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STRATEGIE VOOR HET VERBETEREN VAN DE REACTIE OP DE BEHANDELING VAN EEN SLAG (SISTER)

13 oktober 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Ischemische beroerte

Interventie / Behandeling

Biologisch: TS23

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Geschat)

300

Fase

Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

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

Studie Contact Back-up

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

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Behandeling
Toewijzing: Gerandomiseerd
Interventioneel model: Parallelle opdracht
Masker: Verviervoudigen

Aantal wapens

Wapens en interventies

Deelnemersgroep / Arm	Interventie / Behandeling
Placebo-vergelijker: Placebo Placebo	Biologisch: TS23 Monoclonal antibody
Experimenteel: Dose 1 TS23 low dose	Biologisch: TS23 Monoclonal antibody
Experimenteel: Dose 2 TS23 next higher dose	Biologisch: TS23 Monoclonal antibody
Experimenteel: Dose 3 TS23 next higher dose	Biologisch: TS23 Monoclonal antibody
Experimenteel: Dose 4 TS23 highest dose	Biologisch: TS23 Monoclonal antibody

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
The proportion of patients with ANY intracerebral hemorrhage (ICH) Tijdsspanne: 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) Tijdsspanne: 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

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Translational Sciences, Inc.

Medewerkers

Medical University of South Carolina

National Institute of Neurological Disorders and Stroke (NINDS)

University of Cincinnati

University of Arizona

Onderzoekers

Hoofdonderzoeker: Eva Mistry, MBBS, University of Cincinnati

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

18 maart 2024

Primaire voltooiing (Geschat)

1 juli 2028

Studie voltooiing (Geschat)

1 december 2028

Studieregistratiedata

Eerst ingediend

8 juli 2023

Eerst ingediend dat voldeed aan de QC-criteria

8 juli 2023

Eerst geplaatst (Werkelijk)

17 juli 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

13 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

TS23-U202
UH3NS125023 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Beschrijving IPD-plan

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."

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

STRATEGIE VOOR HET VERBETEREN VAN DE REACTIE OP DE BEHANDELING VAN EEN SLAG (SISTER)

Studie Overzicht

Toestand

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Studietype

Inschrijving (Geschat)

Fase

Contacten en locaties

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Accepteert gezonde vrijwilligers

Geslachten die in aanmerking komen voor studie

Beschrijving

Studie plan

Hoe is de studie opgezet?

Ontwerpdetails

Aantal wapens

Wapens en interventies

Deelnemersgroep / Arm

Interventie / Behandeling

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat

Maatregel Beschrijving

Tijdsspanne

Secundaire uitkomstmaten

Uitkomstmaat

Maatregel Beschrijving

Tijdsspanne

Medewerkers en onderzoekers

Sponsor

Medewerkers

Onderzoekers

Studie record data

Bestudeer belangrijke data

Studie start (Werkelijk)

Primaire voltooiing (Geschat)

Studie voltooiing (Geschat)

Studieregistratiedata

Eerst ingediend

Eerst ingediend dat voldeed aan de QC-criteria

Eerst geplaatst (Werkelijk)

Updates van studierecords

Laatste update geplaatst (Werkelijk)

Laatste update ingediend die voldeed aan QC-criteria

Laatst geverifieerd

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Beschrijving IPD-plan

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct