Strategy for Improving Stroke Treatment Response
SISTER
2 other identifiers
interventional
300
1 country
52
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2024
Typical duration for phase_2
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2023
CompletedFirst Posted
Study publicly available on registry
July 17, 2023
CompletedStudy Start
First participant enrolled
March 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
June 2, 2026
June 1, 2026
3.3 years
July 8, 2023
June 1, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
The proportion of patients with ANY intracerebral hemorrhage (ICH)
Any ICH visualized on the follow-up CT scan
At 30 (+/- 4) hours after study drug
Stroke severity as measured by the National Institutes of Health Stroke Scale (NIHSS)
NIHSS is a stroke severity score that ranges from 0 to 42, with higher numbers indicating a more severe stroke. The NIHSS will be adjusted for the baseline value in analysis.
At 30 (+/- 4) hours after study drug
Secondary Outcomes (13)
Improvement in level of global disability measured by modified Rankin Score (mRS distribution)
90 (±7) days
Frequency of Modified Rankin (mRS) score of 0-1 or returning to pre-stroke mRS.
Proportion of patients with modified Rankin scale score 0-1 or return to pre-stroke mRS at 90 (+/-7) days.
NIHSS
72 (±12) hours (or at discharge if sooner) after study drug administration.
α2-antiplasmin (a2AP) level in plasma
at 3 (±1) h after completion of study drug administration
Matrix metalloproteinase-9 level in plasma
3 (±1) h after completion of study drug
- +8 more secondary outcomes
Study Arms (5)
Placebo
PLACEBO COMPARATORPlacebo
Dose 1 TS23
EXPERIMENTALlow dose
Dose 2 TS23
EXPERIMENTALnext higher dose
Dose 3 TS23
EXPERIMENTALnext higher dose
Dose 4 TS23
EXPERIMENTALhighest dose
Interventions
Eligibility Criteria
You may qualify if:
- Age 18 years and older
- Suspected anterior circulation acute ischemic stroke
- NIH Stroke Scale score ≥4 prior to randomization
- a. The participant must have a clearly disabling deficit if NIHSS is 4-5.
- Favorable baseline neuroimaging consisting of all of the following:
- ASPECTS of 6 or more on CT (or ASPECTS of ≥7 on MRI)
- Favorable perfusion imaging on CT perfusion (CTP)/MR-perfusion weighted imaging (PWI) consisting of all of the following:
- i. Mismatch ratio of penumbra: core \>1.2 ii. Mismatch volume \>10 cc iii. Core \<70 cc
- c. If CT hypodensity is present, then in the investigator's visual assessment, the total acute infarct volume combined area of (a) the CT hypodensity and (b) the perfusion-based core volume (CBF\<30%) should be smaller than perfusion-based volume (area of Tmax\>6s minus CBF\<30%).
- Able to receive assigned study drug within 4.5 to 24 hours of stroke onset or last known well.
- Able to receive assigned study drug within 120 minutes of qualifying perfusion imaging. \*
- Informed consent for the study participation obtained from participant or their legally authorized representatives.
You may not qualify if:
- Received endovascular treatment with clot engagement.
- Patients who undergo groin puncture but clot engagement is not attempted due to spontaneous distal migration are permitted to be enrolled in the trial if all other eligibility criteria are met.
- Patients who undergo groin puncture but clot is not engaged due to reasons other than spontaneous distal migration are NOT permitted.
- Received or planned to receive intravenous thrombolysis.
- Pre-stroke modified Rankin score \>2.
- Previous treatment with TS23 or known previous allergy to antibody therapy.
- Known pregnancy, women who are breastfeeding or plan to breastfeed within 3 months of receiving TS23 or have a positive urine or serum pregnancy test for women of childbearing potential.
- Known previous stroke in the past 90 days.
- Known previous intracranial hemorrhage, intracranial neoplasm, subarachnoid hemorrhage, or arterial venous malformation.
- Known active diagnosis of intracranial neoplasm.
- Clinical presentation suggestive of a subarachnoid hemorrhage, even if initial CT scan was normal.
- Surgery or biopsy of parenchymal organ in the past 30 days.
- Known trauma with internal injuries or persistent ulcerative wounds in the past 30 days.
- Severe head trauma in the past 90 days.
- Persistent systolic blood pressure \>180mmHg or diastolic blood pressure \>105mmHg despite best medical management.
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Translational Sciences, Inc.lead
- University of Cincinnaticollaborator
- University of Arizonacollaborator
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
- Medical University of South Carolinacollaborator
Study Sites (52)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eva Mistry, MBBS
University of Cincinnati
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2023
First Posted
July 17, 2023
Study Start
March 18, 2024
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
June 2, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
The SISTER trial will comply with the NIH Public Access Policy, which ensures that the public has access to the published results of NIH funded research, and the StrokeNet SOP (ADM 03) regarding results publication. Manuscripts and abstracts that use data from SISTER require approval from the Publication Committee of an original proposal before the concept may proceed. All publications will include this acknowledgement: "Research reported in this publication was supported by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health under Award Number \[to be determined\]. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health."