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STRATEGI TIL FORBEDRING AF BEHANDLING AF SLAG TIL SLAG (SISTER)

13. oktober 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Iskæmisk slagtilfælde

Intervention / Behandling

Biologisk: TS23

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

300

Fase

Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

Undersøgelse Kontakt Backup

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

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm Deltagergruppe / Arm En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.	Intervention / Behandling Intervention / Behandling En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Placebo komparator: Placebo Placebo	Biologisk: TS23 Monoclonal antibody
Eksperimentel: Dose 1 TS23 low dose	Biologisk: TS23 Monoclonal antibody
Eksperimentel: Dose 2 TS23 next higher dose	Biologisk: TS23 Monoclonal antibody
Eksperimentel: Dose 3 TS23 next higher dose	Biologisk: TS23 Monoclonal antibody
Eksperimentel: Dose 4 TS23 highest dose	Biologisk: TS23 Monoclonal antibody

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
The proportion of patients with ANY intracerebral hemorrhage (ICH) Tidsramme: 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) Tidsramme: 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

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Improvement in level of global disability measured by modified Rankin Score (mRS distribution) Tidsramme: 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. Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 90 (±7) days	Assessment of untoward events	90 (±7) days
Proportion of patients with stroke-related and all-cause deaths Tidsramme: 90 (±7) days	measure of important patient outcomes	90 (±7) days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Translational Sciences, Inc.

Samarbejdspartnere

Medical University of South Carolina

National Institute of Neurological Disorders and Stroke (NINDS)

University of Cincinnati

University of Arizona

Efterforskere

Ledende efterforsker: Eva Mistry, MBBS, University of Cincinnati

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. marts 2024

Primær færdiggørelse (Anslået)

1. juli 2028

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

8. juli 2023

Først indsendt, der opfyldte QC-kriterier

8. juli 2023

Først opslået (Faktiske)

17. juli 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

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."

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

STRATEGI TIL FORBEDRING AF BEHANDLING AF SLAG TIL SLAG (SISTER)

Studieoversigt

Status

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Undersøgelsestype

Tilmelding (Anslået)

Fase

Kontakter og lokationer

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Samarbejdspartnere

Efterforskere

Datoer for undersøgelser

Studer store datoer

Studiestart (Faktiske)

Primær færdiggørelse (Anslået)

Studieafslutning (Anslået)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Faktiske)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt