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

Primary Purpose

Acute Ischemic Stroke

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Alteplase
Tenecteplase
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring TNK-tPA, rt-PA, Acute stroke, phase Ⅲ trial

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xuancheng People's Hospital
  • Beijing Tiantan Hospital, Capital Medical University Beijing
  • Xuanwu Hospital Capital Medical University
  • Three Gorges Hospital Affiliated to Chongqing University
  • Quanzhou First Hospital
  • Lanzhou University First Hospital
  • The Third People's Hospital of Huizhou
  • Yuebei People's Hospital
  • The First People's Hospital of Yulin
  • Handan Central Hospital
  • Hengshui people's Hospital (Harrison International Peace Hospital)Recruiting
  • Tangshan Workers' Hospital
  • Daqing Oilfield General Hospital
  • Daqing People's Hospital
  • Anyang People's Hospital
  • Jiaozuo People's Hospital
  • Nanyang South Stone Hospital
  • Pingmei Shenma medical group general hospital
  • Xinxiang Central Hospital
  • Zhoukou Downtown Hospital
  • The First People's Hospital of Jingzhou
  • Baogang Hospital of Inner Monglia
  • Baotou Central Hospital
  • Keshenketengqi Mongolian Medicine HospitalRecruiting
  • The Second Affiliated Hospital of Suzhou Medical University
  • Taizhou People's Hospital
  • Xuzhou Central Hospital
  • Xuzhou Mining Group General Hospital
  • The Affiliated Hospital of Xuhzou Meidcal University
  • The First Hospital of Jilin University
  • Jilin Guowen Hospital
  • Siping Central People's Hospital
  • Tonghua Central Hospital
  • Meihekou Central Hospital
  • Beipiao Central HospitalRecruiting
  • Dalian Central Hospital
  • Fushun Mining Bureau General Hospital
  • Liaoning Health Industry Group Fuxin Mine General Hospital
  • The First Affiliated Hospital of Jinzhou Medical University
  • Affiliated Central Hospital of Shenyang Medical College
  • Air Force Hospital of Northern War Zone,PLA
  • General Hospital of Northern War Zone,PLA
  • The First Affiliated Hospital of China Medical University
  • The First People's Hospital of Shenyang
  • General Hospital of Ningxia Medical University Cardio-cerebral Vascular Disease Hospital
  • The First People's Hospital of Yinchuan
  • Dezhou Hospital of Shandong University Qilu Hospital (Dezhou People's Hospital)
  • Jinan People's Hospital
  • Qilu Hospital of Shandong University
  • Liaocheng People's Hospital
  • Linyi Hospital of Traditional Chinese Medicine
  • Linyi People's Hospital
  • The First People's Hospital of Tancheng CountyRecruiting
  • Taian Central Hospital (Tai 'an Central Hospital of Qingdao University, Tai 'an Medical and Nursing Center)
  • Tengzhou Central Hospital
  • Weifang Hospital of Traditional Chinese Medicine
  • Yantai Yuhangding Hospital
  • Sinopharm Coal Mine General Hospital
  • Linfen Central HospitalRecruiting
  • Linfen People's Hospital
  • Shanxi Cardiovascular Disease Hospital
  • Dazhu County People's Hospital
  • Mianyang Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Alteplase

Tenecteplase

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

National Institutes of Health Stroke Scale (NIHSS)
NIHSS score at 24±2 hours.
National Institutes of Health Stroke Scale (NIHSS)
Proportion of subjects with ≥ 4 point reduction in NIHSS or reaching 0-1 at 7 ± 2 days or before discharge (whichever occurs first)
Modified Rankin Scale(mRS)
Proportion of subjects with mRS scores of (0-2) at 90±7 days.
Modified Rankin Scale(mRS)
mRS scores at 90±7 days.
The new vascular events
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)
EQ-5D
EQ-5D scores at 90±7 days.

