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RecruitingPhase 2

Strategy for Improving Stroke Treatment Response

Translational Sciences, Inc. · with University of Cincinnati, National Institute of Neurological Disorders and Stroke (NINDS) · NCT05948566

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
300
US sites recruiting
38
Study start
March 18, 2024
Record last updated
October 19, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: TS23

Conditions: Ischemic Stroke

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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.
  • Anticipate being 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.

Exclusion Criteria

  • 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.
  • Serious systemic hemorrhage in the past 30 days.
  • Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with International Normalized Ratio (INR) >1.7.
  • Platelets \<100,000/mm3.
  • Hematocrit \<25 %.
  • Elevated aPTT above laboratory upper limit of normal.
  • Creatinine > 4 mg/dl, or patients receiving renal dialysis, regardless of creatinine.
  • Received the following within the previous 24 hours:
  • If patient received unfractionated heparin within the last 24 hours, the patient must have an aPTT within normal range prior to enrollment.
  • Low molecular weight heparins such as Dalteparin, enoxaparin, tinzaparin in full dose within the previous 24 hours.
  • Received Factor Xa inhibitors (such as Fondaparinux, apixaban or rivaroxaban) within the past 48 hours.
  • Received direct thrombin inhibitors (e.g., argatroban, dabigatran, bivalirudin, desirudin, lepirudin) within 48 hours.
  • Received glycoprotein IIb/IIIa inhibitors within the past 14 days.
  • Known pre-existing neurological or psychiatric disease which would confound the neurological/functional evaluations.
  • Current participation in another research drug treatment protocol (i.e., participants could not start another experimental agent until after 90 days).
  • Concurrent acute myocardial infarction, pulmonary embolism, deep venous thrombosis or other thrombotic event that requires anticoagulation or anti-platelet treatment.

Recruiting US locations

  • University of Alabama Hospital

    Birmingham, AL 35233

    Site contact: Felix Guerra Castanon, MD · fguerracastanon@uabmc.edu

  • Banner University Medical Center

    Phoenix, AZ 85006

    Site contact: Savdeep Singh, MD · savdeepsingh@arizona.edu

  • Banner University Medical Center - Tucson

    Tucson, AZ 85719

    Site contact: Firas Kaddouh, MD, MHS · firaskaddouh@arizona.edu

  • UCSD Health La Jolla

    La Jolla, CA 92093

    Site contact: Maryo Jajo · mjajo@health.ucsd.edu

  • Kaiser Permanente Los Angeles

    Los Angeles, CA 90027

    Site contact: Navdeep Sangha, MD · navdeep.x.sangha@kp.org

  • UCSD Medical Center- Hillcrest Hospital

    San Diego, CA 92103

    Site contact: Maryo Jajo · mjajo@health.ucsd.edu

  • Hartford Hospital

    Hartford, CT 06102

    Site contact: Ajay Tunguturi, MD · ajay.tunguturi@hhchealth.org

  • Yale New Haven Hospital

    New Haven, CT 06511

    Site contact: James Giles, MD, PhD · james.giles@yale.edu

  • Jackson Memorial Hospital

    Miami, FL 33136

    Site contact: Andrea Escobar · a.escobar1@med.miami.edu

  • Grady Memorial Hospital

    Atlanta, GA 30303

    Site contact: Nicolas Bianchi, MD · nicolas.a.bianchi@emory.edu

  • Baptist Healthcare System, Inc.

    Lexington, KY 40503

    Site contact: Murali Kolikonda, MD · murali.kolikonda@bhsi.com

  • University of Louisville Hospital

    Louisville, KY 40202

    Site contact: Isaac Abecassis, MD · Isaac.Abecassis@uoflhealth.org

  • Brigham and Women's Hospital

    Boston, MA 02115

    Site contact: Rahul Mahajan, MD, PhD · rmahajan@bwh.harvard.edu

  • Massachusetts General Hospital

    Boston, MA 02171

    Site contact: Aneesh Singhal, MD, MBBS · ASINGHAL@mgh.harvard.edu

  • M Health Fairview Ridges Hospital

    Burnsville, MN 55337

    Site contact: Jessica Staloch · staloch@umn.edu

  • M Health Fairview Southdale Hospital

    Edina, MN 55435

    Site contact: Jessica Staloch · staloch@umn.edu

  • M Health Fairview University of Minnesota Medical Center

    Minneapolis, MN 55455

    Site contact: Jessica Staloch · staloch@umn.edu

  • Barnes Jewish Hospital

    St Louis, MO 63110

    Site contact: Charles Kircher, MD · charles.kircher@wustl.edu

  • JFK Medical Center

    Edison, NJ 08837

    Site contact: Nancy Gadallah, DO · nancy.gadallah@hmhn.org

  • NYU Langone Health

    Brooklyn, NY 11220

    Site contact: Maria Cotrina-Vidal · maria.cotrina@nyulangone.org

  • North Shore University Hospital

    Manhasset, NY 11030

    Site contact: Rohan Arora · neuroscienceresearch@northwell.edu

  • The Mount Sinai Hospital

    New York, NY 10029

    Site contact: Laura Stein, MD, MPH · laura.stein@mountsinai.org

  • NYP Columbia University Medical Center

    New York, NY 10032

    Site contact: Angela Velazquez · Agv2113@cumc.columbia.edu

  • SUNY Upstate Medical University

    Syracuse, NY 13202

    Site contact: Deb Lena · debl@upstate.edu

  • Duke University Hospital

    Durham, NC 27710

    Site contact: Rosanna Escobar-Spadina · rosanna.escobar@duke.edu

  • University of Cincinnati Medical Center

    Cincinnati, OH 45267

    Site contact: Yasmin Aziz, MD · azizyn@ucmail.uc.edu

  • OSU Wexner Medical Center

    Columbus, OH 43210

    Site contact: Jan Bittar, MD · jan.bittar@osumc.edu

  • Ascension St. John

    Tulsa, OK 74104

    Site contact: Rahul Rahangdale, MD · rahul.rahangdale@ascension.org

  • Providence St. Vincent Medical Center

    Portland, OR 97225

    Site contact: Kishan Patel, MD · kishan.patel@providence.org

  • Saint Luke's Hospital of Bethlehem Pennsylvania

    Bethlehem, PA 18015

    Site contact: Daniel Ackerman, MD · Daniel.Ackerman@sluhn.org

  • Temple University Hospital

    Philadelphia, PA 19140

    Site contact: Nina Gentile, MD · ngentile@temple.edu

  • Rhode Island Hospital

    Providence, RI 02903

    Site contact: Farhan Khan, MD · fkhan@brownhealth.org

  • Medical University of South Carolina University Hospital

    Charleston, SC 32608

    Site contact: Caitlan LeMatty · lemattyc@musc.edu

  • Prisma Health Greenville Memorial

    Greenville, SC 29605

    Site contact: Sanjeev Sivakumar, MD · Sanjeev.Sivakumar@prismahealth.org

  • Methodist University Hospital

    Memphis, TN 38104

    Site contact: Quentin Thacker · qthacker@uthsc.edu

  • Memorial Hermann Texas Medical Center

    Houston, TX 77030

    Site contact: Prasen Marella · prasen.r.marella@uth.tmc.edu

  • UVA Medical Center

    Charlottesville, VA 22901

    Site contact: Amna Sohail, MBBS, MD · ZRX5FU@uvahealth.org

  • Ascension Columbia St. Mary's Hospital

    Milwaukee, WI 53211

    Site contact: Lakiesha Coleman · lakiesha.coleman@ascension.org

Study contacts (from the official record)

  • Rebeca Aragon Garcia, BS, CCRC · 9736688644 · aragonra@ucmail.uc.edu
  • Pam Plummer, MSN,RN, CCRC · 5138852437 · plummepa@ucmail.uc.edu
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Strategy for Improving Stroke Treatment Response (NCT05948566) | Bored Studies