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Thrombolysis Treated With TNK-tPA in Acute Ischemic Stroke Patients （3T Stroke-Ⅲ）

Sponsor
Beijing Tiantan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05745259
Collaborator
Jiangsu FENG HUA Biotech Pharmaceutical Co., Ltd (Other), The Place Pharmaceutical(Jiangsu) Co., Ltd (Other)
1,630
Enrollment
63
Locations
2
Arms
17.1
Anticipated Duration (Months)
25.9
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The trial is prospective, randomized, open-label, blinded endpoint (PROBE) design. Patients with acute ischemic stroke, who are eligible for standard intravenous thrombolysis within 4.5 hours of stroke onset will be randomized 1:1 to 0.25mg/kg or 0.9 mg/kg alteplase before all participants undergo endovascular thrombectomy.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

The study will be a multi-center, prospective, randomized, open- label, blinded endpoint (PROBE), controlled phase 3 trial (2 arm with 1:1 randomization) in ischemic stroke patients. Imagine is performed with CT or MRI acutely with imaging follow-up at 24-36 hours. The sample size is 1630.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1630 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Thrombolysis Treated by TNK-tPA in Acute Ischemic Stroke Patients: a Multi-center, Block Randomized, Positive Drug Parallel Control and Non-inferior Phase Ⅲ Trial, 3T Stroke-Ⅲ
Actual Study Start Date :
Oct 26, 2022
Anticipated Primary Completion Date :
Nov 4, 2023
Anticipated Study Completion Date :
Mar 29, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Alteplase

Patients will receive intravenous Alteplase at the standard licensed dose of 0.9 mg/kg up to a maximum of 90mg, 10% as bolus and the remainder over 1 hour.

Drug: Alteplase
Alteplase 0.9mg/kg are being used.
Other Names:
  • rt-PA

    		•
    Experimental: Tenecteplase

    Patients will receive intravenous Tenecteplase, 0.25mg/kg, maximum 25mg, administered as a bolus over 5~10 seconds

    Drug: Tenecteplase
    Tenecteplase 0.25mg/kg are being used.
    Other Names:
  • TNK-tPA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Modified Rankin Scale(mRS) [90±7 days]

      Proportion of subjects with mRS scores of (0-1) at 90±7 days.

    Secondary Outcome Measures

    1. National Institutes of Health Stroke Scale (NIHSS) [24±2 hours]

      NIHSS score at 24±2 hours.

    2. National Institutes of Health Stroke Scale (NIHSS) [7±2days or discharge]

      Proportion of subjects with ≥ 4 point reduction in NIHSS or reaching 0-1 at 7 ± 2 days or before discharge (whichever occurs first)

    3. Modified Rankin Scale(mRS) [90±7 days]

      Proportion of subjects with mRS scores of (0-2) at 90±7 days.

    4. Modified Rankin Scale(mRS) [90±7 days]

      mRS scores at 90±7 days.

    5. The new vascular events [90±7 days]

      Incidence of the new vascular events, ischemic stroke, hemorrhagic stroke, myocardial infarction and cardio-cerebral revascularization at 90±7 days. (including: carotid endarterectomy, intracranial and extracranial artery interventional therapy, intracranial and extracranial artery bypass surgery, coronary interventional or bypass therapy)

    6. EQ-5D [90±7 days]

      EQ-5D scores at 90±7 days.

    Other Outcome Measures

    1. Symptomatic intracranial hemorrhage(sICH) [24~36 hours post treatment]

      Incidence of symptomatic intracranial hemorrhage (sICH) within 24~36 hours.( According to ECASS Ⅲ and SITS-MOST)

    2. Parenchymal hematoma intracranial hemorrhage (type PH2, SITS-MOST) [24~36 hours post treatment]

      Incidence of intracranial hemorrhage (type PH2, SITS-MOST) within 24~36 hours.

    3. Any intracranial hemorrhage [24~36 hours post treatment]

      Incidence of any intracranial hemorrhage within 24~36 hours.

    4. Systematic bleeding [36 hours]

      Incidence of Systematic bleeding within 36 hours. (defined by GUSTO)

    5. Deaths [90±7 days]

      Vascular mortality at 90±7 days (mainly due to stroke, myocardial infarction or pulmonary embolism)

    6. Deaths [90±7 days]

      Mortality due to any cause at 90±7days.

    7. SAEs [90±7 days]

      Incidence of severe adverse events(SAEs) at 90±7 days.

