SATURN MRI: study protocol for the statin use in intracerebral hemorrhage patients MRI ancillary study

The benefit-risk of statins in patients with lobar intracerebral hemorrhage (ICH) is under investigation in the StATins Use in intRacerebral hemorrhage patieNts (SATURN) trial. The relationship between statin use in ICH survivors, MRI markers of cerebral small vessel disease (CSVD), and outcomes such as recurrent ICH or major adverse cardiovascular or cerebrovascular events (MACCE) is unclear. The ancillary study, SATURN-MRI, intends to evaluate the interrelationship between statin use, the progression of MRI markers of CSVD, and cognitive and functional outcomes. Additionally, SATURN-MRI aims to assess whether baseline MRI markers of CSVD interact with statin continuation for the outcomes of recurrent ICH or MACCE in patients with lobar ICH.

A target of 894 SATURN participants will undergo a baseline MRI within 7 days of randomization and a repeat MRI at the end of the 24-month follow-up period. Any SATURN subject without contraindication to MRI has the option to participate in SATURN MRI. MRIs will be reviewed by blinded central raters to assess for the presence and burden of markers of CSVD and their progression. The primary outcome is new cerebral microbleeds and/or sulci with cortical superficial siderosis identified on T2*-weighted (GRE, SWI or SWAN) images between baseline and end-study MRI. Additional outcomes include the progression of white matter hyperintensity and incidence of covert infarcts.

The results will provide insights about the interrelationship between the effects of statins, progression of MRI markers of CSVD, and functional and cognitive outcomes. They might lead to the validation of MRI markers as tools to assist with individualized decision-making regarding the effects of statins continuation/discontinuation in patients with lobar ICH.

ClinicalTrials.gov NCT03936361. SATURN Trial was originally registered on May 1, 2019 and modified on February 28, 2022.