The document provides information about the University of Michigan StrokeNet Regional Coordinating Center #17 (RCC-17). It discusses the origins and growth of StrokeNet and RCC-17 over time. Currently, RCC-17 coordinates clinical trials across 17 counties in Michigan and Kentucky, enrolling over 270 sites on average. RCC-17 runs both prevention and treatment trials, enrolling nearly 500 subjects total. It aims to improve enrollment diversity and provides fellowships for training in stroke research. RCC-17 also develops new clinical trial proposals and represents the region in national StrokeNet committees.

1. StrokeNet RCC-17
Successes in Changing Stroke Care…
And Future Opportunities

2. What is NIH StrokeNet?
• National clinical trial network
• Phase 1 through 3 Trials AND Biomarker studies
• Focus on:
• Stroke Prevention
• Acute Stroke Treatment
• Post-Stroke Recovery
• NIH: “All clinical stroke trials will be done through StrokeNet.”
• Centralized contracts, cIRB, data management, trial operations
• Uses standard RO1 format with network input

3. Where Did StrokeNet Start?
• 1992 – UM Division of Emergency Medicine
• First Neuroprotective Trial (RANTAAS, tirilazad mesylate)
• 1995 – NINDS tPA Trial Published (NEJM)
• tPA treatment for stroke led by EM Faculty
• Early endovascular trials (PROACT-2, prourokinase)
• New EM stroke-oriented faculty (Silbergleit, Meurer)
• 2002 – UM Stroke Program
• Drs. Lewis Morgenstern and Devin Brown
• Multidisciplinary acute stroke response (Sozener, Mamer)
• 2005 – Expanding ED use of tPA in stroke: INSTINCT Trial (RO1)
• 2013 – NIH StrokeNet (U10, U24,… U24)

4. National Geographic Coverage
• NCC – Univ of Cincinnati
• DMC - MUSC
• RCCs – 24 current, 3
legacy

5. RCC-17
Geographic
Coverage

6. RCC-17 Population Demographics
Table 1. 2021 UM RCC Network Service Area Population, by County and Race / Ethnicity*,
**
County Total Population White % Black % Asian % Hispanic %
Wayne, MI 1,774,816 970,824 55% 681,529 38% 63,893 4% 115,363 7%
Oakland, MI 1,270,017 952,513 75% 176,532 14% 106,681 8% 59,691 5%
Macomb, MI 876,792 692,666 79% 116,613 13% 40,332 5% 25,427 3%
Jefferson, KY 777,874 551,513 71% 177,355 23% 25,670 3% 51,340 7%
Kent, MI 658,046 538,282 82% 70,411 11% 22,374 3% 74,359 11%
Genesee, MI 404,208 303,156 75% 82,054 20% 4,446 1% 15,764 4%
Washtenaw, MI 369,396 274,461 74% 45,066 12% 33,984 9% 19,209 5%
Fayette, KY 321,793 245,850 76% 51,165 16% 13,837 4% 24,134 8%
Dauphin, PA 287,400 201,755 70% 55,181 19% 18,394 6% 30,752 11%
Ingham, MI 284,034 215,014 76% 35,504 13% 18,462 7% 23,291 8%
Kalamazoo, MI 261,670 211,691 81% 30,877 12% 7,327 3% 14,654 6%
Saginaw, MI 189,591 143,900 76% 36,781 19% 2,465 1% 17,442 9%
Bay, MI 102,985 97,115 94% 2,060 2% 618 1% 5,973 6%
Grand Traverse, MI 95,860 91,076 95% 863 1% 767 1% 3,068 4%
Emmett, MI 34,225 31,521 92% 274 1% 205 1% 753 2%
TOTAL 7,780,716 5,521,335 72% 1,562,266 20% 359,456 5% 481,219 6%
*US Census Bureau Data, Population Estimates July 1, 2021, https://www.census.gov/quickfacts/fact/table/US/PST045221
**Less than 1% population in Native American/Alaskan native and native Hawaiian or Pacific Islander

8. RCC-17 Current Clinical Trials
• ARCADIA (Joe Carrera, UM PI, Prevention)
• ARCADIA-CSI (Joe Carrera, UM PI, Prevention)
• ASPIRE (Aditya Pandey, UM PI, Prevention; Apixiban vs ASA post AF ICH)
• CAPTIVA (NEW, AC vs Anti-platelet theray for IC atherosclerosis)
• CREST-2 (Nick Osborne, UM PI, Prevention, med tx vs comb w stent/revas in asymp CA dz)
• TRANSPORT2 (TC DC Stimulation for stroke rehab; UK)
• I-ACQUIRE (Jessica Pruente, UM PI, Pediatric stroke rehab)
• MOST (Cemal Sozener, UM PI, Acute treatment; tPA+2b3A inhib/DTI)
• FASTEST (NEW, Acute treatment; early rFVIIa for ICH)
• SATURN (Aditya Pandey, UM PI; Statins in ICH prevention)
• SLEEPSMART (Devin Brown, National PI)
• VERIFY (NEW, Chandramouli Krishnan, UM PI, Biomarker validation)
• ASPIRE (Aditya Pandey, UM PI)

9. RCC-17 Enrollment & Performance
Table 2. NDMC StrokeNet Clinical Trial Enrollment Data & Performance Metrics (and Other Allowed NIH Trials)
Trial
Name
Enrolling
Sites
(n)
Average days to
site activation
(min, max)
Average days to
first subject
randomized
(min, max)
Total
randomized
(n)
Average monthly
randomized rate
(min, max)
Total enrolled
(consented)*
Average
retention
rate
(%)
Average
percentage of CRFs
submitted within
window
ARCADIA2 9 171 (92, 352) 75 (29, 170) 64 0.21 (0.13, 0.42) 191 82.8 83.5 %
ARCADIA-CSI2 6 152 (71, 251) 84 (15, 199) 16 0.12 (0.06, 0.22) 16 93.7 76.4 %
I-ACQUIRE3,6 1 201 (201, 201) 2 (2, 2) 9 0.28 (0.28, 0.28) 9 100.0 36.5 %
Sleep SMART2 9
352
(131, 1275)
76
(12, 182)
33 0.18 (0.06, 0.34) 101 87.8 84.0 %
TRANSPORT23 1 87 (87, 87) 244 (244, 244) 2 0.09 (0.09, 0.09) 2 100.0 83.2 %
MOST1 5 414 (331, 560) 223 (9, 600) 37 0.25 (0.07, 0.45) 37 89.1 82.8 %
ASPIRE2 7 322 (195, 707) 659 (356, 833) 3 0.04 (0.03, 0.06) 3 100.0 69.2 %
SATURN2 6 247 (125, 334) 208 (50, 485) 14 0.1 (0.03, 0.32) 14 100.0 80.0 %
SATURN-MRI2 2 0 0
VERIFY,7 1 307 (307, 307) 77 (77, 77) 2 0.39 (0.39, 0.39) 2 100.0 71.4 %
CAPTIVA3 2 350 (316, 384) 6 (6, 6) 1 0.27 (0.27, 0.27) 1 NA 94.1 %
DEFUSE31 1 15 (15, 15) 4 0.45 (0.45, 0.45) 4 76.4 %
CREST23 7 88 88
CREST-H3 7 6 6
StrokeNet
Summary
17
271
(71, 1275)
161
(2, 833)
279
0.18
(0.03, 0.45)
474 92.6 % 81.0 %
1-Acute Treatment Trial, 2-Prevention Trial, 3-Recovery/Rehab Trial, 4-Observational Studies, 5-NIH COVID Trial, 6-Pediatric Trial, 7-Biomarker Trial.
*Only available for studies that has a two-step process for enrolling subjects into the trial/study
Data as of January 17, 2023. ** DIVERSE VCID achieved 93% Black/African American participation. StrokeNet Data from NDMC.

11. RCC-17 Enrollment Diversity
• Female 48.2%
• Non-White 19.2%
• Hispanic 1.8%

12. RCC-17 StrokeNet Fellowship
Grant YR Trainee Name Background
Currently
in
academics
Currently
engaged in
stroke
research
Abstracts
from
trainee YR
(n)
Published
papers
from
trainee YR
(n)
Grants
1 (U10 #1) Jonggyu Baek, PhD Biostatistics Yes Yes 2 6
2 (U10 #2)
Cemal Sozener, MD,
MEng
Emergency
Medicine
Yes Yes 2 4
3 (U10 #3)
Natalie Wheeler, JD,
MD*
Vascular
Neurology
Yes Yes 2 1
4-5 (U10 #4-
5)
Chengwei Li, MPH Epidemiology Yes Yes 4 2
7-8 (U24 #2-
3)
Liming Dong, PhD* Epidemiology Yes Yes 7 5 2 R03’s
9 (U24 #4) Leanna Delhey,
PhD*,#
Epidemiology Yes Yes 3 2
AHA postdoc
fellowship
10 (U24 #5)
(current)
Chris Becker, MD,
MA
Vascular
Neurology
Yes Yes NA NA
10 (U24 #5)
(current)
Lauren Mamer, MD,
PhD*
Emergency
Medicine
Yes Yes NA NA

13. RCC-17 Clinical Trial Proposal Development
 Sleep for Stroke Management And Recovery Trial (Sleep SMART): Dr. Devin Brown, M-PI Michigan
StrokeNet, and Dr. Ronald Chervin are M-PIs of this phase 3 stroke prevention trial with an embedded
recovery trial using continuous positive airway pressure. Sleep SMART is 35% of the way through
recruitment and is approaching the single interim analysis time point.
 STEP: A Platform Trial for Stroke Thrombectomy: (J. Elm, contact PI, MUSC). Dr. Scott will co-
chair the Systems of Care Working Group. The STEP team will develop operational cores and
scientific advisory groups designed to support three broad categories of trials: expansion of EVT
indications, innovative EVT devices and concomitant medical therapies, and novel pre- and early-
hospital technologies and systems of care.
 PCKβ-Inhibitor to prevent tPA-mediated hemorrhagic transformation: Dr. Daniel Lawrence, Colin
Greineder, MD, PhD and Phillip Scott, MD, MBA are exploring a phase I/II trial based on work from
the Lawrence Lab.
 TEsting Multiple PrehOspital therapies for the Emergency Management of Stroke (TEMPO-EMS):
Dr. William Meurer, along with Drs. Sanossian, Saver, and Hess, as multiple PIs, developed this
innovative phase 2 adaptive multi-agent, multi-arm study. This trial was not funded. There is potential for
reconsideration as a platform trial.

14. RCC-17 Representation to
NIH StrokeNet (national)
• ASWG
(Acute Stroke Working Group)
• Dr. Cemal Sozener (On)
• Dr. Adrianne Haggins (DEI
Liaison)
• Dr. Phillip Scott (Off)
• Education Committee
• Dr. Devin Brown
• Dr. Cemal Sozener

15. StrokeNet Impact

16. Looking Ahead

17. Thank You!
• Sherry Goldfarb – StrokeNet
Project Manager
• ALL our site PI – current and past
• Our UM stroke team – current
and past
• The many mentors we have had
over the years!

18. An Invitation. Join Us…
for The Second Decade of StrokeNet
• Multiple persons in this room today have been impacted by stroke
• ALL NIH clinical stroke trials will be conducted through the network!
• We are here to help you develop and implement your trial faster,
better, stronger than in days past
• EM is THE front door for all acute care stroke trials
• EM is an opportunity for primary and secondary stroke prevention
trials
• StrokeNet is THE place to make a difference - by executing well-
designed trials, enhancing your training, and developing and leading
your own trial!

19. Thank You!
phslctt@med.umich.edu 734-232-2142