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Clinical Trials in the USA / NCT05948566
Recruiting Phase 2

Strategy for Improving Stroke Treatment Response

NCT05948566 · tracked via the Priya Life Science USA tracker
Sponsor
Translational Sciences, Inc.
Phase
Phase 2
Started
2024-03-18
Last updated
2026-08-24

Condition(s) studied

Ischemic Stroke

Investigational drug(s) / intervention(s)

TS23

TS23: Monoclonal antibody

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Age 18 years and older 2. Suspected anterior circulation acute ischemic stroke 3. NIH Stroke Scale score ≥4 prior to randomization a. The participant must have a clearly disabling deficit if NIHSS is 4-5. 4. Favorable baseline neuroimaging consisting of all of the following: 1. ASPECTS of 6 or more on CT (or ASPECTS of ≥7 on MRI) 2. 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%). 5. Able to receive assigned study drug within 4.5 to 24 hours of stroke onset or last known well. 6. Able to receive assigned study drug within 120 minutes of qualifying perfusion imaging. \* 7. Informed consent for the study participation obtained from participant or their legally authorized representatives. * Study drug administration is encouraged within 90 minutes after qualifying perfusion image but is allowed up to 120 minutes. After 120 minutes, another perfusion image to ensure that inclusion criteria are met is required. Exclusion Criteria: 1. Received endovascular treatment with clot engagement. 1. 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. 2. Patients who undergo groin puncture but clot is not engaged due to reasons other than spontaneous distal migration are NOT permitted. 2. Received or planned to receive intravenous thrombolysis. 3. Pre-stroke modified Rankin score \>2. 4. Previous treatment with TS23 or known previous allergy to antibody therapy. 5. 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. 6. Known previous stroke in the past 90 days. 7. Known previous intracranial hemorrhage, intracranial neoplasm, subarachnoid hemorrhage, or arterial venous malformation. 8. Known active diagnosis of intracranial neoplasm. 9. Clinical presentation suggestive of a subarachnoid hemorrhage, even if initial CT scan was normal. 10. Surgery or biopsy of parenchymal organ in the past 30 days. 11. Known trauma with internal injuries or persistent ulcerative wounds in the past 30 days. 12. Severe head trauma in the past 90 days. 13. Persistent systolic blood pressure \>180mmHg or diastolic blood pressure \>105mmHg despite best medical management. 14. Serious systemic hemorrhage in the past 30 days. 15. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with International Normalized Ratio (INR) \>1.7. 16. Platelets \<100,000/mm3. 17. Hematocrit \<25 %. 18. Elevated aPTT above laboratory upper limit of normal. 19. Creatinine \> 4 mg/dl, or patients receiving renal dialysis, regardless of creatinine. 20. Received the following within the previous 24 hours: 1. If patient received unfractionated heparin within the last 24 hours, the patient must have an aPTT within normal range prior to enrollment. 2. Low molecular weight heparins such as Dalteparin, enoxaparin, tinzaparin in full dose within the previous 24 hours. 21. Received Factor Xa inhibitors (such as Fondaparinux, apixaban or rivaroxaban) within the past 48 hours. 22. Received direct thrombin inhibitors (e.g., argatroban, dabigatran, bivalirudin, desirudin, lepirudin) within 48 hours. 23. Received glycoprotein IIb/IIIa inhibitors within the past 14 days. 24. Known pre-existing neurological or psychiatric disease which would confound the neurological/functional evaluations. 25. Current participation in another research drug treatment protocol (i.e., participants could not start another experimental agent until after 90 days). 26. Concurrent acute myocardial infarction, pulmonary embolism, deep venous thrombosis or other thrombotic event that requires anticoagulation or anti-platelet treatment.

Primary outcome measure(s)

Trial sites (52)

FacilityCityRegionStatus
University of Alabama Hospital Birmingham Alabama Recruiting
Banner University Medical Center Phoenix Arizona Recruiting
Mayo Clinic Phoenix Phoenix Arizona Withdrawn
Banner University Medical Center - Tucson Tucson Arizona Recruiting
UCSD Health La Jolla La Jolla California Recruiting
Kaiser Permanente Los Angeles Los Angeles California Recruiting
Sutter Medical Center Sacramento California Withdrawn
UCSD Medical Center- Hillcrest Hospital San Diego California Recruiting
Hartford Hospital Hartford Connecticut Recruiting
Yale New Haven Hospital New Haven Connecticut Recruiting
Christiana Hospital Newark Delaware Active Not Recruiting
UF Health Shands Hospital Gainesville Florida Terminated
Jackson Memorial Hospital Miami Florida Recruiting
Grady Memorial Hospital Atlanta Georgia Recruiting
University of Chicago Medical Center Chicago Illinois Recruiting
University of Iowa Hospitals & Clinics Iowa City Iowa Withdrawn
Baptist Healthcare System, Inc. Lexington Kentucky Recruiting
University of Louisville Hospital Louisville Kentucky Recruiting
Brigham and Women's Hospital Boston Massachusetts Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
M Health Fairview Ridges Hospital Burnsville Minnesota Recruiting
M Health Fairview Southdale Hospital Edina Minnesota Recruiting
M Health Fairview University of Minnesota Medical Center Minneapolis Minnesota Recruiting
United Hospital Saint Paul Minnesota Withdrawn
Barnes Jewish Hospital St Louis Missouri Recruiting
JFK Medical Center Edison New Jersey Recruiting
NYU Langone Health Brooklyn New York Recruiting
Buffalo General Medical Center Buffalo New York Withdrawn
North Shore University Hospital Manhasset New York Recruiting
Mount Sinai West New York New York Recruiting
The Mount Sinai Hospital New York New York Recruiting
NYP Columbia University Medical Center New York New York Recruiting
SUNY Upstate Medical University Syracuse New York Recruiting
Westchester Medical Center Valhalla New York Withdrawn
Duke University Hospital Durham North Carolina Recruiting
Wake Forest Baptist Medical Center Winston-Salem North Carolina Terminated
University of Cincinnati Medical Center Cincinnati Ohio Recruiting
OSU Wexner Medical Center Columbus Ohio Recruiting
Ascension St. John Tulsa Oklahoma Recruiting
Providence St. Vincent Medical Center Portland Oregon Recruiting

+ 12 more sites — see the full list on the official registry below.

More Translational Sciences, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05948566 on ClinicalTrials.gov ↗ ← All trials in the USA