Statins use in ICH Patients (SATURN)

Condition: Brain hemorrhage

Eligibility

Key Inclusion Criteria

  • At least 50 years old
  • Spontaneous lobar intracerebral hemorrhage (ICH) confirmed by computed tomography or magnetic resonance imaging scan
  • Patient was taking a statin drug at the onset of the qualifying ICH

Key Exclusion Criteria

  • Suspected secondary cause 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

Full Study Name

Statins Use in Intracerebral Hemorrhage (SATURN) (IRB no. 00000498) 

Summary

This study focuses on individuals who have had a brain hemorrhage and were taking a statin drug (a drug that is used to reduce cholesterol level in the blood). Brain hemorrhage is a type of stroke that occurs when a blood vessel in part of the brain bursts open. The purpose of the study is to determine whether it is better to continue or discontinue statin drugs in patients who had a brain hemorrhage while taking a statin drug. 

Some people may have an increased likelihood of having another brain hemorrhage while taking statin drugs, which may be due to having certain genes. Researchers aim to determine whether study participants have one of these genes (called Apolipoprotein-E genes) and will examine whether having the gene actually increases the risk of brain hemorrhage in those who take statin drugs.

Participants will be randomly assigned to one of two groups. One group will continue taking the same statin drug and dosage that they were taking when the brain hemorrhage occurred without any change (or will restart if it was stopped after hospital admission). The other group will stop taking statin drugs for 2 years.

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