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

Last updated: February 16, 2023
Sponsor: Beijing Tiantan Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Thrombosis

Stroke

Occlusions

Treatment

N/A

Clinical Study ID

NCT05745259
PR-FHSW-2022001F
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 finallyappear 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

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 lesionslarger than one third of the territory of the middle cerebral artery or with a volumelarger 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 abaseline 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 hourspreceding the onset of stroke with abnormal coagulation parameters or platelet count;
  • BP couldn't be controlled with aggressive treatment. Uncontrolled hypertension wasdefined 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 asgastrointestinal, urinary tract or retinal bleeding)
  • Tumors with an increased risk of bleeding.
  • Prolonged or traumatic cardiopulmonary resuscitation (>2 min), delivery within thelast 10 days or recent puncture of non-compression vessels such as subclavian vein orjugular vein
  • Acute pancreatitis or severe liver disease, including liver failure, cirrhosis, portalhypertension, 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 lessthan 3 months;
  • Unable to complete neurological assessment and follow-up visits because of dementia ormental 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 bythe investigators.

Study Design

Total Participants: 1630
Study Start date:
October 26, 2022
Estimated Completion Date:
March 29, 2024

Study 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.

Connect with a study center

  • Xuancheng People's Hospital

    Xuancheng, Anhui 242000
    China

    Site Not Available

  • Beijing Tiantan Hospital, Capital Medical University Beijing

    Beijing, Beijing 100000
    China

    Site Not Available

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing 100053
    China

    Site Not Available

  • Three Gorges Hospital Affiliated to Chongqing University

    Chongqing, Chongqing 404100
    China

    Terminated

  • Quanzhou First Hospital

    Quanzhou, Fujian 362000
    China

    Site Not Available

  • Lanzhou University First Hospital

    Lanzhou, Gansu 730000
    China

    Site Not Available

  • The Third People's Hospital of Huizhou

    Huizhou, Guangdong 516000
    China

    Site Not Available

  • Yuebei People's Hospital

    Shaoguan, Guangdong 512000
    China

    Site Not Available

  • The First People's Hospital of Yulin

    Yulin, Guangxi 541000
    China

    Site Not Available

  • Handan Central Hospital

    Handan, Hebei 056000
    China

    Site Not Available

  • Hengshui people's Hospital (Harrison International Peace Hospital)

    Hengshui, Hebei 053000
    China

    Active - Recruiting

  • Tangshan Workers' Hospital

    Tangshan, Hebei 063000
    China

    Site Not Available

  • Daqing Oilfield General Hospital

    Daqing, Heilongjiang 163000
    China

    Site Not Available

  • Daqing People's Hospital

    Daqing, Heilongjiang 163000
    China

    Site Not Available

  • Anyang People's Hospital

    Anyang, Henan 455100
    China

    Site Not Available

  • Jiaozuo People's Hospital

    Jiaozuo, Henan 454000
    China

    Site Not Available

  • Nanyang South Stone Hospital

    Nanyang, Henan 473000
    China

    Site Not Available

  • Pingmei Shenma medical group general hospital

    Pingdingshan, Henan 467000
    China

    Site Not Available

  • Xinxiang Central Hospital

    Xinxiang, Henan 453000
    China

    Site Not Available

  • Zhoukou Downtown Hospital

    Zhoukou, Henan 466000
    China

    Site Not Available

  • The First People's Hospital of Jingzhou

    Jingzhou,, Hubei 434000
    China

    Site Not Available

  • Baogang Hospital of Inner Monglia

    Baotou, Inner Monglia 014010
    China

    Site Not Available

  • Baotou Central Hospital

    Baotou, Inner Mongolia 014010
    China

    Site Not Available

  • Keshenketengqi Mongolian Medicine Hospital

    Chifeng, Inner Mongolia 025300
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Suzhou Medical University

    Suzhou, Jiangsu 215000
    China

    Site Not Available

  • Taizhou People's Hospital

    Taizhou, Jiangsu 225300
    China

    Site Not Available

  • The Affiliated Hospital of Xuhzou Meidcal University

    Xuzhou, Jiangsu 221006
    China

    Site Not Available

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu 221000
    China

    Site Not Available

  • Xuzhou Mining Group General Hospital

    Xuzhou, Jiangsu 221000
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

  • Jilin Guowen Hospital

    Siping, Jilin 136000
    China

    Site Not Available

  • Siping Central People's Hospital

    Siping, Jilin 136000
    China

    Site Not Available

  • Meihekou Central Hospital

    Tonghua, Jilin 135000
    China

    Site Not Available

  • Tonghua Central Hospital

    Tonghua, Jilin 134100
    China

    Site Not Available

  • Beipiao Central Hospital

    Beipiao, Liaoning 122000
    China

    Active - Recruiting

  • Dalian Central Hospital

    Dalian, Liaoning 116000
    China

    Site Not Available

  • Fushun Mining Bureau General Hospital

    Fushun, Liaoning 113000
    China

    Site Not Available

  • Liaoning Health Industry Group Fuxin Mine General Hospital

    Fuxin, Liaoning 123100
    China

    Site Not Available

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning 121000
    China

    Site Not Available

  • Affiliated Central Hospital of Shenyang Medical College

    ShenYang, Liaoning 111000
    China

    Site Not Available

  • The First Affiliated Hospital of China Medical University

    ShenYang, Liaoning 111000
    China

    Site Not Available

  • Air Force Hospital of Northern War Zone,PLA

    Shenyang, Liaoning 111000
    China

    Site Not Available

  • General Hospital of Northern War Zone,PLA

    Shenyang, Liaoning 111000
    China

    Site Not Available

  • The First People's Hospital of Shenyang

    Shenyang, Liaoning 111000
    China

    Site Not Available

  • General Hospital of Ningxia Medical University Cardio-cerebral Vascular Disease Hospital

    Yinchuan, Ningxia 750000
    China

    Site Not Available

  • The First People's Hospital of Yinchuan

    Yinchuan, Ningxia 750000
    China

    Site Not Available

  • Dezhou Hospital of Shandong University Qilu Hospital (Dezhou People's Hospital)

    Dezhou, Shandong 253000
    China

    Site Not Available

  • Jinan People's Hospital

    Jinan, Shandong 250000
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250012
    China

    Site Not Available

  • Liaocheng People's Hospital

    Liaocheng, Shandong 252006
    China

    Site Not Available

  • Linyi Hospital of Traditional Chinese Medicine

    Linyi, Shandong 273300
    China

    Site Not Available

  • Linyi People's Hospital

    Linyi, Shandong 273300
    China

    Site Not Available

  • The First People's Hospital of Tancheng County

    Linyi, Shandong 2761000
    China

    Active - Recruiting

  • Taian Central Hospital (Tai 'an Central Hospital of Qingdao University, Tai 'an Medical and Nursing Center)

    Taian, Shandong 271000
    China

    Site Not Available

  • Tengzhou Central Hospital

    Tengzhou, Shandong 277500
    China

    Site Not Available

  • Weifang Hospital of Traditional Chinese Medicine

    Weifang, Shandong 261000
    China

    Site Not Available

  • Yantai Yuhangding Hospital

    Yantai, Shandong 264000
    China

    Site Not Available

  • Sinopharm Coal Mine General Hospital

    Datong, Shanxi 037000
    China

    Site Not Available

  • Linfen Central Hospital

    Linfen, Shanxi 041000
    China

    Active - Recruiting

  • Linfen People's Hospital

    Linfen, Shanxi 041000
    China

    Site Not Available

  • Shanxi Cardiovascular Disease Hospital

    Taiyuan, Shanxi 030000
    China

    Site Not Available

  • Dazhu County People's Hospital

    Dazhu, Sichuan 635199
    China

    Site Not Available

  • Mianyang Central Hospital

    Mianyang, Sichuan 621000
    China

    Site Not Available

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