Full Information

First Posted
February 16, 2023
Last Updated
February 16, 2023
Sponsor
Beijing Tiantan Hospital
Collaborators
Jiangsu FENG HUA Biotech Pharmaceutical Co., Ltd, The Place Pharmaceutical(Jiangsu) Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05745259
Brief Title
Thrombolysis Treated With TNK-tPA in Acute Ischemic Stroke Patients (3T Stroke-Ⅲ)
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2022 (Actual)
Primary Completion Date
November 4, 2023 (Anticipated)
Study Completion Date
March 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
Collaborators
Jiangsu FENG HUA Biotech Pharmaceutical Co., Ltd, The Place Pharmaceutical(Jiangsu) Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
TNK-tPA, rt-PA, Acute stroke, phase Ⅲ trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1630 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alteplase
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Tenecteplase
Arm Type
Experimental
Arm Description
Patients will receive intravenous Tenecteplase, 0.25mg/kg, maximum 25mg, administered as a bolus over 5~10 seconds
Intervention Type
Drug
Intervention Name(s)
Alteplase
Other Intervention Name(s)
rt-PA
Intervention Description
Alteplase 0.9mg/kg are being used.
Intervention Type
Drug
Intervention Name(s)
Tenecteplase
Other Intervention Name(s)
TNK-tPA
Intervention Description
Tenecteplase 0.25mg/kg are being used.
Primary Outcome Measure Information:
Title
Modified Rankin Scale(mRS)
Description
Proportion of subjects with mRS scores of (0-1) at 90±7 days.
Time Frame
90±7 days
Secondary Outcome Measure Information:
Title
National Institutes of Health Stroke Scale (NIHSS)
Description
NIHSS score at 24±2 hours.
Time Frame
24±2 hours
Title
National Institutes of Health Stroke Scale (NIHSS)
Description
Proportion of subjects with ≥ 4 point reduction in NIHSS or reaching 0-1 at 7 ± 2 days or before discharge (whichever occurs first)
Time Frame
7±2days or discharge
Title
Modified Rankin Scale(mRS)
Description
Proportion of subjects with mRS scores of (0-2) at 90±7 days.
Time Frame
90±7 days
Title
Modified Rankin Scale(mRS)
Description
mRS scores at 90±7 days.
Time Frame
90±7 days
Title
The new vascular events
Description
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)
Time Frame
90±7 days
Title
EQ-5D
Description
EQ-5D scores at 90±7 days.
Time Frame
90±7 days
Other Pre-specified Outcome Measures:
Title
Symptomatic intracranial hemorrhage(sICH)
Description
Incidence of symptomatic intracranial hemorrhage (sICH) within 24~36 hours.( According to ECASS Ⅲ and SITS-MOST)
Time Frame
24~36 hours post treatment
Title
Parenchymal hematoma intracranial hemorrhage (type PH2, SITS-MOST)
Description
Incidence of intracranial hemorrhage (type PH2, SITS-MOST) within 24~36 hours.
Time Frame
24~36 hours post treatment
Title
Any intracranial hemorrhage
Description
Incidence of any intracranial hemorrhage within 24~36 hours.
Time Frame
24~36 hours post treatment
Title
Systematic bleeding
Description
Incidence of Systematic bleeding within 36 hours. (defined by GUSTO)
Time Frame
36 hours
Title
Deaths
Description
Vascular mortality at 90±7 days (mainly due to stroke, myocardial infarction or pulmonary embolism)
Time Frame
90±7 days
Title
Deaths
Description
Mortality due to any cause at 90±7days.
Time Frame
90±7 days
Title
SAEs
Description
Incidence of severe adverse events(SAEs) at 90±7 days.
Time Frame
90±7 days
Title
AEs
Description
Incidence of adverse events(AEs) at 90±7 days.
Time Frame
90±7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongjun Wang
Phone
13911172565
Email
yongjunwang111@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shuya Li
Phone
13601367028
Email
shuyali85@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuya Li
Organizational Affiliation
IRB of Beijing Tiantan Hospital,Capital Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Xuancheng People's Hospital
City
Xuancheng
State/Province
Anhui
ZIP/Postal Code
242000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yinong Chen
Phone
15956360890
Email
2chenyinon@163.com
First Name & Middle Initial & Last Name & Degree