    8. AEs [90±7 days]

      Incidence of adverse events(AEs) at 90±7 days.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18≤Age≤80 years old;

    • The clinical diagnosis was Acute ischemic stroke The time from onset to treatment was < 4.5h; The time at which symptoms begin is defined as "the time at which they finally appear normal";

    • MRS before onset was ≤1 points;

    • Baseline NIHSS (at the time of randomization) should be ≥5 and ≤25 points;

    • Informed consent from the patient or surrogate.

    Exclusion Criteria:

    • Intracranial hemorrhage identified by CT or MRI (CMBs detected by SWI is not counted);

    • Massive anterior cerebral infarction identified by CT or MRI (ASPECT < 6 or lesions larger than one third of the territory of the middle cerebral artery or with a volume larger than 70mL)

    • Patients planning to receive endovascular therapy

    • A history of severe CNS damage (such as aneurysm or arteriovenous malformation, craniocerebral trauma, intracranial or spinal cord surgery)

    • Onset with seizures, and the paralysis was suspected to be related to Todd paralysis.

    • Administration of heparin within 48 hours preceding the onset of stroke with a baseline APTT exceeding the upper limit of the normal range.

    • Oral anticoagulant (such as warfarin) treatment with baseline INR>1.7 or PT>15 s;

    • Administration of thrombin inhibitors or factor Xa inhibitors within 48 hours preceding the onset of stroke with abnormal coagulation parameters or platelet count;

    • BP couldn't be controlled with aggressive treatment. Uncontrolled hypertension was defined as systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, measured for three times every 10 minutes.

    • Platelet count of less than 100×109/ L;

    • Blood glucose <50 mg/dl (<2.8 mmol/L) or >400 mg/dl (22.22 mmol/L);

    • History of intracranial hemorrhage or active hemorrhagic disease. (Such as gastrointestinal, urinary tract or retinal bleeding)

    • Tumors with an increased risk of bleeding.

    • Prolonged or traumatic cardiopulmonary resuscitation (>2 min), delivery within the last 10 days or recent puncture of non-compression vessels such as subclavian vein or jugular vein

    • Acute pancreatitis or severe liver disease, including liver failure, cirrhosis, portal hypertension, esophageal varicose veins, and active hepatitis;

    • Aortic arch dissection;

    • Major surgery or severe trauma in the past 2 weeks;

    • Subjects had serious, fatal, or disabling disease with an expected survival of less than 3 months;

    • Unable to complete neurological assessment and follow-up visits because of dementia or mental illness;

    • Pregnant women, lactating women, or have positive pregnancy test;

    • Allergy to tenecteplase or alteplase or their components;

    • Participation in other clinical trials within 3 months prior to screening;

