Study for brain hemorrhage patients
Protocol: SITE00000015
Full Title
STATINS USE IN INRACEREBRAL HEMORRHAGE PATIENTS (SATURN)
Description
This study enrolls adults who have had a brain hemorrhage within the last 7 days. The purpose of the study is to learn whether it is better to keep taking or stop taking the medication statin after having a brain bleed.

You will be in this study for about 2 years. You will be contacted by phone, mail, or video call during that time to learn more about how you have been doing. During the study you will be randomly selected to either keep taking your statin medication or to stop taking it. Study takes place at Buffalo General Medical Center/Gates Vascular Institute.

Technical Description

PRIMARY AIMS: EFFICACY - To determine the effects of continuation vs. discontinuation of statins on the risk of ICH recurrence during 24 months of follow-up in patients presenting with a spontaneous lobar lCH while taking a statin drug. Specifically, we wish to determine the effects of discontinuing vs. continuing statins on the risk of recurrent symptomatic ICH. We hypothesize that discontinuation of statins in patients with lobar ICH is likely associated with reduced risk of ICH recurrence.SAFETY - To determine the effects of continuation vs. discontinuation of statins on the occurrence of any of the following MACCE (symptomatic ischemic stroke, symptomatic myocardial infarction, newly symptomatic arterial occlusive disease (peripheral, retinal, or carotid), revascularization procedures for coronary, carotid, or peripheral arterial disease, and vascular death). We specifically wish to estimate the relative and absolute effects of discontinuing vs. continuing statins on the occurrence of these MACCE during the 24 months follow-up period. We hypothesize that discontinuation of statins is likely associated with an increase in the risk of MACCE. Site For SATURN
Compensation: No
Eligibility
Adults ages 50+.
Have had bleeding in the brain (brain hemorrhage) within the last 7 days.
Were taking a statin drug.
People who may be eligible for this study will be contacted by study staff directly. Eligible participants will be inpatients of Buffalo General/Gates Vascular Institute.
Age Group: Adults
ClinicalTrials.gov: Open Study
Want to Learn More?
Let us know how the study team can reach you. If you do not hear back within 2 business days, reach out to the study team directly at the contact information above or email ctsiresearch@buffalo.edu and someone will assist you.
Thank you for your interest. This study has restricted recruiting for participants and is not accepting inquiries at this time. If you are interested in learning more about research at UB contact ctsiresearch@buffalo.edu.