Yinong Chen
Facility Name
Beijing Tiantan Hospital, Capital Medical University Beijing
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongjun Wang
Phone
13911172565
Email
yongjunwang111@aliyun.com
First Name & Middle Initial & Last Name & Degree
Yongjun U Wang
Facility Name
Xuanwu Hospital Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingfeng Ma
Phone
18510929092
Email
m.qingfeng@163.com
First Name & Middle Initial & Last Name & Degree
Qingfeng Ma
Facility Name
Three Gorges Hospital Affiliated to Chongqing University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
404100
Country
China
Individual Site Status
Terminated
Facility Name
Quanzhou First Hospital
City
Quanzhou
State/Province
Fujian
ZIP/Postal Code
362000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhuquan Hong
Phone
15345951812
Email
971696252@qq.com
First Name & Middle Initial & Last Name & Degree
Zhuquan Hong
Facility Name
Lanzhou University First Hospital
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Chen
Phone
13993193823
Email
cj0158@163.com
First Name & Middle Initial & Last Name & Degree
Jun Chen
Facility Name
The Third People's Hospital of Huizhou
City
Huizhou
State/Province
Guangdong
ZIP/Postal Code
516000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongyuan Piao
Phone
18829975340
Email
piaozhongyuan@126.com
First Name & Middle Initial & Last Name & Degree
Zhongyuan Piao
Facility Name
Yuebei People's Hospital
City
Shaoguan
State/Province
Guangdong
ZIP/Postal Code
512000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junbin Chen
Phone
13500205898
Email
CJBCL0397@163.com
First Name & Middle Initial & Last Name & Degree
Junbin Chen
Facility Name
The First People's Hospital of Yulin
City
Yulin
State/Province
Guangxi
ZIP/Postal Code
541000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weilin Liang
Phone
13607758784
Email
Lwl2674238@163.com
First Name & Middle Initial & Last Name & Degree
Weilin Liang
Facility Name
Handan Central Hospital
City
Handan
State/Province
Hebei
ZIP/Postal Code
056000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongbo Zhang
Phone
13831000939
Email
36471980@qq.com
First Name & Middle Initial & Last Name & Degree
Zhongbo Zhang
Facility Name
Hengshui people's Hospital (Harrison International Peace Hospital)
City
Hengshui
State/Province
Hebei
ZIP/Postal Code
053000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Wei
Phone
18003188568
Email
hayuanwy@163.com
First Name & Middle Initial & Last Name & Degree
Yan Wei
Facility Name
Tangshan Workers' Hospital
City
Tangshan
State/Province
Hebei
ZIP/Postal Code
063000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Liu
Phone
15903159765
Email
angel.jsea@163.com
First Name & Middle Initial & Last Name & Degree
Jing Liu
Facility Name
Daqing Oilfield General Hospital
City
Daqing
State/Province
Heilongjiang
ZIP/Postal Code
163000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Deng
Phone
18245977799
Email
syb030407@qq.com
First Name & Middle Initial & Last Name & Degree
Dan Deng
Facility Name
Daqing People's Hospital
City
Daqing
State/Province
Heilongjiang
ZIP/Postal Code
163000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dexin Luo
Phone
13359608879
Email
dr.ldx@163.com
First Name & Middle Initial & Last Name & Degree
Dexin Luo
Facility Name
Anyang People's Hospital
City
Anyang
State/Province
Henan
ZIP/Postal Code
455100
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun Zhang
Phone
16637232838
Email
13937210880@163.com
First Name & Middle Initial & Last Name & Degree
Yun Zhang
Facility Name
Jiaozuo People's Hospital
City
Jiaozuo
State/Province
Henan
ZIP/Postal Code
454000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haidong Lv
Phone
13598509338
Email
hnlhd666@163.com
First Name & Middle Initial & Last Name & Degree
Haidong Lv
Facility Name
Nanyang South Stone Hospital
City
Nanyang
State/Province
Henan
ZIP/Postal Code
473000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Liu
Phone
13525156232
Email
813577982@qq.com
First Name & Middle Initial & Last Name & Degree
Bin Liu
Facility Name
Pingmei Shenma medical group general hospital