    • Unsuitable to involve in this study or would result in increased risk, as judged by the investigators.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xuancheng People's Hospital Xuancheng Anhui China 242000
    2 Beijing Tiantan Hospital, Capital Medical University Beijing Beijing Beijing China 100000
    3 Xuanwu Hospital Capital Medical University Beijing Beijing China 100053
    4 Three Gorges Hospital Affiliated to Chongqing University Chongqing Chongqing China 404100
    5 Quanzhou First Hospital Quanzhou Fujian China 362000
    6 Lanzhou University First Hospital Lanzhou Gansu China 730000
    7 The Third People's Hospital of Huizhou Huizhou Guangdong China 516000
    8 Yuebei People's Hospital Shaoguan Guangdong China 512000
    9 The First People's Hospital of Yulin Yulin Guangxi China 541000
    10 Handan Central Hospital Handan Hebei China 056000
    11 Hengshui people's Hospital (Harrison International Peace Hospital) Hengshui Hebei China 053000
    12 Tangshan Workers' Hospital Tangshan Hebei China 063000
    13 Daqing Oilfield General Hospital Daqing Heilongjiang China 163000
    14 Daqing People's Hospital Daqing Heilongjiang China 163000
    15 Anyang People's Hospital Anyang Henan China 455100
    16 Jiaozuo People's Hospital Jiaozuo Henan China 454000
    17 Nanyang South Stone Hospital Nanyang Henan China 473000
    18 Pingmei Shenma medical group general hospital Pingdingshan Henan China 467000
    19 Xinxiang Central Hospital Xinxiang Henan China 453000
    20 Zhoukou Downtown Hospital Zhoukou Henan China 466000
    21 The First People's Hospital of Jingzhou Jingzhou, Hubei China 434000
    22 Baogang Hospital of Inner Monglia Baotou Inner Monglia China 014010
    23 Baotou Central Hospital Baotou Inner Mongolia China 014010
    24 Keshenketengqi Mongolian Medicine Hospital Chifeng Inner Mongolia China 025300
    25 The Second Affiliated Hospital of Suzhou Medical University Suzhou Jiangsu China 215000
    26 Taizhou People's Hospital Taizhou Jiangsu China 225300
    27 Xuzhou Central Hospital Xuzhou Jiangsu China 221000
    28 Xuzhou Mining Group General Hospital Xuzhou Jiangsu China 221000
    29 The Affiliated Hospital of Xuhzou Meidcal University Xuzhou Jiangsu China 221006
    30 The First Hospital of Jilin University Changchun Jilin China 130021
    31 Jilin Guowen Hospital Siping Jilin China 136000
    32 Siping Central People's Hospital Siping Jilin China 136000
    33 Tonghua Central Hospital Tonghua Jilin China 134100
    34 Meihekou Central Hospital Tonghua Jilin China 135000
    35 Beipiao Central Hospital Beipiao Liaoning China 122000
    36 Dalian Central Hospital Dalian Liaoning China 116000
    37 Fushun Mining Bureau General Hospital Fushun Liaoning China 113000
    38 Liaoning Health Industry Group Fuxin Mine General Hospital Fuxin Liaoning China 123100
    39 The First Affiliated Hospital of Jinzhou Medical University Jinzhou Liaoning China 121000
    40 Affiliated Central Hospital of Shenyang Medical College ShenYang Liaoning China 111000
    41 Air Force Hospital of Northern War Zone,PLA Shenyang Liaoning China 111000
    42 General Hospital of Northern War Zone,PLA Shenyang Liaoning China 111000
    43 The First Affiliated Hospital of China Medical University ShenYang Liaoning China 111000
    44 The First People's Hospital of Shenyang Shenyang Liaoning China 111000
    45 General Hospital of Ningxia Medical University Cardio-cerebral Vascular Disease Hospital Yinchuan Ningxia China 750000
    46 The First People's Hospital of Yinchuan Yinchuan Ningxia China 750000
    47 Dezhou Hospital of Shandong University Qilu Hospital (Dezhou People's Hospital) Dezhou Shandong China 253000
    48 Jinan People's Hospital Jinan Shandong China 250000
    49 Qilu Hospital of Shandong University Jinan Shandong China 250012
    50 Liaocheng People's Hospital Liaocheng Shandong China 252006
    51 Linyi Hospital of Traditional Chinese Medicine Linyi Shandong China 273300
    52 Linyi People's Hospital Linyi Shandong China 273300
    53 The First People's Hospital of Tancheng County Linyi Shandong China 2761000
    54 Taian Central Hospital (Tai 'an Central Hospital of Qingdao University, Tai 'an Medical and Nursing Center) Taian Shandong China 271000
    55 Tengzhou Central Hospital Tengzhou Shandong China 277500
    56 Weifang Hospital of Traditional Chinese Medicine Weifang Shandong China 261000
    57 Yantai Yuhangding Hospital Yantai Shandong China 264000
    58 Sinopharm Coal Mine General Hospital Datong Shanxi China 037000
    59 Linfen Central Hospital Linfen Shanxi China 041000
    60 Linfen People's Hospital Linfen Shanxi China 041000
    61 Shanxi Cardiovascular Disease Hospital Taiyuan Shanxi China 030000
    62 Dazhu County People's Hospital Dazhu Sichuan China 635199
    63 Mianyang Central Hospital Mianyang Sichuan China 621000

    Sponsors and Collaborators

    • Beijing Tiantan Hospital
    • Jiangsu FENG HUA Biotech Pharmaceutical Co., Ltd
    • The Place Pharmaceutical(Jiangsu) Co., Ltd

    Investigators

    • Study Director: Shuya Li, IRB of Beijing Tiantan Hospital,Capital Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Yongjun Wang, President of Beijing Tiantan Hospital, Capital Medical University, Director of Neurology Center, Beijing Tiantan Hospital
    ClinicalTrials.gov Identifier:
    NCT05745259
    Other Study ID Numbers:
    • PR-FHSW-2022001F
    First Posted:
    Feb 27, 2023
    Last Update Posted:
    Feb 27, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yongjun Wang, President of Beijing Tiantan Hospital, Capital Medical University, Director of Neurology Center, Beijing Tiantan Hospital
    TNK-tPA, rt-PA, Acute stroke, phase Ⅲ trial
    Additional relevant MeSH terms:
    Stroke
    Ischemic Stroke
    Cerebral Infarction
    Ischemia
    Tissue Plasminogen Activator
    Tenecteplase

    Study Results

    No Results Posted as of Feb 27, 2023