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Search / Trial NCT05948566

Strategy for Improving Stroke Treatment Response

Launched by TRANSLATIONAL SCIENCES, INC. · Jul 8, 2023

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

ClinConnect Summary

The SISTER trial is a research study looking at a new treatment for acute ischemic stroke, which happens when a blood clot blocks blood flow to the brain. This study is testing a medication called TS23, designed to help improve how the body responds to stroke treatment. It’s a Phase 2 trial, meaning it's in the early stages of testing to see if the medication is safe and effective. The study is currently recruiting participants who are at least 18 years old and are experiencing certain types of strokes, indicated by specific scores on stroke assessments and brain scans.

To be eligible for the trial, participants need to have a confirmed stroke and must be able to receive the study medication within a specific time frame after the stroke begins. Participants will be closely monitored throughout the study, and their health will be assessed to see how well the treatment works. It’s important to note that individuals with certain medical conditions or those who have recently received specific treatments may not qualify for this trial. If you or someone you know is interested, please talk to a healthcare provider for more details.

Gender

ALL

Eligibility criteria

  • 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:
  • a. ASPECTS of 6 or more on CT (or ASPECTS of ≥7 on MRI) b. 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
  • 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.

About Translational Sciences, Inc.

Translational Sciences, Inc. is a leading clinical trial sponsor dedicated to advancing innovative therapeutic solutions through rigorous research and development. With a focus on bridging the gap between laboratory discoveries and clinical application, the company specializes in conducting Phase I to Phase III clinical trials across a range of therapeutic areas. Translational Sciences, Inc. is committed to ensuring the highest standards of safety, efficacy, and regulatory compliance, leveraging cutting-edge methodologies and a collaborative approach to accelerate the development of new treatments. Their expert team fosters strong partnerships with stakeholders, including academic institutions and biopharmaceutical companies, to enhance the translational process and improve patient outcomes.

Locations

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Providence, Rhode Island, United States

Manhasset, New York, United States

Saint Paul, Minnesota, United States

Louisville, Kentucky, United States

Seattle, Washington, United States

Miami, Florida, United States

Portland, Oregon, United States

Philadelphia, Pennsylvania, United States

Houston, Texas, United States

Hartford, Connecticut, United States

Chicago, Illinois, United States

Newark, Delaware, United States

Winston Salem, North Carolina, United States

Cincinnati, Ohio, United States

Cincinnati, Ohio, United States

Atlanta, Georgia, United States

Los Angeles, California, United States

Memphis, Tennessee, United States

Syracuse, New York, United States

Durham, North Carolina, United States

Phoenix, Arizona, United States

Buffalo, New York, United States

Houston, Texas, United States

Iowa City, Iowa, United States

Saint Louis, Missouri, United States

Sacramento, California, United States

New York, New York, United States

Gainesville, Florida, United States

Columbus, Ohio, United States

Boston, Massachusetts, United States

Birmingham, Alabama, United States

Salt Lake City, Utah, United States

New York, New York, United States

New Haven, Connecticut, United States

Phoenix, Arizona, United States

Brooklyn, New York, United States

Milwaukee, Wisconsin, United States

New York, New York, United States

Tulsa, Oklahoma, United States

Edina, Minnesota, United States

Minneapolis, Minnesota, United States

Burnsville, Minnesota, United States

La Jolla, California, United States

San Diego, California, United States

Greenville, South Carolina, United States

Edison, New Jersey, United States

Charleston, South Carolina, United States

Charlottesville, Virginia, United States

Arcadia, California, United States

Lexington, Kentucky, United States

Bethlehem, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

Eva Mistry, MBBS

Principal Investigator

University of Cincinnati

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported