Actively Recruiting
Strategy for Improving Stroke Treatment Response
Led by Translational Sciences, Inc. · Updated on 2026-03-30
300
Participants Needed
52
Research Sites
193 weeks
Total Duration
On this page
Sponsors
T
Translational Sciences, Inc.
Lead Sponsor
U
University of Cincinnati
Collaborating Sponsor
AI-Summary
What this Trial Is About
SISTER is a Phase-II, prospective, randomized, placebo-controlled, blinded, dose finding trial that aims to determine the safety and preliminary efficacy of TS23, a monoclonal antibody against the alpha-2 antiplasmin (a2-AP), in acute ischemic stroke.
CONDITIONS
Official Title
Strategy for Improving Stroke Treatment Response
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and older
- Suspected anterior circulation acute ischemic stroke
- NIH Stroke Scale score 4 or higher prior to randomization
- Clearly disabling deficit if NIH Stroke Scale score is 4 or 5
- Favorable baseline neuroimaging with ASPECTS 6 or more on CT or 7 or more on MRI
- Favorable perfusion imaging showing penumbra to core mismatch ratio over 1.2, mismatch volume over 10 cc, and core less than 70 cc
- If CT hypodensity is present, total acute infarct volume must be smaller than perfusion-based volume
- Able to receive study drug within 4.5 to 24 hours of stroke onset or last known well
- Able to receive study drug within 120 minutes of qualifying perfusion imaging
- Informed consent obtained from participant or legally authorized representative
You will not qualify if you...
- Received endovascular treatment with clot engagement (except if groin puncture was done but clot engagement not attempted due to spontaneous distal migration)
- Received or planned to receive intravenous thrombolysis
- Pre-stroke modified Rankin score greater than 2
- Previous treatment with TS23 or known allergy to antibody therapy
- Known pregnancy, breastfeeding, planning to breastfeed within 3 months of study drug, or positive pregnancy test
- Previous stroke within past 90 days
- Previous intracranial hemorrhage, intracranial neoplasm, subarachnoid hemorrhage, or arteriovenous malformation
- Active diagnosis of intracranial neoplasm
- Clinical signs suggesting subarachnoid hemorrhage even if initial CT was normal
- Surgery or biopsy of parenchymal organ within past 30 days
- Trauma with internal injuries or persistent ulcerative wounds within past 30 days
- Severe head trauma within past 90 days
- Persistent high blood pressure despite best medical management
- Serious systemic hemorrhage within past 30 days
- Known bleeding disorders, coagulation factor deficiency, or oral anticoagulant therapy with INR over 1.7
- Platelet count less than 100,000/mm3
- Hematocrit less than 25%
- Elevated aPTT above normal laboratory range
- Creatinine over 4 mg/dl or receiving renal dialysis
- Received unfractionated heparin within 24 hours without normal aPTT
- Received full dose low molecular weight heparins within 24 hours
- Received Factor Xa inhibitors within past 48 hours
- Received direct thrombin inhibitors within past 48 hours
- Received glycoprotein IIb/IIIa inhibitors within past 14 days
- Known neurological or psychiatric disease affecting evaluations
- Current participation in another research drug treatment protocol
- Acute myocardial infarction, pulmonary embolism, deep venous thrombosis, or other thrombotic event requiring anticoagulation or antiplatelet treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 52 locations
1
University of Alabama Hospital
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Banner University Medical Center
Phoenix, Arizona, United States, 85006
Actively Recruiting
3
Mayo Clinic Phoenix
Phoenix, Arizona, United States, 85054
Withdrawn
4
Banner University Medical Center - Tucson
Tucson, Arizona, United States, 85719
Not Yet Recruiting
5
UCSD Health La Jolla
La Jolla, California, United States, 92093
Actively Recruiting
6
Kaiser Permanente Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
7
Sutter Medical Center
Sacramento, California, United States, 95816
Withdrawn
8
UCSD Medical Center- Hillcrest Hospital
San Diego, California, United States, 92103
Actively Recruiting
9
Hartford Hospital
Hartford, Connecticut, United States, 06102
Actively Recruiting
10
Yale New Haven Hospital
New Haven, Connecticut, United States, 06511
Actively Recruiting
11
Christiana Hospital
Newark, Delaware, United States, 19718
Actively Recruiting
12
UF Health Shands Hospital
Gainesville, Florida, United States, 32608
Terminated
13
Jackson Memorial Hospital
Miami, Florida, United States, 33136
Actively Recruiting
14
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Actively Recruiting
15
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
16
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
Withdrawn
17
Baptist Healthcare System, Inc.
Lexington, Kentucky, United States, 40503
Actively Recruiting
18
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
19
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
20
Massachusetts General Hospital
Boston, Massachusetts, United States, 02171
Actively Recruiting
21
M Health Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Actively Recruiting
22
M Health Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Actively Recruiting
23
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
24
United Hospital
Saint Paul, Minnesota, United States, 55102
Withdrawn
25
Barnes Jewish Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
26
JFK Medical Center
Edison, New Jersey, United States, 08837
Actively Recruiting
27
NYU Langone Health
Brooklyn, New York, United States, 11220
Actively Recruiting
28
Buffalo General Medical Center
Buffalo, New York, United States, 14203
Withdrawn
29
North Shore University Hospital
Manhasset, New York, United States, 11030
Actively Recruiting
30
Mount Sinai West
New York, New York, United States, 10029
Actively Recruiting
31
The Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
32
NYP Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
33
SUNY Upstate Medical University
Syracuse, New York, United States, 13202
Actively Recruiting
34
Westchester Medical Center
Valhalla, New York, United States, 10595
Not Yet Recruiting
35
Duke University Hospital
Durham, North Carolina, United States, 27710
Actively Recruiting
36
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Terminated
37
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
Actively Recruiting
38
OSU Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
39
Ascension St. John
Tulsa, Oklahoma, United States, 74104
Actively Recruiting
40
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Actively Recruiting
41
Saint Luke's Hospital of Bethlehem Pennsylvania
Bethlehem, Pennsylvania, United States, 18015
Actively Recruiting
42
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
43
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
44
Medical University of South Carolina University Hospital
Charleston, South Carolina, United States, 32608
Actively Recruiting
45
Prisma Health Greenville Memorial
Greenville, South Carolina, United States, 29605
Actively Recruiting
46
Methodist University Hospital
Memphis, Tennessee, United States, 38104
Actively Recruiting
47
Memorial Hermann Texas Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
48
University of Utah Healthcare
Salt Lake City, Utah, United States, 84132
Withdrawn
49
UVA Medical Center
Charlottesville, Virginia, United States, 22901
Actively Recruiting
50
VCU Medical Center
Richmond, Virginia, United States, 23298
Not Yet Recruiting
51
Harborview Medical Center
Seattle, Washington, United States, 98104
Actively Recruiting
52
Ascension Columbia St. Mary's Hospital
Milwaukee, Wisconsin, United States, 53211
Actively Recruiting
Research Team
R
Rebeca Aragon Garcia, BS, CCRC
CONTACT
P
Pam Plummer, MSN,RN, CCRC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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