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STRATEGI FOR FORBEDRING AV SJUKBEHANDLINGSRESPONS (SISTER)

13. oktober 2026 oppdatert 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.

Studieoversikt

Status

Rekruttering

Forhold

Iskemisk hjerneslag

Intervensjon / Behandling

Biologisk: TS23

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

300

Fase

Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

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

Studer Kontakt Backup

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

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: Randomisert
Intervensjonsmodell: Parallell tildeling
Masking: Firemannsrom

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm	Intervensjon / Behandling
Placebo komparator: Placebo Placebo	Biologisk: TS23 Monoclonal antibody
Eksperimentell: Dose 1 TS23 low dose	Biologisk: TS23 Monoclonal antibody
Eksperimentell: Dose 2 TS23 next higher dose	Biologisk: TS23 Monoclonal antibody
Eksperimentell: Dose 3 TS23 next higher dose	Biologisk: TS23 Monoclonal antibody
Eksperimentell: Dose 4 TS23 highest dose	Biologisk: TS23 Monoclonal antibody

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	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	Tiltaksbeskrivelse	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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Translational Sciences, Inc.

Samarbeidspartnere

Medical University of South Carolina

National Institute of Neurological Disorders and Stroke (NINDS)

University of Cincinnati

University of Arizona

Etterforskere

Hovedetterforsker: Eva Mistry, MBBS, University of Cincinnati

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

18. mars 2024

Primær fullføring (Antatt)

1. juli 2028

Studiet fullført (Antatt)

1. desember 2028

Datoer for studieregistrering

Først innsendt

8. juli 2023

Først innsendt som oppfylte QC-kriteriene

8. juli 2023

Først lagt ut (Faktiske)

17. juli 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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."

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

STRATEGI FOR FORBEDRING AV SJUKBEHANDLINGSRESPONS (SISTER)

Studieoversikt

Status

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Studietype

Registrering (Antatt)

Fase

Kontakter og plasseringer

Studiekontakt

Studer Kontakt Backup

Studiesteder

Deltakelseskriterier

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Tar imot friske frivillige

Kjønn som er kvalifisert for studier

Beskrivelse

Studieplan

Hvordan er studiet utformet?

Designdetaljer

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm

Intervensjon / Behandling

Hva måler studien?

Primære resultatmål

Resultatmål

Tiltaksbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Tiltaksbeskrivelse

Tidsramme

Samarbeidspartnere og etterforskere

Sponsor

Samarbeidspartnere

Etterforskere

Studierekorddatoer

Studer hoveddatoer

Studiestart (Faktiske)

Primær fullføring (Antatt)

Studiet fullført (Antatt)

Datoer for studieregistrering

Først innsendt

Først innsendt som oppfylte QC-kriteriene

Først lagt ut (Faktiske)

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Sist bekreftet

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

IPD-planbeskrivelse

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Studerer et amerikansk FDA-regulert enhetsprodukt