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뇌졸중 치료 반응 개선을 위한 전략 (SISTER)

2026년 10월 13일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

300

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 미국
    • Alabama
      • Birmingham, Alabama, 미국, 35233
        • 모병
        • University of Alabama Hospital
        • 연락하다:
        • 수석 연구원:
          • Felix Guerra Castanon, MD
    • Arizona
      • Phoenix, Arizona, 미국, 85006
        • 모병
        • Banner University Medical Center
        • 수석 연구원:
          • Savdeep Singh, MD
        • 연락하다:
      • Phoenix, Arizona, 미국, 85054
        • 빼는
        • Mayo Clinic Phoenix
      • Tucson, Arizona, 미국, 85719
        • 모병
        • Banner University Medical Center - Tucson
        • 연락하다:
        • 수석 연구원:
          • Firas Kaddouh, MD, MHS
    • California
      • La Jolla, California, 미국, 92093
      • Los Angeles, California, 미국, 90027
        • 모병
        • Kaiser Permanente Los Angeles
        • 연락하다:
        • 수석 연구원:
          • Navdeep Sangha, MD
      • Sacramento, California, 미국, 95816
        • 빼는
        • Sutter Medical Center
      • San Diego, California, 미국, 92103
        • 모병
        • UCSD Medical Center- Hillcrest Hospital
        • 연락하다:
        • 수석 연구원:
          • Royya Modir, MD
        • 연락하다:
    • Connecticut
      • Hartford, Connecticut, 미국, 06102
      • New Haven, Connecticut, 미국, 06511
        • 모병
        • Yale New Haven Hospital
        • 연락하다:
        • 수석 연구원:
          • James Giles, MD, PhD
    • Delaware
      • Newark, Delaware, 미국, 19718
        • 빼는
        • Christiana Hospital
    • Florida
      • Gainesville, Florida, 미국, 32608
        • 종료됨
        • UF Health Shands Hospital
      • Miami, Florida, 미국, 33136
        • 모병
        • Jackson Memorial Hospital
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Gillian Gordon Perue, MD, MBBS, DM
    • Georgia
      • Atlanta, Georgia, 미국, 30303
        • 모병
        • Grady Memorial Hospital
        • 연락하다:
        • 수석 연구원:
          • Nicolas Bianchi, MD
    • Illinois
      • Chicago, Illinois, 미국, 60637
        • 모집하지 않고 적극적으로
        • University of Chicago Medical Center
    • Iowa
      • Iowa City, Iowa, 미국, 52242
        • 빼는
        • University of Iowa Hospitals & Clinics
    • Kentucky
      • Lexington, Kentucky, 미국, 40503
      • Louisville, Kentucky, 미국, 40202
        • 모병
        • University of Louisville Hospital
        • 수석 연구원:
          • Isaac Abecassis, MD
        • 연락하다:
    • Massachusetts
      • Boston, Massachusetts, 미국, 02115
        • 모병
        • Brigham and Women's Hospital
        • 수석 연구원:
          • Rahul Mahajan, MD, PhD
        • 연락하다:
      • Boston, Massachusetts, 미국, 02171
        • 모병
        • Massachusetts General Hospital
        • 수석 연구원:
          • Aneesh Singhal, MD, MBBS
        • 연락하다:
    • Minnesota
      • Burnsville, Minnesota, 미국, 55337
        • 모병
        • M Health Fairview Ridges Hospital
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Muhammad Affan, MD, MBBS
      • Edina, Minnesota, 미국, 55435
        • 모병
        • M Health Fairview Southdale Hospital
        • 연락하다:
        • 수석 연구원:
          • Muhammad Affan, MD, MBBS
        • 연락하다:
      • Minneapolis, Minnesota, 미국, 55455
        • 모병
        • M Health Fairview University of Minnesota Medical Center
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Muhammad Affan, MD,MBBS
      • Saint Paul, Minnesota, 미국, 55102
        • 빼는
        • United Hospital
    • Missouri
      • St Louis, Missouri, 미국, 63110
        • 모병
        • Barnes Jewish Hospital
        • 수석 연구원:
          • Charles Kircher, MD
        • 연락하다:
    • New Jersey
      • Edison, New Jersey, 미국, 08837
        • 모병
        • JFK Medical Center
        • 수석 연구원:
          • Nancy Gadallah, DO
        • 연락하다:
    • New York
      • Brooklyn, New York, 미국, 11220
      • Buffalo, New York, 미국, 14203
        • 빼는
        • Buffalo General Medical Center
      • Manhasset, New York, 미국, 11030
      • New York, New York, 미국, 10029
        • 모병
        • The Mount Sinai Hospital
        • 연락하다:
        • 수석 연구원:
          • Laura Stein, MD, MPH
      • New York, New York, 미국, 10032
      • New York, New York, 미국, 10029
        • 빼는
        • Mount Sinai West
      • Syracuse, New York, 미국, 13202
        • 모병
        • SUNY Upstate Medical University
        • 연락하다:
        • 수석 연구원:
          • Julius-Gene LaTorre, MD, MPH
        • 연락하다:
      • Valhalla, New York, 미국, 10595
        • 빼는
        • Westchester Medical Center
    • North Carolina
      • Durham, North Carolina, 미국, 27710
      • Winston-Salem, North Carolina, 미국, 27157
        • 종료됨
        • Wake Forest Baptist Medical Center
    • Ohio
      • Cincinnati, Ohio, 미국, 45267
        • 모병
        • University of Cincinnati Medical Center
        • 수석 연구원:
          • Yasmin Aziz, MD
        • 연락하다:
      • Columbus, Ohio, 미국, 43210
        • 모병
        • OSU Wexner Medical Center
        • 수석 연구원:
          • Jan Bittar, MD
        • 연락하다:
    • Oklahoma
      • Tulsa, Oklahoma, 미국, 74104
    • Oregon
      • Portland, Oregon, 미국, 97225
        • 모병
        • Providence St. Vincent Medical Center
        • 수석 연구원:
          • Kishan Patel, MD
        • 연락하다:
    • Pennsylvania
      • Bethlehem, Pennsylvania, 미국, 18015
        • 모병
        • Saint Luke's Hospital of Bethlehem Pennsylvania
        • 수석 연구원:
          • Daniel Ackerman, MD
        • 연락하다:
      • Philadelphia, Pennsylvania, 미국, 19140
        • 모병
        • Temple University Hospital
        • 연락하다:
        • 수석 연구원:
          • Nina Gentile, MD
    • Rhode Island
      • Providence, Rhode Island, 미국, 02903
        • 모병
        • Rhode Island Hospital
        • 수석 연구원:
          • Farhan Khan, MD
        • 연락하다:
    • South Carolina
      • Charleston, South Carolina, 미국, 32608
        • 모병
        • Medical University of South Carolina University Hospital
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Christine Holmstedt, DO
      • Greenville, South Carolina, 미국, 29605
    • Tennessee
      • Memphis, Tennessee, 미국, 38104
        • 모병
        • Methodist University Hospital
        • 연락하다:
        • 수석 연구원:
          • Balaji Krishnaiah, MD
        • 연락하다:
    • Texas
    • Utah
      • Salt Lake City, Utah, 미국, 84132
        • 빼는
        • University of Utah Healthcare
    • Virginia
      • Charlottesville, Virginia, 미국, 22901
        • 모병
        • UVA Medical Center
        • 수석 연구원:
          • Amna Sohail, MBBS, MD
        • 연락하다:
      • Richmond, Virginia, 미국, 23298
        • 빼는
        • VCU Medical Center
    • Washington
      • Seattle, Washington, 미국, 98104
        • 빼는
        • Harborview Medical Center
    • Wisconsin

