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

February 16, 2023 updated by: Yongjun Wang, Beijing Tiantan Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1630

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Xuancheng, Anhui, China, 242000
        • Not yet recruiting
        • Xuancheng People's Hospital
        • Contact:
        • Principal Investigator:
          • Yinong Chen
    • Beijing
      • Beijing, Beijing, China, 100053
        • Not yet recruiting
        • Xuanwu Hospital Capital Medical University
        • Principal Investigator:
          • Qingfeng Ma
        • Contact:
      • Beijing, Beijing, China, 100000
        • Not yet recruiting
        • Beijing Tiantan Hospital, Capital Medical University Beijing
        • Principal Investigator:
          • Yongjun U Wang
    • Chongqing
      • Chongqing, Chongqing, China, 404100
        • Terminated
        • Three Gorges Hospital Affiliated to Chongqing University
    • Fujian
      • Quanzhou, Fujian, China, 362000
        • Not yet recruiting
        • Quanzhou First Hospital
        • Contact:
        • Principal Investigator:
          • Zhuquan Hong
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Not yet recruiting
        • Lanzhou University First Hospital
        • Contact:
        • Principal Investigator:
          • Jun Chen
    • Guangdong
      • Huizhou, Guangdong, China, 516000
        • Not yet recruiting
        • The Third People's Hospital of Huizhou
        • Contact:
        • Principal Investigator:
          • Zhongyuan Piao
      • Shaoguan, Guangdong, China, 512000
        • Not yet recruiting
        • Yuebei People's Hospital
        • Contact:
        • Principal Investigator:
          • Junbin Chen
    • Guangxi
      • Yulin, Guangxi, China, 541000
        • Not yet recruiting
        • The First People's Hospital of Yulin
        • Contact:
        • Principal Investigator:
          • Weilin Liang
    • Hebei
      • Handan, Hebei, China, 056000
        • Not yet recruiting
        • Handan Central Hospital
        • Contact:
        • Principal Investigator:
          • Zhongbo Zhang
      • Hengshui, Hebei, China, 053000
        • Recruiting
        • Hengshui People's Hospital (Harrison International Peace Hospital)
        • Contact:
        • Principal Investigator:
          • Yan Wei
      • Tangshan, Hebei, China, 063000
        • Not yet recruiting
        • Tangshan Workers' Hospital
        • Principal Investigator:
          • Jing Liu
        • Contact:
    • Heilongjiang
      • Daqing, Heilongjiang, China, 163000
        • Not yet recruiting
        • Daqing Oilfield General hospital
        • Contact:
        • Principal Investigator:
          • Dan Deng
      • Daqing, Heilongjiang, China, 163000
        • Not yet recruiting
        • Daqing People's Hospital
        • Contact:
        • Principal Investigator:
          • Dexin Luo
    • Henan
      • Anyang, Henan, China, 455100
        • Not yet recruiting
        • Anyang People's Hospital
        • Contact:
        • Principal Investigator:
          • Yun Zhang
      • Jiaozuo, Henan, China, 454000
        • Not yet recruiting
        • Jiaozuo People's Hospital
        • Contact:
        • Principal Investigator:
          • Haidong Lv
      • Nanyang, Henan, China, 473000
        • Not yet recruiting
        • Nanyang South Stone Hospital
        • Contact:
        • Principal Investigator:
          • Bin Liu
      • Pingdingshan, Henan, China, 467000
        • Not yet recruiting
        • Pingmei Shenma medical group general hospital
        • Contact:
        • Principal Investigator:
          • Hongwei Zhang
      • Xinxiang, Henan, China, 453000
        • Not yet recruiting
        • Xinxiang Central Hospital
        • Contact:
      • Zhoukou, Henan, China, 466000
        • Not yet recruiting
        • Zhoukou Downtown Hospital
        • Contact:
        • Principal Investigator:
          • Lei Xia
    • Hubei
      • Jingzhou,, Hubei, China, 434000
        • Not yet recruiting
        • The First People's Hospital of Jingzhou
        • Contact:
        • Principal Investigator:
          • Tao Yang
    • Inner Monglia
      • Baotou, Inner Monglia, China, 014010
        • Not yet recruiting
        • Baogang Hospital of Inner Monglia
        • Contact:
        • Principal Investigator:
          • Suping Wang
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014010
        • Not yet recruiting
        • Baotou Central Hospital
        • Contact:
        • Principal Investigator:
          • Baojun Wang
      • Chifeng, Inner Mongolia, China, 025300
        • Recruiting
        • Keshenketengqi Mongolian Medicine Hospital
        • Contact:
        • Principal Investigator:
          • Guozhi Lu
    • Jiangsu
      • Suzhou, Jiangsu, China, 215000
        • Not yet recruiting
        • The Second Affiliated Hospital of Suzhou Medical University
        • Contact:
      • Taizhou, Jiangsu, China, 225300
        • Not yet recruiting
        • Taizhou People's Hospital
        • Contact:
      • Xuzhou, Jiangsu, China, 221000
        • Not yet recruiting
        • Xuzhou Central Hospital
        • Contact:
      • Xuzhou, Jiangsu, China, 221000
        • Not yet recruiting
        • Xuzhou Mining Group General Hospital
        • Contact:
        • Principal Investigator:
          • Xiu 'e Wei
      • Xuzhou, Jiangsu, China, 221006
        • Not yet recruiting
        • The Affiliated Hospital of Xuhzou Meidcal University
        • Contact:
        • Principal Investigator:
          • Yanbo Cheng
    • Jilin
      • Changchun, Jilin, China, 130021
        • Not yet recruiting
        • The First Hospital of Jilin University
        • Contact:
        • Principal Investigator:
          • yi yang
      • Siping, Jilin, China, 136000
        • Not yet recruiting
        • Siping Central People's Hospital
        • Contact:
        • Principal Investigator:
          • Junfeng Zhao
      • Siping, Jilin, China, 136000
        • Not yet recruiting
        • Jilin Guowen Hospital
        • Contact:
        • Principal Investigator:
          • Jinming Ding
      • Tonghua, Jilin, China, 134100
        • Not yet recruiting
        • Tonghua Central Hospital
        • Contact:
        • Principal Investigator:
          • Lianhuan Zhang
      • Tonghua, Jilin, China, 135000
        • Not yet recruiting
        • Meihekou Central Hospital
        • Principal Investigator:
          • Hong Yu
        • Contact:
        • Principal Investigator:
          • Shugen Han
    • Liaoning
      • Beipiao, Liaoning, China, 122000
        • Recruiting
        • Beipiao Central Hospital
        • Contact:
        • Principal Investigator:
          • Yutong Ma
      • Dalian, Liaoning, China, 116000
        • Not yet recruiting
        • Dalian Central Hospital
        • Contact:
        • Principal Investigator:
          • Lizhen Zhong
      • Fushun, Liaoning, China, 113000
        • Not yet recruiting
        • Fushun Mining Bureau General Hospital
        • Contact:
        • Principal Investigator:
          • Hong Zhang
      • Fuxin, Liaoning, China, 123100
        • Not yet recruiting
        • Liaoning Health Industry Group Fuxin Mine General Hospital
        • Contact:
        • Principal Investigator:
          • Yingjie Duan
      • Jinzhou, Liaoning, China, 121000
        • Not yet recruiting
        • The First Affiliated Hospital of Jinzhou Medical University
        • Principal Investigator:
          • Xuewen Liu
        • Contact:
      • ShenYang, Liaoning, China, 111000
        • Not yet recruiting
        • Affiliated Central Hospital of Shenyang Medical College
        • Contact:
        • Principal Investigator:
          • Runhui Li
      • ShenYang, Liaoning, China, 111000
        • Not yet recruiting
        • The First Affiliated Hospital of China Medical University
        • Contact:
        • Principal Investigator:
          • Chuansheng Zhao
      • Shenyang, Liaoning, China, 111000
        • Not yet recruiting
        • Air Force Hospital of Northern War Zone,PLA
        • Principal Investigator:
          • Jing Wang
        • Contact:
      • Shenyang, Liaoning, China, 111000
        • Not yet recruiting
        • General Hospital of Northern War Zone,PLA
        • Contact:
        • Principal Investigator:
          • Huisheng Chen
      • Shenyang, Liaoning, China, 111000
        • Not yet recruiting
        • The first people's hospital of Shenyang
        • Contact:
        • Principal Investigator:
          • Yi Sui
    • Ningxia
      • Yinchuan, Ningxia, China, 750000
        • Not yet recruiting
        • General Hospital of Ningxia Medical University Cardio-cerebral Vascular Disease Hospital
        • Contact:
        • Principal Investigator:
          • Xuewen Fan
      • Yinchuan, Ningxia, China, 750000
        • Not yet recruiting
        • The First People's Hospital of Yinchuan
        • Contact:
        • Principal Investigator:
          • Xiangdong Bai
    • Shandong
      • Dezhou, Shandong, China, 253000
        • Not yet recruiting
        • Dezhou Hospital of Shandong University Qilu Hospital (Dezhou People's Hospital)
        • Contact:
        • Principal Investigator:
          • Qu Lixin
      • Jinan, Shandong, China, 250012
        • Not yet recruiting
        • Qilu Hospital Of Shandong University
        • Principal Investigator:
          • Wei Wu
        • Contact:
      • Jinan, Shandong, China, 250000
        • Not yet recruiting
        • Jinan People's Hospital
        • Contact:
        • Principal Investigator:
          • Menghai Wu
      • Liaocheng, Shandong, China, 252006
        • Not yet recruiting
        • LiaoCheng People's Hospital
        • Contact:
        • Principal Investigator:
          • Cunju Guo
      • Linyi, Shandong, China, 273300
        • Not yet recruiting
        • Linyi Hospital of Traditional Chinese Medicine
        • Contact:
        • Principal Investigator:
          • Ziran Wang
      • Linyi, Shandong, China, 273300
        • Not yet recruiting
        • Linyi People's Hospital
        • Contact:
        • Principal Investigator:
          • Ziran Wang
      • Linyi, Shandong, China, 2761000
        • Recruiting
        • The First People's Hospital of Tancheng County
        • Contact:
        • Principal Investigator:
          • Wei Du
      • Taian, Shandong, China, 271000
        • Not yet recruiting
        • Taian Central Hospital (Tai 'an Central Hospital of Qingdao University, Tai 'an Medical and Nursing Center)
        • Contact:
        • Principal Investigator:
          • Yunlin Liu
      • Tengzhou, Shandong, China, 277500
        • Not yet recruiting
        • Tengzhou Central Hospital
        • Contact:
        • Principal Investigator:
          • Deyang Li
      • Weifang, Shandong, China, 261000
        • Not yet recruiting
        • Weifang Hospital of Traditional Chinese Medicine
        • Contact:
        • Principal Investigator:
          • Tao Liu
      • Yantai, Shandong, China, 264000
        • Not yet recruiting
        • Yantai Yuhangding Hospital
        • Contact:
        • Principal Investigator:
          • Zhigang Liang
    • Shanxi
      • Datong, Shanxi, China, 037000
        • Not yet recruiting
        • Sinopharm Coal Mine General Hospital
        • Contact:
        • Principal Investigator:
          • Junhai Wang
      • Linfen, Shanxi, China, 041000
        • Recruiting
        • Linfen Central Hospital
        • Contact:
        • Principal Investigator:
          • Hongguo Dai
      • Linfen, Shanxi, China, 041000
        • Not yet recruiting
        • Linfen People's Hospital
        • Contact:
        • Principal Investigator:
          • Junfang Hao
      • Taiyuan, Shanxi, China, 030000
        • Not yet recruiting
        • Shanxi cardiovascular disease hospital
        • Contact:
        • Principal Investigator:
          • Weirong Li
    • Sichuan
      • Dazhu, Sichuan, China, 635199
        • Not yet recruiting
        • Dazhu County People's Hospital
        • Contact:
        • Principal Investigator:
          • Zhaohui Li
      • Mianyang, Sichuan, China, 621000
        • Not yet recruiting
        • Mianyang Central Hospital
        • Contact:
        • Principal Investigator:
          • Yufeng Tang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale(mRS)
Time Frame: 90±7 days
Proportion of subjects with mRS scores of (0-1) at 90±7 days.
90±7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The new vascular events
Time Frame: 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)
90±7 days
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: 24±2 hours
NIHSS score at 24±2 hours.
24±2 hours
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: 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)
7±2days or discharge
Modified Rankin Scale(mRS)
Time Frame: 90±7 days
Proportion of subjects with mRS scores of (0-2) at 90±7 days.
90±7 days
Modified Rankin Scale(mRS)
Time Frame: 90±7 days
mRS scores at 90±7 days.
90±7 days
EQ-5D
Time Frame: 90±7 days
EQ-5D scores at 90±7 days.
90±7 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deaths
Time Frame: 90±7 days
Vascular mortality at 90±7 days (mainly due to stroke, myocardial infarction or pulmonary embolism)
90±7 days
Deaths
Time Frame: 90±7 days
Mortality due to any cause at 90±7days.
90±7 days
Symptomatic intracranial hemorrhage(sICH)
Time Frame: 24~36 hours post treatment
Incidence of symptomatic intracranial hemorrhage (sICH) within 24~36 hours.( According to ECASS Ⅲ and SITS-MOST)
24~36 hours post treatment
Parenchymal hematoma intracranial hemorrhage (type PH2, SITS-MOST)
Time Frame: 24~36 hours post treatment
Incidence of intracranial hemorrhage (type PH2, SITS-MOST) within 24~36 hours.
24~36 hours post treatment
Any intracranial hemorrhage
Time Frame: 24~36 hours post treatment
Incidence of any intracranial hemorrhage within 24~36 hours.
24~36 hours post treatment
Systematic bleeding
Time Frame: 36 hours
Incidence of Systematic bleeding within 36 hours. (defined by GUSTO)
36 hours
SAEs
Time Frame: 90±7 days
Incidence of severe adverse events(SAEs) at 90±7 days.
90±7 days
AEs
Time Frame: 90±7 days
Incidence of adverse events(AEs) at 90±7 days.
90±7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2022

Primary Completion (Anticipated)

November 4, 2023

Study Completion (Anticipated)

March 29, 2024

Study Registration Dates

First Submitted

February 16, 2023

First Submitted That Met QC Criteria

February 16, 2023

First Posted (Estimate)

February 27, 2023

Study Record Updates

Last Update Posted (Estimate)

February 27, 2023

Last Update Submitted That Met QC Criteria

February 16, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR-FHSW-2022001F

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Ischemic Stroke

Clinical Trials on Alteplase

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe