Strategy for Improving Stroke Treatment Response
Start Date
3/18/2024
Completion Date
12/1/2027
Summary
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.
Detailed Description
SISTER is a Phase II, Bayesian, adaptive, randomized, dose-finding trial of TS23 in patients with acute ischemic stroke. Patients with an anterior cerebral circulation acute ischemic stroke and present between 4.5 to 24 hours of their last known well with a presenting NIH Stroke Scale Score \>/=4 (with the patient having a clearly disabling deficit if the NIHSS is 4 or 5) and an imaging evidence of salvageable brain tissue will be eligible and will be approached for an informed consent for study participation. After informed consent is provided, the study will randomize to 4 doses of TS23 and placebo. The trial will enroll up to 300 subjects at up to 60 participating US sites and up to 17 Canadian sites. The effects of TS23 will be evaluated on two following primary outcomes using a utility function: 1) primary safety outcome: any intracerebral hemorrhage at 30 (+/-4) hours and 2) primary efficacy outcome: NIH Stroke Scale score at 30 (+/-4) hours after drug administration. The study will follow participants for 90 (+/-7) days. Primary Objective: To identify a dose of TS23 that is safe and more efficacious than placebo for the treatment of patients from 4.5 to 24 hours of last known well, who have evidence of core-penumbra mismatch on perfusion imaging and are not a candidate for standard of care reperfusion therapies.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
TS23
Conditions
Locations
University of Alabama Hospital
Birmingham, Alabama 35233
United States
Banner University Medical Center
Phoenix, Arizona 85006
United States
Mayo Clinic Phoenix
Phoenix, Arizona 85054
United States
Banner University Medical Center - Tucson
Tucson, Arizona 85719
United States
UCSD Health La Jolla
La Jolla, California 92093
United States
Kaiser Permanente Los Angeles
Los Angeles, California 90027
United States
Sutter Medical Center
Sacramento, California 95816
United States
UCSD Medical Center- Hillcrest Hospital
San Diego, California 92103
United States
Hartford Hospital
Hartford, Connecticut 06102
United States
Yale New Haven Hospital
New Haven, Connecticut 06511
United States
Christiana Hospital
Newark, Delaware 19718
United States
UF Health Shands Hospital
Gainesville, Florida 32608
United States
Jackson Memorial Hospital
Miami, Florida 33136
United States
Grady Memorial Hospital
Atlanta, Georgia 30303
United States
University of Chicago Medical Center
Chicago, Illinois 60637
United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa 52242
United States
Baptist Healthcare System, Inc.
Lexington, Kentucky 40503
United States
University of Louisville Hospital
Louisville, Kentucky 40202
United States
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
Massachusetts General Hospital
Boston, Massachusetts 02171
United States
M Health Fairview Ridges Hospital
Burnsville, Minnesota 55337
United States
M Health Fairview Southdale Hospital
Edina, Minnesota 55435
United States
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota 55455
United States
United Hospital
Saint Paul, Minnesota 55102
United States
Barnes Jewish Hospital
St Louis, Missouri 63110
United States
JFK Medical Center
Edison, New Jersey 08837
United States
NYU Langone Health
Brooklyn, New York 11220
United States
Buffalo General Medical Center
Buffalo, New York 14203
United States
North Shore University Hospital
Manhasset, New York 11030
United States
Mount Sinai West
New York, New York 10029
United States
The Mount Sinai Hospital
New York, New York 10029
United States
NYP Columbia University Medical Center
New York, New York 10032
United States
SUNY Upstate Medical University
Syracuse, New York 13202
United States
Westchester Medical Center
Valhalla, New York 10595
United States
Duke University Hospital
Durham, North Carolina 27710
United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina 27157
United States
University of Cincinnati Medical Center
Cincinnati, Ohio 45267
United States
OSU Wexner Medical Center
Columbus, Ohio 43210
United States
Ascension St. John
Tulsa, Oklahoma 74104
United States
Providence St. Vincent Medical Center
Portland, Oregon 97225
United States
Saint Luke's Hospital of Bethlehem Pennsylvania
Bethlehem, Pennsylvania 18015
United States
Temple University Hospital
Philadelphia, Pennsylvania 19140
United States
Rhode Island Hospital
Providence, Rhode Island 02903
United States
Medical University of South Carolina University Hospital
Charleston, South Carolina 32608
United States
Prisma Health Greenville Memorial
Greenville, South Carolina 29605
United States
Methodist University Hospital
Memphis, Tennessee 38104
United States
Memorial Hermann Texas Medical Center
Houston, Texas 77030
United States
University of Utah Healthcare
Salt Lake City, Utah 84132
United States
UVA Medical Center
Charlottesville, Virginia 22901
United States
VCU Medical Center
Richmond, Virginia 23298
United States
Harborview Medical Center
Seattle, Washington 98104
United States
Ascension Columbia St. Mary's Hospital
Milwaukee, Wisconsin 53211
United States