Statins use in ICH Patients (SATURN)

What is the Purpose of this Study?

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.


Eligibility

  • 1. Age ≥ 50 years.
  • 2. Spontaneous lobar ICH confirmed by CT or MRI scan
  • 3. Patient was taking a statin drug at the onset of the qualifying/index ICH
  • 4. Randomization can be carried out within 7 days of the onset of the qualifying ICH
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

STATINS USE IN INRACEREBRAL HEMORRHAGE PATIENTS

Study Details
Disease Type/Condition

Stroke

Principal Investigator

Ayodele, Maranatha

Co-Investigators

Shlee Song

Age Group

Adult

Phase

III

IRB Number

STUDY00000498

ClinicalTrials.gov ID

NCT03936361

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Stroke

Principal Investigator

Ayodele, Maranatha

Age Group

Adult

Phase

III

IRB Number

SATURN

ClinicalTrials.gov ID

NCT03936361

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org