome. [2022]
High-dose lovastatin for acute ischemic stroke: results of the phase I dose escalation neuroprotection with statin therapy for acute recovery trial (NeuSTART). [2022]
Co-medication of statins with contraindicated drugs. [2022]
Statin safety: an overview and assessment of the data--2005. [2022]
Comparative evaluation of the safety and efficacy of HMG-CoA reductase inhibitor monotherapy in the treatment of primary hypercholesterolemia. [2018]
Evaluation of the pharmacokinetics and drug interactions of the two recently developed statins, rosuvastatin and pitavastatin. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Comparative dose efficacy study of atorvastatin versus simvastatin, pravastatin, lovastatin, and fluvastatin in patients with hypercholesterolemia (the CURVES study) [2022]
Outcomes from intracerebral hemorrhage among patients pre-treated with statins. [2019]
[Statins (HMG-CoA reductase inhibitors), cholesterol and stroke]. [2013]
13.United Statespubmed.ncbi.nlm.nih.gov
Neuroprotective effects of statins: evidence from preclinical and clinical studies. [2021]
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