Thrombolysis Treated With TNK-tPA in Acute Ischemic Stroke Patients （3T Stroke-Ⅲ）
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
1 other identifier
interventional
1,630
1 country
63
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2022
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 26, 2022
CompletedFirst Submitted
Initial submission to the registry
February 16, 2023
CompletedFirst Posted
Study publicly available on registry
February 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2024
CompletedFebruary 27, 2023
February 1, 2023
1 year
February 16, 2023
February 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Modified Rankin Scale(mRS)
Proportion of subjects with mRS scores of (0-1) at 90±7 days.
90±7 days
Secondary Outcomes (6)
National Institutes of Health Stroke Scale (NIHSS)
24±2 hours
National Institutes of Health Stroke Scale (NIHSS)
7±2days or discharge
Modified Rankin Scale(mRS)
90±7 days
Modified Rankin Scale(mRS)
90±7 days
The new vascular events
90±7 days
- +1 more secondary outcomes
Other Outcomes (8)
Symptomatic intracranial hemorrhage(sICH)
24~36 hours post treatment
Parenchymal hematoma intracranial hemorrhage (type PH2, SITS-MOST)
24~36 hours post treatment
Any intracranial hemorrhage
24~36 hours post treatment
- +5 more other outcomes
Study Arms (2)
Alteplase
ACTIVE COMPARATORPatients 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.
Tenecteplase
EXPERIMENTALPatients will receive intravenous Tenecteplase, 0.25mg/kg, maximum 25mg, administered as a bolus over 5\~10 seconds
Interventions
Eligibility Criteria
You may qualify if:
- ≤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.
You may not qualify if:
- 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;
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (63)
Xuancheng People's Hospital
Xuancheng, Anhui, 242000, China
Beijing Tiantan Hospital, Capital Medical University Beijing
Beijing, Beijing Municipality, 100000, China
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053, China
Three Gorges Hospital Affiliated to Chongqing University
Chongqing, Chongqing Municipality, 404100, China
Quanzhou First Hospital
Quanzhou, Fujian, 362000, China
Lanzhou University First Hospital
Lanzhou, Gansu, 730000, China
The Third People's Hospital of Huizhou
Huizhou, Guangdong, 516000, China
Yuebei People's Hospital
Shaoguan, Guangdong, 512000, China
The First People's Hospital of Yulin
Yulin, Guangxi, 541000, China
Handan Central Hospital
Handan, Hebei, 056000, China
Hengshui people's Hospital (Harrison International Peace Hospital)
Hengshui, Hebei, 053000, China
Tangshan Workers' Hospital
Tangshan, Hebei, 063000, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, 163000, China
Daqing People's Hospital
Daqing, Heilongjiang, 163000, China
Anyang People's Hospital
Anyang, Henan, 455100, China
Jiaozuo People's Hospital
Jiaozuo, Henan, 454000, China
Nanyang South Stone Hospital
Nanyang, Henan, 473000, China
Pingmei Shenma medical group general hospital
Pingdingshan, Henan, 467000, China
Xinxiang Central Hospital
Xinxiang, Henan, 453000, China
Zhoukou Downtown Hospital
Zhoukou, Henan, 466000, China
The First People's Hospital of Jingzhou
Jingzhou, Hubei, 434000, China
Baogang Hospital of Inner Monglia
Baotou, Inner Monglia, 014010, China
Baotou Central Hospital
Baotou, Inner Mongolia, 014010, China
Keshenketengqi Mongolian Medicine Hospital
Chifeng, Inner Mongolia, 025300, China
The Second Affiliated Hospital of Suzhou Medical University
Suzhou, Jiangsu, 215000, China
Taizhou People's Hospital
Taizhou, Jiangsu, 225300, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221000, China
Xuzhou Mining Group General Hospital
Xuzhou, Jiangsu, 221000, China
The Affiliated Hospital of Xuhzou Meidcal University
Xuzhou, Jiangsu, 221006, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Jilin Guowen Hospital
Siping, Jilin, 136000, China
Siping Central People's Hospital
Siping, Jilin, 136000, China
Tonghua Central Hospital
Tonghua, Jilin, 134100, China
Meihekou Central Hospital
Tonghua, Jilin, 135000, China
Beipiao Central Hospital
Beipiao, Liaoning, 122000, China
Dalian Central Hospital
Dalian, Liaoning, 116000, China
Fushun Mining Bureau General Hospital
Fushun, Liaoning, 113000, China
Liaoning Health Industry Group Fuxin Mine General Hospital
Fuxin, Liaoning, 123100, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121000, China
Affiliated Central Hospital of Shenyang Medical College
Shenyang, Liaoning, 111000, China
Air Force Hospital of Northern War Zone,PLA
Shenyang, Liaoning, 111000, China
General Hospital of Northern War Zone,PLA
Shenyang, Liaoning, 111000, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 111000, China
The First People's Hospital of Shenyang
Shenyang, Liaoning, 111000, China
General Hospital of Ningxia Medical University Cardio-cerebral Vascular Disease Hospital
Yinchuan, Ningxia, 750000, China
The First People's Hospital of Yinchuan
Yinchuan, Ningxia, 750000, China
Dezhou Hospital of Shandong University Qilu Hospital (Dezhou People's Hospital)
Dezhou, Shandong, 253000, China
Jinan People's Hospital
Jinan, Shandong, 250000, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Liaocheng People's Hospital
Liaocheng, Shandong, 252006, China
Linyi Hospital of Traditional Chinese Medicine
Linyi, Shandong, 273300, China
Linyi People's Hospital
Linyi, Shandong, 273300, China
The First People's Hospital of Tancheng County
Linyi, Shandong, 2761000, China
Taian Central Hospital (Tai 'an Central Hospital of Qingdao University, Tai 'an Medical and Nursing Center)
Taian, Shandong, 271000, China
Tengzhou Central Hospital
Tengzhou, Shandong, 277500, China
Weifang Hospital of Traditional Chinese Medicine
Weifang, Shandong, 261000, China
Yantai Yuhangding Hospital
Yantai, Shandong, 264000, China
Sinopharm Coal Mine General Hospital
Datong, Shanxi, 037000, China
Linfen Central Hospital
Linfen, Shanxi, 041000, China
Linfen People's Hospital
Linfen, Shanxi, 041000, China
Shanxi Cardiovascular Disease Hospital
Taiyuan, Shanxi, 030000, China
Dazhu County People's Hospital
Dazhu, Sichuan, 635199, China
Mianyang Central Hospital
Mianyang, Sichuan, 621000, China
Related Publications (19)
Guidelines Editing Group of Chinese Stroke Society, Guidelines for the Diagnosis and Treatment of High-risk Non-Disabling Ischemic Cerebrovascular Events, Chinese Journal of Stroke, June 2016, 11 (6), p481-491.
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PMID: 28780236BACKGROUNDCampbell BCV, Mitchell PJ, Churilov L, Yassi N, Kleinig TJ, Dowling RJ, Yan B, Bush SJ, Dewey HM, Thijs V, Scroop R, Simpson M, Brooks M, Asadi H, Wu TY, Shah DG, Wijeratne T, Ang T, Miteff F, Levi CR, Rodrigues E, Zhao H, Salvaris P, Garcia-Esperon C, Bailey P, Rice H, de Villiers L, Brown H, Redmond K, Leggett D, Fink JN, Collecutt W, Wong AA, Muller C, Coulthard A, Mitchell K, Clouston J, Mahady K, Field D, Ma H, Phan TG, Chong W, Chandra RV, Slater LA, Krause M, Harrington TJ, Faulder KC, Steinfort BS, Bladin CF, Sharma G, Desmond PM, Parsons MW, Donnan GA, Davis SM; EXTEND-IA TNK Investigators. Tenecteplase versus Alteplase before Thrombectomy for Ischemic Stroke. N Engl J Med. 2018 Apr 26;378(17):1573-1582. doi: 10.1056/NEJMoa1716405.
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PMID: 32467323BACKGROUNDStandards and procedures for rapid reporting of safety data during drug clinical trials
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shuya Li
IRB of Beijing Tiantan Hospital,Capital Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- President of Beijing Tiantan Hospital, Capital Medical University, Director of Neurology Center
Study Record Dates
First Submitted
February 16, 2023
First Posted
February 27, 2023
Study Start
October 26, 2022
Primary Completion
November 4, 2023
Study Completion
March 29, 2024
Last Updated
February 27, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share