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Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART)

Award Number: R21NS103752
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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SUMMARY/ABSTRACT There has been unprecedented rise in the prevalence of stroke in sub-Saharan Africa (SSA), which when compared to stroke profiles in high-income countries (HIC) is characterized by a younger age of onset, higher case fatality rates, and more severe disability among survivors. Stroke survivors in SSA (vs. HIC) are especially at high risk for recurrent vascular events or death due to undiagnosed or under-controlled vascular risk factors, logistical challenges, low health literacy, and lack of care affordability. While international expert consensus secondary prevention guidelines recommend that antihypertensive, statin and anti-platelet therapy, be initiated promptly after ischemic stroke and adhered to in a persistent fashion to achieve optimal vascular risk reduction, these goals are seldom realized in routine clinical care settings in SSA. A relatively simple, low-cost, evidence- based strategy that could be largely applied in a uniform manner to stroke survivors in low- to –middle income countries (LMICs), including the nations of SSA, is sorely needed. Fixed-dose combination pills, also known as “polypills”, containing generic drugs, i.e. Aspirin, a statin, and blood pressure (BP) lowering medication(s) may be a viable avenue to improve medication adherence and consequently reduce risk of further disability or death on a large scale among stroke survivors encountered in resource-constrained regions. The overarching objective of the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART) trial is to determine the preliminary impact of a polypill (Polycap DS ®) containing fixed doses of antihypertensives, a statin, and antiplatelet therapy taken once daily orally in reducing future vascular risk compared to usual care in 120 recent stroke patients seen at a hospital in Kumasi, Ghana, while preparing for a future large, multicenter pragmatic trial and building local research capacity. In SMAART, we will 1) evaluate whether a polypill-based treatment strategy would result in carotid intimal media thickness stabilization/regression compared with usual care among recent stroke patients at one year after an index ischemic stroke; 2) assess whether a polypill-based treatment strategy improves vascular risk reduction drug adherence and tolerability, as well as blood pressure and serum holesterol control targets, compared with usual care among recent stroke patients at one year after an index ischemic stroke; and 3) provide increased capacity for conducting clinical research and continuous mentorship to early stage career investigators in Ghana, and facilitate their transition to independent investigators capable of planning and executing rigorous randomized controlled for secondary stroke prevention and vascular risk reduction in a resource-limited setting. A preliminarily feasible and efficacy-suggesting SMAART trial will inform the design of a future multi-center, double-blinded, placebo-controlled, randomized trial comparing the clinical efficacy of the polypill strategy vs ‘usual care’ in the African context to derive locally relevant, high-quality evidence for routine deployment of the polypill strategy for vascular risk moderation among stroke survivors in LMICs.


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: 2023 ( Subtotal = $0 )
2023	2019	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST # 151	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	10/11/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST 151 NC	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	10/19/2020	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2021	2019	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST 151 NC	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	2	2/25/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2021	2019	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST 151 NC	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	2	9/20/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST 151 NC	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	2	11/19/2019	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$155,406
2020	2019	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST 151 NC	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	004	2	12/26/2019	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2020	2019	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST 151 NC	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	003	2	11/19/2019	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$5,000
2020	2017	MEDICAL UNIVERSITY OF SOUTH CAROLINA THE	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	1	11/19/2019	NEW	-$5,000
2020	2017	MEDICAL UNIVERSITY OF SOUTH CAROLINA THE	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	11/19/2019	NEW	-$155,406
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $147,022 )
2019	2019	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST 151 NC	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	003	2	9/24/2019	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$147,022
2019	2019	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST 151 NC	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	2	9/23/2019	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$147,022
2019	2019	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST 151 NC	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	8/6/2019	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$147,022
2019	2017	MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	1	8/7/2019	NEW	$0
														Subtotal = $147,022

Issue Date FY: 2018 ( Subtotal = $0 )
2018	2017	MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	9/5/2018	NEW	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $160,406 )
2017	2017	MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	1	9/22/2017	NEW	$0
2017	2017	MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	7/17/2017	NEW	$160,406
														Subtotal = $160,406

Grand Total All Awards = $307,428

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Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART)

Award Number: R21NS103752

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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