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StAtins Use in intRacereberal hemorrhage patieNts MRI (SATURN MRI) Ancillary Study

Award Number: U01NS120871
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/15/2021
PERIOD OF PERFORMANCE END DATE: 08/31/2027

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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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $1,144,357 )
2025	2025	BETH ISRAEL DEACONESS MEDICAL CENTER, INC.	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	004	2	9/17/2025	EXTENSION WITH OR WITHOUT FUNDS	$349,956
2025	2025	BETH ISRAEL DEACONESS MEDICAL CENTER, INC.	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	003	2	8/28/2025	SUPPLEMENT FOR EXPANSION	$68,553
2025	2025	BETH ISRAEL DEACONESS MEDICAL CENTER, INC.	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	8/27/2025	EXTENSION WITH OR WITHOUT FUNDS	$650,503
2025	2025	BETH ISRAEL DEACONESS MEDICAL CENTER, INC.	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	2	8/28/2025	SUPPLEMENT FOR EXPANSION	$41,552
2025	2025	BETH ISRAEL DEACONESS MEDICAL CENTER, INC.	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	2	8/28/2025	SUPPLEMENT FOR EXPANSION	$33,793
														Subtotal = $1,144,357

Grand Total All Awards = $1,144,357

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StAtins Use in intRacereberal hemorrhage patieNts MRI (SATURN MRI) Ancillary Study

Award Number: U01NS120871

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/15/2021

PERIOD OF PERFORMANCE END DATE: 08/31/2027

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