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CREST-2 Statistical and Data Coordinating Center - SDCC

Award Number: U01NS080165
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: 03/15/2014
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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CREST-2 Statistical and Data Coordinating Center - SDCC - The broad, long-term objective of this application is to advance primary prevention of stroke in patients at risk for stroke due to atherosclerosis of the carotid artery. One to two percent of adults in the U.S. have asymptomatic atherosclerotic stenosis of the carotid artery exceeding 50% luminal narrowing. Carotid stenosis is often managed either by endarterectomy or stenting. About 100,000 carotid endarterectomies and 40,000 carotid stenting procedures are done each year in the US. Up to 90% of these procedures are done on asymptomatic patients. The findings of trials assessing the efficacy of revascularization begun in the 1980’s and 1990’s that showed efficacy of revascularization are now in question because of improvements in medical therapy to prevent atherosclerosis and atherothrombosis and concurrent improvements in revascularization by endarterectomy and by carotid stenting. To address the question of how best to treat patients with ≥70% carotid bifurcation stenosis to prevent stroke, we are currently completing the first funding cycle for the CREST-2 trials. CREST-2 is a pair of parallel randomized, multicenter trials with the primary aims: 1) to compare the effectiveness of intensive medical management (IMM) vs. carotid endarterectomy plus IMM (n=1240), and 2) to compare the effectiveness of IMM vs. carotid stenting plus IMM (n=1240). The primary endpoint is a composite of any stroke or death within 44 days of randomization (periprocedural risk) plus ipsilateral stroke up to 4 years of follow-up. An important secondary endpoint is cognitive function, assessed periodically and by a centralized, standardized computer- aided telephone interview. Endpoints are assessed in a manner blinded to treatment assignment. IMM involves central management of vascular risk factors, including hypertension, diabetes mellitus, cigarette smoking and hyperlipidemia. Primary risk factor therapeutic targets are systolic blood pressure <130 mmHg and a low- density lipoprotein (LDL) cholesterol level of <70 mg/dL. IMM also includes telephone-delivered periodic lifestyle coaching. Preliminary data show that the IMM has significantly favorably improved vascular risk factors across treatment arms. As of October 26, 2020, a total of 70% (1734/2480) of the required patients have been randomized across the US, Canada, and Spain. All procedures are performed only by rigorously credentialed surgeons and interventionists. IMM and revascularization procedures are being successfully delivered. Cross- overs and withdrawal from the study are within design assumptions, and the quality of the data is high. CREST-2 supports a companion ancillary study known as CREST-H (NCT03121209) that tests the cognitive implications of revascularization in patients with hemispheric hypoperfusion. We are requesting support to complete recruitment, complete follow-up of the cohort (2-years after recruitment of last patient), and report study results.


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 = $0 )
2025	2024	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	11	6/5/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $1,158,877 )
2024	2024	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	11	7/26/2024	NON-COMPETING CONTINUATION	$1,158,877
														Subtotal = $1,158,877

Issue Date FY: 2023 ( Subtotal = $1,411,449 )
2023	2023	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	10	9/1/2023	NON-COMPETING CONTINUATION	$1,411,460
2023	2022	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	9	12/1/2022	NON-COMPETING CONTINUATION	$0
2023	2020	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	7	11/21/2022	NON-COMPETING CONTINUATION	-$11
														Subtotal = $1,411,449

Issue Date FY: 2022 ( Subtotal = $1,500,189 )
2022	2022	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	9	9/12/2022	NON-COMPETING CONTINUATION	$1,500,189
2022	2021	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	8	1/12/2022	COMPETING CONTINUATION	$1,319,259
2022	2020	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	7	1/12/2022	NON-COMPETING CONTINUATION	-$1,319,259
														Subtotal = $1,500,189

Issue Date FY: 2021 ( Subtotal = $1,587,333 )
2021	2021	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	8	8/26/2021	COMPETING CONTINUATION	$1,587,333
2021	2020	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	7	8/25/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,587,333

Issue Date FY: 2020 ( Subtotal = $2,088,430 )
2020	2020	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	7	4/3/2020	NON-COMPETING CONTINUATION	$2,088,430
														Subtotal = $2,088,430

Issue Date FY: 2019 ( Subtotal = $1,221,645 )
2019	2019	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	6	3/21/2019	NON-COMPETING CONTINUATION	$1,221,645
														Subtotal = $1,221,645

Issue Date FY: 2018 ( Subtotal = $1,234,462 )
2018	2018	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	5	2/28/2018	NON-COMPETING CONTINUATION	$1,234,462
														Subtotal = $1,234,462

Issue Date FY: 2017 ( Subtotal = $1,212,634 )
2017	2017	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	4	3/10/2017	NON-COMPETING CONTINUATION	$1,091,370
2017	2017	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	4	6/5/2017	NON-COMPETING CONTINUATION	$121,264
														Subtotal = $1,212,634

Issue Date FY: 2016 ( Subtotal = $1,196,146 )
2016	2016	UNIVERSITY OF ALABAMA AT BIRMINGHAM	1530 3rd Avenue South, AB 1170	BIRMINGHAM	AL	35294	JEFFERSON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	3/2/2016	NON-COMPETING CONTINUATION	$1,196,146
														Subtotal = $1,196,146

Issue Date FY: 2015 ( Subtotal = $1,249,046 )
2015	2015	UNIVERSITY OF ALABAMA AT BIRMINGHAM	1530 3rd Avenue South, AB 1170	BIRMINGHAM	AL	35294	JEFFERSON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	3/9/2015	NON-COMPETING CONTINUATION	$1,249,046
														Subtotal = $1,249,046

Issue Date FY: 2014 ( Subtotal = $1,179,308 )
2014	2014	UNIVERSITY OF ALABAMA AT BIRMINGHAM	1530 3rd Avenue South, AB 1170	BIRMINGHAM	AL	35294	JEFFERSON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	3/11/2014	NEW	$1,179,308
														Subtotal = $1,179,308

Grand Total All Awards = $15,039,519

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CREST-2 Statistical and Data Coordinating Center - SDCC

Award Number: U01NS080165

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: 03/15/2014

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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