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StATins Use in intRacerebral hemorrhage patieNts (SATURN)

Award Number: U01NS102289
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: 09/01/2019
PERIOD OF PERFORMANCE END DATE: 02/29/2028

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StATins Use in intRacerebral hemorrhage patieNts (SATURN) - 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 would have significant public health and cost-saving 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: 2026 ( Subtotal = $2,662,380 )
2026	2026	BETH ISRAEL DEACONESS MEDICAL CENTER, INC.	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	6	4/7/2026	NON-COMPETING CONTINUATION	$2,376,186
2026	2026	BETH ISRAEL DEACONESS MEDICAL CENTER, INC.	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	6	4/29/2026	SUPPLEMENT FOR EXPANSION	$2,947
2026	2026	BETH ISRAEL DEACONESS MEDICAL CENTER, INC.	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	6	4/29/2026	SUPPLEMENT FOR EXPANSION	$283,247
														Subtotal = $2,662,380

Issue Date FY: 2025 ( Subtotal = $2,928,100 )
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	5	4/29/2025	NON-COMPETING CONTINUATION	$2,928,100
2025	2024	BETH ISRAEL DEACONESS MEDICAL CENTER, INC.	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	4	12/23/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $2,928,100

Issue Date FY: 2024 ( Subtotal = $558,431 )
2024	2024	BETH ISRAEL DEACONESS MEDICAL CENTER, INC.	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	4	5/14/2024	NON-COMPETING CONTINUATION	$558,431
														Subtotal = $558,431

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	BETH ISRAEL DEACONESS MEDICAL CENTER, INC	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	8/25/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $3,150,398 )
2022	2022	BETH ISRAEL DEACONESS MEDICAL CENTER, INC	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	3	8/10/2022	NON-COMPETING CONTINUATION	$0
2022	2022	BETH ISRAEL DEACONESS MEDICAL CENTER, INC	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	4/29/2022	NON-COMPETING CONTINUATION	$3,150,398
														Subtotal = $3,150,398

Issue Date FY: 2021 ( Subtotal = $3,398,290 )
2021	2021	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	5/25/2021	NON-COMPETING CONTINUATION	$3,398,290
														Subtotal = $3,398,290

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	BETH ISRAEL DEACONESS MEDICAL CENTER, INC	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	6/15/2020	NEW	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $3,014,650 )
2019	2019	BETH ISRAEL DEACONESS MEDICAL CENTER, INC	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	1	9/10/2019	NEW	$0
2019	2019	BETH ISRAEL DEACONESS MEDICAL CENTER, INC	330 BROOKLINE AVE	BOSTON	MA	02215	SUFFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	8/29/2019	NEW	$3,014,650
														Subtotal = $3,014,650

Grand Total All Awards = $15,712,249

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StATins Use in intRacerebral hemorrhage patieNts (SATURN)

Award Number: U01NS102289

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: 09/01/2019

PERIOD OF PERFORMANCE END DATE: 02/29/2028

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