# StATins Use in intRacerebral hemorrhage patieNts (SATURN)

> **NIH NIH U01** · BETH ISRAEL DEACONESS MEDICAL CENTER · 2022 · $3,150,398

## Abstract

There is a knowledge gap and clinical equipoise as to whether statins should be used in patients at high risk
for intracerebral hemorrhage (ICH), in particular patients with lobar ICH who are at high risk for recurrent ICH.
While the benefits of statins in reducing major adverse cerebro-cardio-vascular events (MACCE) are well
established, statins have been linked to a slight increase in the incidence of ICH, particularly in lobar ICH
patients who have Apolipoprotein E ε2 and/or ε4 genotypes, and the presence/number of microbleeds on
gradient-echo MRI. There are no prospective or randomized data on the effects of continuation vs.
discontinuation of statins after ICH regarding the risks of ICH recurrence and incidence of MACCE, or long-
term functional or cognitive outcomes, or quality of life. We propose a multi-center, pragmatic, prospective,
randomized, open-label, Phase III clinical trial with blinded end-point assessment (PROBE) in patients with
lobar ICH taking statins to determine whether continuation or discontinuation of these drugs is the best
strategy. We specifically wish to evaluate the effects of discontinuing vs. continuing statins on the risk of
recurrent symptomatic ICH, and the occurrence of 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) during 24
months of follow-up in patients presenting with lobar ICH while taking a statin. We will also examine: 1) quality
of life, functional, and cognitive outcomes in patients in whom statins are continued vs. discontinued, by
repeated assessments of the EQ-5D quality of life questionnaire, modified Rankin Scale, and Telephone
Montreal Cognitive Assessment at 3, 6, 9, 12, 18, and 24 months; and 2) whether the presence vs. absence of
APOE ε2 and/or ε4 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 statins-treated patients).
We hypothesize that: 1) discontinuation of statins in patients with lobar ICH is likely associated with reduced
risk of ICH recurrence; and 2) patients with lobar ICH and APOE ε2 and/or ε4 genotypes have an increased
risk of recurrent ICH with continuation of statins therapy; and that avoiding statins in this subset of patients with
these biological markers might be helpful to reduce the risk of ICH recurrence.
This proposed study within the NIH StrokeNet will answer an important clinical question relevant to everyday
practice. This study will also 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. Successful studies aiming to prevent ICH and its recurrence
wou...

## Key facts

- **NIH application ID:** 10410577
- **Project number:** 5U01NS102289-03
- **Recipient organization:** BETH ISRAEL DEACONESS MEDICAL CENTER
- **Principal Investigator:** Magdy H Selim
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $3,150,398
- **Award type:** 5
- **Project period:** 2019-09-01 → 2028-02-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10410577

## Citation

> US National Institutes of Health, RePORTER application 10410577, StATins Use in intRacerebral hemorrhage patieNts (SATURN) (5U01NS102289-03). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10410577. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*