Actively Recruiting

Phase 3
Age: 50Years +
All Genders
NCT03936361

Statins In Intracerbral Hemorrhage

Led by Beth Israel Deaconess Medical Center · Updated on 2026-04-21

1456

Participants Needed

1

Research Sites

494 weeks

Total Duration

On this page

Sponsors

B

Beth Israel Deaconess Medical Center

Lead Sponsor

N

NINDS Stroke Trials Network (StrokeNet)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Statins In Intracerbral Hemorrhage

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 50 years or older
  • Spontaneous lobar intracerebral hemorrhage confirmed by CT or MRI
  • Taking a statin drug at the time of the qualifying hemorrhage
  • Randomization possible within 7 days of hemorrhage onset
  • Patient or legal representative agrees to randomization to continue or stop statin therapy after consulting with the statin prescriber
Not Eligible

You will not qualify if you...

  • Suspected secondary cause of hemorrhage such as vascular abnormality, tumor, trauma, venous infarction, or hemorrhagic transformation of ischemic stroke
  • Recent myocardial infarction or unstable angina within 3 months
  • Diabetic patients with history of myocardial infarction or coronary revascularization
  • History of familial hypercholesterolemia
  • Use of PCSK9 inhibitors
  • Diagnosis of severe dementia
  • Unable to provide informed consent
  • Known or suspected inability to comply with study protocol due to alcoholism, drug dependency, or other reasons
  • Life expectancy less than 24 months due to terminal conditions
  • Pre-existing modified Rankin Scale score greater than 3
  • Intracerebral hemorrhage score greater than 3 at presentation
  • Contraindications to statin therapy such as elevated creatinine kinase, liver enzymes, or rhabdomyolysis
  • Woman of childbearing potential
  • Participation in another experimental therapy research protocol
  • Indication that withdrawal of care will be implemented for the qualifying hemorrhage

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

M

Magdy Selim, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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