|Principal Investigator: Ramesh Grandhi|
|Keywords: ICH , statins||Department: Neurosurgery - Adult|
|IRB Number: 00129067|
|Specialty: Neurology, Neurology, Neurology|
|Sub Specialties: Neuro Critical Care, Neuro Intensive Care, Stroke|
|Recruitment Status: Recruiting|
1. STUDY OBJECTIVES
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 discontinuation vs. continuation of statins on the occurrence
of any of the following major adverse cardiac and cerebrovascular events (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 statins on the risk of these MACCE during the 24
month follow-up period. We hypothesize that discontinuation of statins is likely associated with
an increase in the risk of MACCE.
o To examine quality of life, functional, and cognitive outcomes in participants in whom statins
are continued vs. discontinued, by repeated assessments of the EQ-5D quality of life
questionnaire, modified Rankin Scale (mRS), and Telephone Montreal Cognitive
Assessment (T-MoCA) at 3, 6, 9, 12, 18, and 24 months. We hypothesize that the likelihood
of neurological and functional disability and death are increased with recurrent ICH
compared to most MACCE, and that patients who discontinue statins will achieve better
outcomes than those who continue statins because of reduced risk of ICH recurrence.
These outcomes will be used to aid the assessment of the trade-off between efficacy and
safety outcomes stated above.
o To prospectively examine whether the presence vs. absence of APOE ε4 and APOE ε2
genotypes modifies the effects of statins on the risk of recurrent ICH (i.e., whether APOE
genotype can be used as a biological marker to stratify the risk of ICH recurrence in statinstreated
patients). We hypothesize that patients with lobar ICH and APOE4 or APOE2
genotypes have an increased risk of recurrent ICH with continuation of statins therapy. If this
hypothesis is true, avoiding statins in this subset of lobar ICH patients with these biological
markers might be particularly helpful to reduce the risk of ICH recurrence.