StAtins Use in intRacereberal hemorrhage patieNts MRI (SATURN MRI) Ancillary Study - There is a knowledge gap as to whether statins should be used in patients with intracerebral hemorrhage (ICH), in particular patients with lobar ICH who are at high-risk for recurrent ICH. There are no prospective or randomized data on the effects of continuation vs. discontinuation of statins after ICH regarding the risks of ICH recurrence, incidence of cardiovascular events, or long-term functional or cognitive outcomes and quality of life. The SATURN trial (a multi-center, pragmatic, prospective, randomized, open-label, Phase III clinical trial with blinded end-point assessment in patients with lobar ICH taking statins) was recently funded within the NIH/NINDS StrokeNet to address the above uncertainties. We propose an ancillary MRI study (SATURN MRI) which builds on SATURN’s framework. Participants in SATURN will undergo a standardized brain MRI at baseline and at 24 months in order to assess for the presence and burden of markers of cerebral small vessel disease (CSVD) and their progression. The main objective is to determine the effects of continued long-term statin therapy compared to statin discontinuation on the incidence of new hemorrhagic MRI markers of CSVD, namely cerebral microbleeds (CMBs) and cortical superficial siderosis (cSS) on end-study MRI. Secondary objectives are: 1) to assess whether the presence and burden of CMBs and cSS on baseline MRI can be used as an imaging marker to stratify the risk/benefit of statin therapy in patients with lobar ICH; and 2) to evaluate the effects of statin continuation vs. discontinuation on the incidence of new ischemic MRI markers (white matter hyperintensities and covert infarcts) on end-study MRI. This information will be invaluable to complement the interpretation of SATURN’s results. It will provide unique insights on the effect of statins on progression of markers of CSVD, and could lead to validation of MRI imaging markers as tools to assist with individualized decision-making regarding the safety of statins use/continuation in ICH patients and the mitigation of late life cognitive and functional decline. SATURN and SATURN MRI will provide a unique opportunity to simultaneously address important areas in ICH research identified by the NINDS PRG and StrokeNet: 1) prevention of ICH recurrence; and 2) biomarkers that may modify treatment decisions in stroke patients. Furthermore, observations from SATURN MRI could lead to novel hypotheses for further research elucidating the pathogenesis of CSVD implicated in lobar ICH and ultimately lead to novel therapeutic targets aimed at mitigating the progression of microvascular cerebral injury and ensuing disability. These studies have important potential public health and practice implications.