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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. Anticipate being 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.

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: Placebo

Placebo
생물학적: TS23

Monoclonal antibody
실험적: Dose 1 TS23

low dose
생물학적: TS23

Monoclonal antibody
실험적: Dose 2 TS23

next higher dose
생물학적: TS23

Monoclonal antibody
실험적: Dose 3 TS23

next higher dose
생물학적: TS23

Monoclonal antibody
실험적: Dose 4 TS23

highest dose
생물학적: TS23

Monoclonal antibody

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
The proportion of patients with ANY intracerebral hemorrhage (ICH)
기간: 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)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Improvement in level of global disability measured by modified Rankin Score (mRS distribution)
기간: 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.
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 90 (±7) days

Assessment of untoward events
90 (±7) days
Proportion of patients with stroke-related and all-cause deaths
기간: 90 (±7) days

measure of important patient outcomes
90 (±7) days

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Translational Sciences, Inc.

협력자

Medical University of South Carolina
National Institute of Neurological Disorders and Stroke (NINDS)
University of Cincinnati
University of Arizona

수사관

  • 수석 연구원: Eva Mistry, MBBS, University of Cincinnati

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 3월 18일

기본 완료 (추정된)

2028년 7월 1일

연구 완료 (추정된)

2028년 12월 1일

연구 등록 날짜

최초 제출

2023년 7월 8일

QC 기준을 충족하는 최초 제출

2023년 7월 8일

처음 게시됨 (실제)

2023년 7월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 19일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 13일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • TS23-U202
  • UH3NS125023 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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."

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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