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STRATEGI FÖR ATT FÖRBÄTTRA STROKEBEHANDLINGENS SVAR (SISTER)

13 oktober 2026 uppdaterad av: Translational Sciences, Inc.

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.

Studieöversikt

Status

Rekrytering

Betingelser

Ischemisk stroke

Intervention / Behandling

Biologisk: TS23

Detaljerad beskrivning

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. Patients with an NIHSS of 4-5 must have a new, disabling neuro-logic deficit to be eligible for the study. After informed consent is provided, the study will randomize to 4 doses of TS23 and placebo. The trial will enroll up to 150 subjects at up to 70 participating US 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.

Studietyp

Interventionell

Inskrivning (Beräknad)

300

Fas

Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Namn: Pam Plummer, MSN,RN, CCRC
Telefonnummer: 5138852437
E-post: plummepa@ucmail.uc.edu

Studera Kontakt Backup

Namn: Rebeca Aragon Garcia, BS, CCRC
Telefonnummer: 9736688644
E-post: aragonra@ucmail.uc.edu

Studieorter

Förenta staterna
- Alabama
  - Birmingham, Alabama, Förenta staterna, 35233
    - Rekrytering
    - University of Alabama Hospital
    - Kontakt:
      
      Felix Guerra Castanon, MD
      
      E-post: fguerracastanon@uabmc.edu
    - Huvudutredare:
      
      Felix Guerra Castanon, MD
- Arizona
  - Phoenix, Arizona, Förenta staterna, 85006
    - Rekrytering
    - Banner University Medical Center
    - Huvudutredare:
      
      Savdeep Singh, MD
    - Kontakt:
      
      Savdeep Singh, MD
      
      E-post: savdeepsingh@arizona.edu
  - Phoenix, Arizona, Förenta staterna, 85054
    - Indragen
    - Mayo Clinic Phoenix
  - Tucson, Arizona, Förenta staterna, 85719
    - Rekrytering
    - Banner University Medical Center - Tucson
    - Kontakt:
      
      Firas Kaddouh, MD, MHS
      
      E-post: firaskaddouh@arizona.edu
    - Huvudutredare:
      
      Firas Kaddouh, MD, MHS
- California
  - La Jolla, California, Förenta staterna, 92093
    - Rekrytering
    - UCSD Health La Jolla
    - Kontakt:
      
      Maryo Jajo
      
      E-post: mjajo@health.ucsd.edu
    - Huvudutredare:
      
      Royya Modir, MD
    - Kontakt:
      
      Royya Modir, MD
      
      E-post: rmodir@ucsd.edu
  - Los Angeles, California, Förenta staterna, 90027
    - Rekrytering
    - Kaiser Permanente Los Angeles
    - Kontakt:
      
      Navdeep Sangha, MD
      
      E-post: navdeep.x.sangha@kp.org
    - Huvudutredare:
      
      Navdeep Sangha, MD
  - Sacramento, California, Förenta staterna, 95816
    - Indragen
    - Sutter Medical Center
  - San Diego, California, Förenta staterna, 92103
    - Rekrytering
    - UCSD Medical Center- Hillcrest Hospital
    - Kontakt:
      
      Maryo Jajo
      
      E-post: mjajo@health.ucsd.edu
    - Huvudutredare:
      
      Royya Modir, MD
    - Kontakt:
      
      Royya' Modir, MD
      
      E-post: rmodir@ucsd.edu
- Connecticut
  - Hartford, Connecticut, Förenta staterna, 06102
    - Rekrytering
    - Hartford Hospital
    - Huvudutredare:
      
      Ajay Tunguturi, MD
    - Kontakt:
      
      Ajay Tunguturi, MD
      
      E-post: ajay.tunguturi@hhchealth.org
  - New Haven, Connecticut, Förenta staterna, 06511
    - Rekrytering
    - Yale New Haven Hospital
    - Kontakt:
      
      James Giles, MD, PhD
      
      E-post: james.giles@yale.edu
    - Huvudutredare:
      
      James Giles, MD, PhD
- Delaware
  - Newark, Delaware, Förenta staterna, 19718
    - Indragen
    - Christiana Hospital
- Florida
  - Gainesville, Florida, Förenta staterna, 32608
    - Avslutad
    - UF Health Shands Hospital
  - Miami, Florida, Förenta staterna, 33136
    - Rekrytering
    - Jackson Memorial Hospital
    - Kontakt:
      
      Andrea Escobar
      
      E-post: a.escobar1@med.miami.edu
    - Kontakt:
      
      Gillian Gordon Perue, MD, MBBS, DM
      
      E-post: ggordonperue@miami.edu
    - Huvudutredare:
      