City
Pingdingshan
State/Province
Henan
ZIP/Postal Code
467000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongwei Zhang
Phone
13949457905
Email
jsjyan1zhanghongwei@126.com
First Name & Middle Initial & Last Name & Degree
Hongwei Zhang
Facility Name
Xinxiang Central Hospital
City
Xinxiang
State/Province
Henan
ZIP/Postal Code
453000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Zhang
Phone
15637359131
Email
hyszhangmin@sina.com
First Name & Middle Initial & Last Name & Degree
Min Zhang
Facility Name
Zhoukou Downtown Hospital
City
Zhoukou
State/Province
Henan
ZIP/Postal Code
466000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Xia
Phone
18639493636
Email
391114308@qq.com
First Name & Middle Initial & Last Name & Degree
Lei Xia
Facility Name
The First People's Hospital of Jingzhou
City
Jingzhou,
State/Province
Hubei
ZIP/Postal Code
434000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Yang
Phone
18163139070
Email
yangtao9819@163.com
First Name & Middle Initial & Last Name & Degree
Tao Yang
Facility Name
Baogang Hospital of Inner Monglia
City
Baotou
State/Province
Inner Monglia
ZIP/Postal Code
014010
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suping Wang
Phone
13948522612
Email
13948522612@163.com
First Name & Middle Initial & Last Name & Degree
Suping Wang
Facility Name
Baotou Central Hospital
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014010
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baojun Wang
Phone
13384858794
Email
jbwwbj@126.com
First Name & Middle Initial & Last Name & Degree
Baojun Wang
Facility Name
Keshenketengqi Mongolian Medicine Hospital
City
Chifeng
State/Province
Inner Mongolia
ZIP/Postal Code
025300
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guozhi Lu
Phone
13722169555
Email
1073281716@qq.com
First Name & Middle Initial & Last Name & Degree
Guozhi Lu
Facility Name
The Second Affiliated Hospital of Suzhou Medical University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunfeng Liu
Phone
13606210609
Email
liucf20@163.com
First Name & Middle Initial & Last Name & Degree
Chunfeng Liu
Facility Name
Taizhou People's Hospital
City
Taizhou
State/Province
Jiangsu
ZIP/Postal Code
225300
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Liu
Phone
13952618801
Email
13952618801@163.com
First Name & Middle Initial & Last Name & Degree
Ying Liu
Facility Name
Xuzhou Central Hospital
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guofang Chen
Phone
18952172823
Email
cgfxdd@126.com
First Name & Middle Initial & Last Name & Degree
Guofang Chen
Facility Name
Xuzhou Mining Group General Hospital
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiu 'e Wei
Phone
15005206672
Email
wxeqq@163.com
First Name & Middle Initial & Last Name & Degree
Xiu 'e Wei
Facility Name
The Affiliated Hospital of Xuhzou Meidcal University
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221006
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanbo Cheng
Phone
18052268195
Email
46140705@qq.com
First Name & Middle Initial & Last Name & Degree
Yanbo Cheng
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Yang
Phone
13756661217
Email
doctoryangyi@163.com
First Name & Middle Initial & Last Name & Degree
Yi Yang
Facility Name
Jilin Guowen Hospital
City
Siping
State/Province
Jilin
ZIP/Postal Code
136000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinming Ding
Phone
13630703939
Email
274486000@163.com
First Name & Middle Initial & Last Name & Degree
Jinming Ding
Facility Name
Siping Central People's Hospital
City
Siping
State/Province
Jilin
ZIP/Postal Code
136000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junfeng Zhao
Phone
13843443119
Email
jlspzjf2727@163.com
First Name & Middle Initial & Last Name & Degree
Junfeng Zhao
Facility Name
Tonghua Central Hospital
City
Tonghua
State/Province
Jilin
ZIP/Postal Code
134100
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lianhuan Zhang
Phone
15944509098
Email
15944509098@163.com
First Name & Middle Initial & Last Name & Degree
Lianhuan Zhang
Facility Name
Meihekou Central Hospital
City
Tonghua
State/Province
Jilin
ZIP/Postal Code
135000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Yu
Phone
13844564195
Email
2823974848@qq.com
First Name & Middle Initial & Last Name & Degree
Shugen Han
First Name & Middle Initial & Last Name & Degree
Hong Yu
Facility Name
Beipiao Central Hospital
City
Beipiao
State/Province
Liaoning
ZIP/Postal Code
122000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yutong Ma
Phone
18642143339
Email
myt3339@163.com
First Name & Middle Initial & Last Name & Degree
Yutong Ma
Facility Name
Dalian Central Hospital
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lizhen Zhong
Phone
19969310278
Email
zlz0117@163.com
First Name & Middle Initial & Last Name & Degree
Lizhen Zhong
Facility Name
Fushun Mining Bureau General Hospital
City
Fushun
State/Province
Liaoning
ZIP/Postal Code
113000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Zhang
Phone
15694236301
Email
zhanghong429@163.com
First Name & Middle Initial & Last Name & Degree
Hong Zhang
Facility Name
Liaoning Health Industry Group Fuxin Mine General Hospital
City
Fuxin
State/Province
Liaoning
ZIP/Postal Code
123100
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingjie Duan
Phone
13470363261
Email
451142359@qq.com
First Name & Middle Initial & Last Name & Degree
Yingjie Duan
Facility Name
The First Affiliated Hospital of Jinzhou Medical University
City
Jinzhou
State/Province
Liaoning
ZIP/Postal Code
121000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuewen Liu
Phone
13940644988
Email
sjnklxw@163.com
First Name & Middle Initial & Last Name & Degree
Xuewen Liu
Facility Name
Affiliated Central Hospital of Shenyang Medical College
City
ShenYang
State/Province
Liaoning
ZIP/Postal Code
111000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Runhui Li
Phone
18002477116
Email
lirh710717@163.com
First Name & Middle Initial & Last Name & Degree
Runhui Li
Facility Name
Air Force Hospital of Northern War Zone,PLA
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
111000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Wang
Phone
13322445060
Email
hbf44132@163.com
First Name & Middle Initial & Last Name & Degree
Jing Wang
Facility Name
General Hospital of Northern War Zone,PLA
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
111000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huisheng Chen
Phone
13352452086
Email
chszh@aliyun.com
First Name & Middle Initial & Last Name & Degree
Huisheng Chen
Facility Name
The First Affiliated Hospital of China Medical University
City
ShenYang
State/Province
Liaoning
ZIP/Postal Code
111000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuansheng Zhao
Phone
13940369251
Email
chszh@aliyun.com
First Name & Middle Initial & Last Name & Degree
Chuansheng Zhao
Facility Name
The First People's Hospital of Shenyang
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
111000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Sui
Phone
13998352587
Email
tjyiia@hotmail.com
First Name & Middle Initial & Last Name & Degree
Yi Sui
Facility Name
General Hospital of Ningxia Medical University Cardio-cerebral Vascular Disease Hospital
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuewen Fan
Phone
13709575965
Email
nxfxw@163.com
First Name & Middle Initial & Last Name & Degree
Xuewen Fan
Facility Name
The First People's Hospital of Yinchuan
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangdong Bai
Phone
13909595823
Email
xdwhite@163.com
First Name & Middle Initial & Last Name & Degree
Xiangdong Bai
Facility Name
Dezhou Hospital of Shandong University Qilu Hospital (Dezhou People's Hospital)
City
Dezhou
State/Province
Shandong
ZIP/Postal Code
253000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lixin Qu
Phone
15589185707
Email
Qulx12060057@163.com
First Name & Middle Initial & Last Name & Degree
Qu Lixin
Facility Name
Jinan People's Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Menghai Wu
Phone
18963431366
Email
24967496@qq.com
First Name & Middle Initial & Last Name & Degree
Menghai Wu
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Wu
Phone
18560082121
Email
drwuwei@126.com
First Name & Middle Initial & Last Name & Degree
Wei Wu
Facility Name
Liaocheng People's Hospital
City
Liaocheng
State/Province
Shandong
ZIP/Postal Code
252006
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cunju Guo
Phone
13346256168
Email
cunjuguo@163.com
First Name & Middle Initial & Last Name & Degree
Cunju Guo
Facility Name
Linyi Hospital of Traditional Chinese Medicine
City
Linyi
State/Province
Shandong
ZIP/Postal Code
273300
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziran Wang
Phone
13954993801
Email
wzr0806@163.com
First Name & Middle Initial & Last Name & Degree
Ziran Wang
Facility Name
Linyi People's Hospital
City
Linyi
State/Province
Shandong
ZIP/Postal Code
273300
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziran Wang
Phone
13954993801
Email
wzr0806@163.com
First Name & Middle Initial & Last Name & Degree
Ziran Wang
Facility Name
The First People's Hospital of Tancheng County
City
Linyi
State/Province
Shandong
ZIP/Postal Code
2761000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Du
Phone
13969913520
Email
529541360@qq.com
First Name & Middle Initial & Last Name & Degree
Wei Du
Facility Name
Taian Central Hospital (Tai 'an Central Hospital of Qingdao University, Tai 'an Medical and Nursing Center)
City
Taian
State/Province
Shandong
ZIP/Postal Code
271000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunlin Liu
Phone
13375388398
Email
bb0538@163.com
First Name & Middle Initial & Last Name & Degree
Yunlin Liu
Facility Name
Tengzhou Central Hospital
City
Tengzhou
State/Province
Shandong
ZIP/Postal Code
277500
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deyang Li
Phone
13561190369
Email
lideyang0632@163.com
First Name & Middle Initial & Last Name & Degree
Deyang Li
Facility Name
Weifang Hospital of Traditional Chinese Medicine
City
Weifang
State/Province
Shandong
ZIP/Postal Code
261000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Liu
Phone
13791699198
Email
liutao.wf@163.com
First Name & Middle Initial & Last Name & Degree
Tao Liu
Facility Name
Yantai Yuhangding Hospital
City
Yantai
State/Province
Shandong
ZIP/Postal Code
264000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhigang Liang
Phone
13723987720
Email
zgliang@hotmail.com
First Name & Middle Initial & Last Name & Degree
Zhigang Liang
Facility Name
Sinopharm Coal Mine General Hospital
City
Datong
State/Province
Shanxi
ZIP/Postal Code
037000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junhai Wang
Phone
13753265757
Email
wjh1964@sohu.com
First Name & Middle Initial & Last Name & Degree
Junhai Wang
Facility Name
Linfen Central Hospital
City
Linfen
State/Province
Shanxi
ZIP/Postal Code
041000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongguo Dai
Phone
15935767592
Email
daihongguo3199@163.com
First Name & Middle Initial & Last Name & Degree
Hongguo Dai
Facility Name
Linfen People's Hospital
City
Linfen
State/Province
Shanxi
ZIP/Postal Code
041000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junfang Hao
Phone
13835360973
Email
haojunfan2012@163.com
First Name & Middle Initial & Last Name & Degree
Junfang Hao
Facility Name
Shanxi Cardiovascular Disease Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weirong Li
Phone
18735133366
Email
weironglee@163.com
First Name & Middle Initial & Last Name & Degree
Weirong Li
Facility Name
Dazhu County People's Hospital
City
Dazhu
State/Province
Sichuan
ZIP/Postal Code
635199
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaohui Li
Phone
13982833951
Email
187188178@qq.com
First Name & Middle Initial & Last Name & Degree
Zhaohui Li
Facility Name
Mianyang Central Hospital
City
Mianyang
State/Province
Sichuan
ZIP/Postal Code
621000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yufeng Tang
Phone
13981184028
Email
dryufeng@126.com
First Name & Middle Initial & Last Name & Degree
Yufeng Tang

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Standards and procedures for rapid reporting of safety data during drug clinical trials
Results Reference
background

Learn more about this trial

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

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