Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New antibody could reduce bleeding after stroke

NCT ID NCT05948566

Disease control Sponsor: Translational Sciences, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times

Summary

This study tests a new drug called TS23, an antibody that may help people recover from ischemic strokes by lowering the chance of bleeding in the brain. The trial involves 300 adults who have had a stroke and will receive either the drug or a placebo. Researchers will check for bleeding and measure stroke severity to see if the drug is safe and effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TS23 (monoclonal antibody)
What this could lead to
If successful, this could lead to a new treatment that helps people recover better from ischemic strokes by reducing the risk of bleeding in the brain.
What could go wrong
This is an early Phase 2 trial, so the drug may not prove safe or effective. There is also a risk that the antibody could cause bleeding or other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18 years and older 2. Suspected anterior circulation acute ischemic stroke 3. NIH Stroke Scale score ≥4 prior to randomization a. The participant must have a clearly disabling deficit if NIHSS is 4-5. 4. 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%). 5. Able to receive assigned study drug within 4.5 to 24 hours of stroke onset or last known well. 6. Able to receive assigned study drug within 120 minutes of qualifying perfusion imaging. \* 7. Informed consent for the study participation obtained from participant or their legally authorized representatives. * Study drug administration is encouraged within 90 minutes after qualifying perfusion image but is allowed up to 120 minutes. After 120 minutes, another perfusion image to ensure that inclusion criteria are met is required. Exclusion Criteria: 1. 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. 2. Received or planned to receive intravenous thrombolysis. 3. Pre-stroke modified Rankin score \>2. 4. Previous treatment with TS23 or known previous allergy to antibody therapy. 5. 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. 6. Known previous stroke in the past 90 days. 7. Known previous intracranial hemorrhage, intracranial neoplasm, subarachnoid hemorrhage, or arterial venous malformation. 8. Known active diagnosis of intracranial neoplasm. 9. Clinical presentation suggestive of a subarachnoid hemorrhage, even if initial CT scan was normal. 10. Surgery or biopsy of parenchymal organ in the past 30 days. 11. Known trauma with internal injuries or persistent ulcerative wounds in the past 30 days. 12. Severe head trauma in the past 90 days. 13. Persistent systolic blood pressure \>180mmHg or diastolic blood pressure \>105mmHg despite best medical management. 14. Serious systemic hemorrhage in the past 30 days. 15. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with International Normalized Ratio (INR) \>1.7. 16. Platelets \<100,000/mm3. 17. Hematocrit \<25 %. 18. Elevated aPTT above laboratory upper limit of normal. 19. Creatinine \> 4 mg/dl, or patients receiving renal dialysis, regardless of creatinine. 20. 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. 21. Received Factor Xa inhibitors (such as Fondaparinux, apixaban or rivaroxaban) within the past 48 hours. 22. Received direct thrombin inhibitors (e.g., argatroban, dabigatran, bivalirudin, desirudin, lepirudin) within 48 hours. 23. Received glycoprotein IIb/IIIa inhibitors within the past 14 days. 24. Known pre-existing neurological or psychiatric disease which would confound the neurological/functional evaluations. 25. Current participation in another research drug treatment protocol (i.e., participants could not start another experimental agent until after 90 days). 26. Concurrent acute myocardial infarction, pulmonary embolism, deep venous thrombosis or other thrombotic event that requires anticoagulation or anti-platelet treatment.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Ischemic stroke are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

ischemic stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ischemic stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    40 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ascension Columbia St. Mary's Hospital

    RECRUITING

    Milwaukee, Wisconsin, 53211, United States

  • Ascension St. John

    RECRUITING

    Tulsa, Oklahoma, 74104, United States

  • Banner University Medical Center

    RECRUITING

    Phoenix, Arizona, 85006, United States

  • Banner University Medical Center - Tucson

    RECRUITING

    Tucson, Arizona, 85719, United States

  • Baptist Healthcare System, Inc.

    RECRUITING

    Lexington, Kentucky, 40503, United States

  • Barnes Jewish Hospital

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Buffalo General Medical Center

    WITHDRAWN

    Buffalo, New York, 14203, United States

  • Christiana Hospital

    ACTIVE_NOT_RECRUITING

    Newark, Delaware, 19718, United States

  • Duke University Hospital

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Grady Memorial Hospital

    RECRUITING

    Atlanta, Georgia, 30303, United States

  • Harborview Medical Center

    ACTIVE_NOT_RECRUITING

    Seattle, Washington, 98104, United States

  • Hartford Hospital

    RECRUITING

    Hartford, Connecticut, 06102, United States

  • JFK Medical Center

    RECRUITING

    Edison, New Jersey, 08837, United States

  • Jackson Memorial Hospital

    RECRUITING

    Miami, Florida, 33136, United States

  • Kaiser Permanente Los Angeles

    RECRUITING

    Los Angeles, California, 90027, United States

  • M Health Fairview Ridges Hospital

    RECRUITING

    Burnsville, Minnesota, 55337, United States

  • M Health Fairview Southdale Hospital

    RECRUITING

    Edina, Minnesota, 55435, United States

  • M Health Fairview University of Minnesota Medical Center

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02171, United States

  • Mayo Clinic Phoenix

    WITHDRAWN

    Phoenix, Arizona, 85054, United States

  • Medical University of South Carolina University Hospital

    RECRUITING

    Charleston, South Carolina, 32608, United States

  • Memorial Hermann Texas Medical Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Methodist University Hospital

    RECRUITING

    Memphis, Tennessee, 38104, United States

  • Mount Sinai West

    RECRUITING

    New York, New York, 10029, United States

  • NYP Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • NYU Langone Health

    RECRUITING

    Brooklyn, New York, 11220, United States

  • North Shore University Hospital

    RECRUITING

    Manhasset, New York, 11030, United States

    Contact Email: •••••@•••••

  • OSU Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Prisma Health Greenville Memorial

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • Providence St. Vincent Medical Center

    RECRUITING

    Portland, Oregon, 97225, United States

  • Rhode Island Hospital

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • SUNY Upstate Medical University

    RECRUITING

    Syracuse, New York, 13202, United States

  • Saint Luke's Hospital of Bethlehem Pennsylvania

    RECRUITING

    Bethlehem, Pennsylvania, 18015, United States

  • Sutter Medical Center

    WITHDRAWN

    Sacramento, California, 95816, United States

  • Temple University Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • The Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

  • UCSD Health La Jolla

    RECRUITING

    La Jolla, California, 92093, United States

  • UCSD Medical Center- Hillcrest Hospital

    RECRUITING

    San Diego, California, 92103, United States

  • UF Health Shands Hospital

    TERMINATED

    Gainesville, Florida, 32608, United States

  • UVA Medical Center

    RECRUITING

    Charlottesville, Virginia, 22901, United States

  • United Hospital

    WITHDRAWN

    Saint Paul, Minnesota, 55102, United States

  • University of Alabama Hospital

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Cincinnati Medical Center

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • University of Iowa Hospitals & Clinics

    WITHDRAWN

    Iowa City, Iowa, 52242, United States

  • University of Louisville Hospital

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of Utah Healthcare

    WITHDRAWN

    Salt Lake City, Utah, 84132, United States

  • VCU Medical Center

    WITHDRAWN

    Richmond, Virginia, 23298, United States

  • Wake Forest Baptist Medical Center

    TERMINATED

    Winston-Salem, North Carolina, 27157, United States

  • Westchester Medical Center

    WITHDRAWN

    Valhalla, New York, 10595, United States

  • Yale New Haven Hospital

    RECRUITING

    New Haven, Connecticut, 06511, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.