      Gillian Gordon Perue, MD, MBBS, DM
- Georgia
  - Atlanta, Georgia, Förenta staterna, 30303
    - Rekrytering
    - Grady Memorial Hospital
    - Kontakt:
      
      Nicolas Bianchi, MD
      
      E-post: nicolas.a.bianchi@emory.edu
    - Huvudutredare:
      
      Nicolas Bianchi, MD
- Illinois
  - Chicago, Illinois, Förenta staterna, 60637
    - Aktiv, inte rekryterande
    - University of Chicago Medical Center
- Iowa
  - Iowa City, Iowa, Förenta staterna, 52242
    - Indragen
    - University of Iowa Hospitals & Clinics
- Kentucky
  - Lexington, Kentucky, Förenta staterna, 40503
    - Rekrytering
    - Baptist Healthcare System, Inc.
    - Kontakt:
      
      Franklin Echevarria
      
      E-post: Franklin.echevarriagonzalez@bhsi.com
    - Huvudutredare:
      
      Murali Kolikonda, MD
    - Kontakt:
      
      Murali Kolikonda, MD
      
      E-post: murali.kolikonda@bhsi.com
  - Louisville, Kentucky, Förenta staterna, 40202
    - Rekrytering
    - University of Louisville Hospital
    - Huvudutredare:
      
      Isaac Abecassis, MD
    - Kontakt:
      
      Isaac Abecassis, MD
      
      E-post: Isaac.Abecassis@uoflhealth.org
- Massachusetts
  - Boston, Massachusetts, Förenta staterna, 02115
    - Rekrytering
    - Brigham and Women's Hospital
    - Huvudutredare:
      
      Rahul Mahajan, MD, PhD
    - Kontakt:
      
      Rahul Mahajan, MD, PhD
      
      E-post: rmahajan@bwh.harvard.edu
  - Boston, Massachusetts, Förenta staterna, 02171
    - Rekrytering
    - Massachusetts General Hospital
    - Huvudutredare:
      
      Aneesh Singhal, MD, MBBS
    - Kontakt:
      
      Aneesh Singhal, MD, MBBS
      
      E-post: ASINGHAL@mgh.harvard.edu
- Minnesota
  - Burnsville, Minnesota, Förenta staterna, 55337
    - Rekrytering
    - M Health Fairview Ridges Hospital
    - Kontakt:
      
      Jessica Staloch
      
      E-post: staloch@umn.edu
    - Kontakt:
      
      Muhammad Affan, MD, MBBS
      
      E-post: affan004@umn.edu
    - Huvudutredare:
      
      Muhammad Affan, MD, MBBS
  - Edina, Minnesota, Förenta staterna, 55435
    - Rekrytering
    - M Health Fairview Southdale Hospital
    - Kontakt:
      
      Jessica Staloch
      
      E-post: staloch@umn.edu
    - Huvudutredare:
      
      Muhammad Affan, MD, MBBS
    - Kontakt:
      
      Muhammad Affan, MD,MBBS
      
      E-post: affan004@umn.edu
  - Minneapolis, Minnesota, Förenta staterna, 55455
    - Rekrytering
    - M Health Fairview University of Minnesota Medical Center
    - Kontakt:
      
      Jessica Staloch
      
      E-post: staloch@umn.edu
    - Kontakt:
      
      Muhammad Affan, MD,MBBS
      
      E-post: affan004@umn.edu
    - Huvudutredare:
      
      Muhammad Affan, MD,MBBS
  - Saint Paul, Minnesota, Förenta staterna, 55102
    - Indragen
    - United Hospital
- Missouri
  - St Louis, Missouri, Förenta staterna, 63110
    - Rekrytering
    - Barnes Jewish Hospital
    - Huvudutredare:
      
      Charles Kircher, MD
    - Kontakt:
      
      Charles Kircher, MD
      
      E-post: charles.kircher@wustl.edu
- New Jersey
  - Edison, New Jersey, Förenta staterna, 08837
    - Rekrytering
    - JFK Medical Center
    - Huvudutredare:
      
      Nancy Gadallah, DO
    - Kontakt:
      
      Nancy Gadallah, DO
      
      E-post: nancy.gadallah@hmhn.org
- New York
  - Brooklyn, New York, Förenta staterna, 11220
    - Rekrytering
    - NYU Langone Health
    - Kontakt:
      
      Maria Cotrina-Vidal
      
      E-post: maria.cotrina@nyulangone.org
    - Huvudutredare:
      
      Aaron Lord, MD, MSc
    - Kontakt:
      
      Aaron Lord, MD, MSc
      
      E-post: aaron.lord@nyulangone.org
  - Buffalo, New York, Förenta staterna, 14203
    - Indragen
    - Buffalo General Medical Center
  - Manhasset, New York, Förenta staterna, 11030
    - Rekrytering
    - North Shore University Hospital
    - Huvudutredare:
      
      Rohan Arora, MD
    - Kontakt:
      
      Rohan Arora
      
      E-post: neuroscienceresearch@northwell.edu
  - New York, New York, Förenta staterna, 10029
    - Rekrytering
    - The Mount Sinai Hospital
    - Kontakt:
      
      Laura Stein, MD, MPH
      
      E-post: laura.stein@mountsinai.org
    - Huvudutredare:
      
      Laura Stein, MD, MPH
  - New York, New York, Förenta staterna, 10032
    - Rekrytering
    - NYP Columbia University Medical Center
    - Huvudutredare:
      
      Shivani Ghoshal, MD
    - Kontakt:
      
      Angela Velazquez
      
      E-post: Agv2113@cumc.columbia.edu
    - Kontakt:
      
      Shivani Ghoshal, MD
      
      E-post: sg3450@cumc.columbia.edu;
  - New York, New York, Förenta staterna, 10029
    - Indragen
    - Mount Sinai West
  - Syracuse, New York, Förenta staterna, 13202
    - Rekrytering
    - SUNY Upstate Medical University
    - Kontakt:
      
      Deb Lena
      
      E-post: debl@upstate.edu
    - Huvudutredare:
      
      Julius-Gene LaTorre, MD, MPH
    - Kontakt:
      
      Julius-Gene LaTorre, MD, MPH
      
      E-post: latorrej@upstate.edu
  - Valhalla, New York, Förenta staterna, 10595
    - Indragen
    - Westchester Medical Center
- North Carolina
  - Durham, North Carolina, Förenta staterna, 27710
    - Rekrytering
    - Duke University Hospital
    - Kontakt:
      
      Rosanna Escobar-Spadina
      
      E-post: rosanna.escobar@duke.edu
    - Huvudutredare:
      
      Alexander Limkakeng, MD, MHSc
    - Kontakt:
      
      Alexander Limkakeng, MD, MHSc
      
      E-post: alexander.limkakeng@duke.edu
  - Winston-Salem, North Carolina, Förenta staterna, 27157
    - Avslutad
    - Wake Forest Baptist Medical Center
- Ohio
  - Cincinnati, Ohio, Förenta staterna, 45267
    - Rekrytering
    - University of Cincinnati Medical Center
    - Huvudutredare:
      
      Yasmin Aziz, MD
    - Kontakt:
      
      Yasmin Aziz, MD
      
      E-post: azizyn@ucmail.uc.edu
  - Columbus, Ohio, Förenta staterna, 43210
    - Rekrytering
    - OSU Wexner Medical Center
    - Huvudutredare:
      
      Jan Bittar, MD
    - Kontakt:
      
      Jan Bittar, MD
      
      E-post: jan.bittar@osumc.edu
- Oklahoma
  - Tulsa, Oklahoma, Förenta staterna, 74104
    - Rekrytering
    - Ascension St. John
    - Huvudutredare:
      
      Rahul Rahangdale, MD
    - Kontakt:
      
      Rahul Rahangdale, MD
      
      E-post: rahul.rahangdale@ascension.org
- Oregon
  - Portland, Oregon, Förenta staterna, 97225
    - Rekrytering
    - Providence St. Vincent Medical Center
    - Huvudutredare:
      
      Kishan Patel, MD
    - Kontakt:
      
      Kishan Patel, MD
      
      E-post: kishan.patel@providence.org
- Pennsylvania
  - Bethlehem, Pennsylvania, Förenta staterna, 18015
    - Rekrytering
    - Saint Luke's Hospital of Bethlehem Pennsylvania
    - Huvudutredare:
      
      Daniel Ackerman, MD
    - Kontakt:
      
      Daniel Ackerman, MD
      
      E-post: Daniel.Ackerman@sluhn.org
  - Philadelphia, Pennsylvania, Förenta staterna, 19140
    - Rekrytering
    - Temple University Hospital
    - Kontakt:
      
      Nina Gentile, MD
      
      E-post: ngentile@temple.edu
    - Huvudutredare:
      
      Nina Gentile, MD
- Rhode Island
  - Providence, Rhode Island, Förenta staterna, 02903
    - Rekrytering
    - Rhode Island Hospital
    - Huvudutredare:
      
      Farhan Khan, MD
    - Kontakt:
      
      Farhan Khan, MD
      
      E-post: fkhan@brownhealth.org
- South Carolina
  - Charleston, South Carolina, Förenta staterna, 32608
    - Rekrytering
    - Medical University of South Carolina University Hospital
    - Kontakt:
      
      Caitlan LeMatty
      
      E-post: lemattyc@musc.edu
    - Kontakt:
      
      Christine Holmstedt, DO
      
      E-post: holmsted@musc.edu
    - Huvudutredare:
      
      Christine Holmstedt, DO
  - Greenville, South Carolina, Förenta staterna, 29605
    - Rekrytering
    - Prisma Health Greenville Memorial
    - Kontakt:
      
      Sanjeev Sivakumar, MD
      
      E-post: Sanjeev.Sivakumar@prismahealth.org
    - Huvudutredare:
      
      Sanjeev Sivakumar, MD
- Tennessee
  - Memphis, Tennessee, Förenta staterna, 38104
    - Rekrytering
    - Methodist University Hospital
    - Kontakt:
      
      Quentin Thacker
      
      E-post: qthacker@uthsc.edu
    - Huvudutredare:
      
      Balaji Krishnaiah, MD
    - Kontakt:
      
      Balaji Krishnaiah, MD
      
      E-post: bkrishn4@uthsc.edu
- Texas
  - Houston, Texas, Förenta staterna, 77030
    - Rekrytering
    - Memorial Hermann Texas Medical Center
    - Kontakt:
      
      Andrew Barreto, MD, MS
      
      E-post: andrew.d.barreto@uth.tmc.edu
    - Kontakt:
      
      Prasen Marella
      
      E-post: prasen.r.marella@uth.tmc.edu
    - Huvudutredare:
      
      Andrew Barreto, MD, MS
- Utah
  - Salt Lake City, Utah, Förenta staterna, 84132
    - Indragen
    - University of Utah Healthcare
- Virginia
  - Charlottesville, Virginia, Förenta staterna, 22901
    - Rekrytering
    - UVA Medical Center
    - Huvudutredare:
      
      Amna Sohail, MBBS, MD
    - Kontakt:
      
      Amna Sohail, MBBS, MD
      
      E-post: ZRX5FU@uvahealth.org
  - Richmond, Virginia, Förenta staterna, 23298
    - Indragen
    - VCU Medical Center
- Washington
  - Seattle, Washington, Förenta staterna, 98104
    - Indragen
    - Harborview Medical Center
- Wisconsin
  - Milwaukee, Wisconsin, Förenta staterna, 53211
    - Rekrytering
    - Ascension Columbia St. Mary's Hospital
    - Kontakt:
      
      Lakiesha Coleman
      
      E-post: lakiesha.coleman@ascension.org
    - Kontakt:
      
      William Taylor, DO
      
      E-post: william.taylor3@ascension.org
    - Huvudutredare:
      
      William Taylor, DO

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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:
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%).
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.
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.
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:
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.
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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Primärt syfte: Behandling
Tilldelning: Randomiserad
Interventionsmodell: Parallellt uppdrag
Maskning: Fyrdubbla

Antal vapen

Vapen och interventioner

Deltagargrupp / Arm	Intervention / Behandling
Placebo-jämförare: Placebo Placebo	Biologisk: TS23 Monoclonal antibody
Experimentell: Dose 1 TS23 low dose	Biologisk: TS23 Monoclonal antibody
Experimentell: Dose 2 TS23 next higher dose	Biologisk: TS23 Monoclonal antibody
Experimentell: Dose 3 TS23 next higher dose	Biologisk: TS23 Monoclonal antibody
Experimentell: Dose 4 TS23 highest dose	Biologisk: TS23 Monoclonal antibody

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
The proportion of patients with ANY intracerebral hemorrhage (ICH) Tidsram: At 30 (+/- 4) hours after study drug	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) Tidsram: At 30 (+/- 4) hours after study drug	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

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Improvement in level of global disability measured by modified Rankin Score (mRS distribution) Tidsram: 90 (±7) days	The modified Rankin Score assessment is a 7-level disability scale that measures the degree of disability or dependence in daily activities of people who have suffered a stroke. Range 0= no disability and 6=dead.	90 (±7) days
Frequency of Modified Rankin (mRS) score of 0-1 or returning to pre-stroke mRS. Tidsram: Proportion of patients with modified Rankin scale score 0-1 or return to pre-stroke mRS at 90 (+/-7) days.	Proportion of patients with modified Rankin scale score 0-1 or return 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 Tidsram: 72 (±12) hours (or at discharge if sooner) after study drug administration.	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.	72 (±12) hours (or at discharge if sooner) after study drug administration.
α2-antiplasmin (a2AP) level in plasma Tidsram: at 3 (±1) h after completion of study drug administration	A serine protease inhibitor responsible for inactivating plasmin.	at 3 (±1) h after completion of study drug administration
Matrix metalloproteinase-9 level in plasma Tidsram: 3 (±1) h after completion of study drug	An enzyme that regulates the pathological remodeling process that involve inflammation and fibrosis associated with cardiovascular disease.	3 (±1) h after completion of study drug
% brain tissue reperfusion Tidsram: 30 (±4) h after study drug administration	Proportion of brain tissue that is reperfused on the follow-up perfusion scan compared to the baseline, calculated as: ([baseline minus follow up perfusion imaging area of hypoperfusion]/ baseline area of hypoperfusion); hypoperfusion=T max>6 seconds	30 (±4) h after study drug administration
Pharmacokinetic analyses Tidsram: 3 (±1) h, 30 (±4) h, 30 (±5) days & 90 (±7) days after study drug administration. At 90 (±7) days for approximately 50 mITT participants. After approximately 50 mITT participants, it will be obtained at 72h(+12 hrs)/discharge visit, whichever comes 1st.	Measure of plasma concentrations of TS23	3 (±1) h, 30 (±4) h, 30 (±5) days & 90 (±7) days after study drug administration. At 90 (±7) days for approximately 50 mITT participants. After approximately 50 mITT participants, it will be obtained at 72h(+12 hrs)/discharge visit, whichever comes 1st.
Evaluation of anti-drug antibodies Tidsram: will be measured at baseline and 90 (±7) days follow-up visit for approximately 50 mITT participants.	commonly used for characterization of therapeutic antibodies	will be measured at baseline and 90 (±7) days follow-up visit for approximately 50 mITT participants.
Proportion of patients with symptomatic intracerebral hemorrhage Tidsram: 30 (±4) h of study drug administration	a blood clot large enough to cause significant neurological deterioration.	30 (±4) h of study drug administration
Proportion of patients with non-intracerebral hemorrhage major or clinically relevant non-major bleeding Tidsram: 30 days of study drug administration.	major and non-major events of bleeding that is not in the brain	30 days of study drug administration.
Plasma fibrinogen level Tidsram: 3 (±1) h after completion of study drug	Clotting factor	3 (±1) h after completion of study drug
Proportion of patients with non-bleeding severe adverse events Tidsram: 90 (±7) days	Assessment of untoward events	90 (±7) days
Proportion of patients with stroke-related and all-cause deaths Tidsram: 90 (±7) days	measure of important patient outcomes	90 (±7) days

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Translational Sciences, Inc.

Samarbetspartners

Medical University of South Carolina

National Institute of Neurological Disorders and Stroke (NINDS)

University of Cincinnati

University of Arizona

Utredare

Huvudutredare: Eva Mistry, MBBS, University of Cincinnati

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

18 mars 2024

Primärt slutförande (Beräknad)

1 juli 2028

Avslutad studie (Beräknad)

1 december 2028

Studieregistreringsdatum

Först inskickad

8 juli 2023

Först inskickad som uppfyllde QC-kriterierna

8 juli 2023

Första postat (Faktisk)

17 juli 2023

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

19 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

TS23-U202
UH3NS125023 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

IPD-planbeskrivning

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."

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

STRATEGI FÖR ATT FÖRBÄTTRA STROKEBEHANDLINGENS SVAR (SISTER)

Studieöversikt

Status

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Studietyp

Inskrivning (Beräknad)

Fas

Kontakter och platser

Studiekontakt

Studera Kontakt Backup

Studieorter

Deltagandekriterier

Urvalskriterier

Åldrar som är berättigade till studier

Tar emot friska volontärer

Kön som är behöriga för studier

Beskrivning

Studieplan

Hur är studien utformad?

Designdetaljer

Antal vapen

Vapen och interventioner

Deltagargrupp / Arm

Intervention / Behandling

Vad mäter studien?

Primära resultatmått

Resultatmått

Åtgärdsbeskrivning

Tidsram

Sekundära resultatmått

Resultatmått

Åtgärdsbeskrivning

Tidsram

Samarbetspartners och utredare

Sponsor

Samarbetspartners

Utredare

Studieavstämningsdatum

Studera stora datum

Studiestart (Faktisk)

Primärt slutförande (Beräknad)

Avslutad studie (Beräknad)

Studieregistreringsdatum

Först inskickad

Först inskickad som uppfyllde QC-kriterierna

Första postat (Faktisk)

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

Senast verifierad

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

IPD-planbeskrivning

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Studerar en amerikansk FDA-reglerad produktprodukt