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Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅱ (TRACEⅡ)

Primary Purpose

Acute Ischemic Stroke

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
rt-PA
rhTNK-tPA
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 rhTNK-tPA, acute, stroke, phaseⅢ, Acute Ischemic Stroke, rt-PA

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥18 years old, no gender limitation;
  • 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";
  • The clinical diagnosis was ischemic stroke (the diagnosis followed the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018);
  • MRS before onset was 0-1 points
  • Baseline NIHSS 5-25(both included);
  • Informed consent from the patient or surrogate.

Exclusion Criteria:

  • Intended to proceed endovascular treatment;
  • NIHSS consciousness score >2;
  • Allergy to tenecteplase or alteplase;
  • Past history of intracranial hemorrhage ;
  • A history of severe head trauma or stroke within 3 months;
  • A history of intracranial or spinal surgery within 3 months;
  • A history of gastrointestinal or urinary bleeding within 3 weeks;
  • 2 weeks of major surgery;
  • Arterial puncture was performed at the hemostasis site that was not easily compressed within 1 week;
  • Intracranial tumors (except neuroectodermal tumors, such as meningiomas), large intracranial aneurysms;
  • Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.);
  • Active visceral bleeding;
  • Aortic arch dissection was found;
  • After active antihypertensive treatment, hypertension is still not under control: systolic blood pressure ≥180 mm Hg, or diastolic blood pressure ≥100 mm Hg;
  • Propensity for acute bleeding, including platelet counts of less than 100×109/ L or otherwise;
  • Blood glucose <2.8 mmol/L or >22.22 mmol/L;
  • Oral warfarin anticoagulant with INR>1.7 or PT>15 s;
  • Heparin treatment was received within 24 h;
  • Thrombin inhibitors or factor Xa inhibitors were used within 48 h;
  • Head CT or MRI showed a large infarction (infarcted area > 1/3 of the middle cerebral artery);
  • Subjects who are unable or unwilling to cooperate due to hemiplegia (Todd's palsy) after epileptic seizure or other neurological/psychiatric disorders;
  • Pregnant women, lactating women, or subjects who do not agree to use effective contraception during the trial;
  • Participation in other clinical trials within 3 months prior to screening;
  • Unsuitability or participation in this study as judged by the Investigator may result in subjects being exposed to greater risk.

Sites / Locations

  • The first affiliated hospital of ustc
  • The people's hospltal of xuancheng city
  • Beijing luhe hospital capital medical university
  • Beijing Tiantan Hospital, Capital Medical University
  • Chongqing Three Gorges Central Hospital
  • The first hospital of lanzhou university
  • Guangdong Provincial Hospital of Traditional Chinese Medicine
  • Yue bei people's hospital
  • Guizhou provincial people's hospital
  • Affiliated hospital of chengde medical university
  • The first hospital of hebei medical university
  • the Third Hospital of Hebei Medical University
  • Tangshan Workers ' Hospital
  • The first affiliated hospital of hebei north university
  • Daqing Oilfield General Hospital
  • The 2ad affiliated hospital of harbin medical university
  • Second People's Hospital of Jiaozuo City
  • Nanyang central hospital
  • Nanyang Nanshi Hospital
  • Nayang second general hospital
  • Pingmei Shenma Medical Group General Hospital
  • Xinxiang first people's hospital
  • Xinyang central hospital
  • The first affiliated hospital of zhengzhou university
  • The central hospital of wuhan
  • Inner Mongolia Baotou Hospita
  • Affiliated Hospital of Chifeng University
  • Kashkten Mongolian Medicine Hospital
  • Inner Mongolia People'S Hospital
  • Huai an second people's hospital
  • Jiangsu taizhou people's hopital
  • General Hospital of Xuzhou Mining Group
  • Xuzhou central hospital
  • Third Affiliated Hospital of Nanchang University
  • First Hospital of Jilin University
  • Jilin neuropsychiaric hospital
  • Tonghua Central Hospital
  • Meihekou Central Hospital
  • The Firet Affiliated Hospital of Jinzhou Medical University
  • Central hospital affiliated to shenyang medical college
  • General Hospital of Northern War Zone, PLA
  • The first hospital of china medical university
  • The First People'S Hospital of Shenyang
  • Linyi City People Hospital
  • Tengzhou Central People's Hospital
  • Yantai Yuhuangding Hosopital
  • Huashan Hospital Affiliated to Fudan University
  • Heping hospital affiliated to changzhi medical college
  • General Hospital of Chinese Medicine and Coal
  • The fifth people's s hospital of datong
  • Linfen central hospital
  • Linfen people's hospital
  • First Hospital of Shanxi Medical University
  • Shanxi Cardiovascular Hospital
  • Xianyang Hospital of Yan ' an University
  • Mianyang central hospital
  • Shanxi provincial prople's hospital
  • The Second Affiliated Hospital Zhejiang University School of Medicine
  • Lishui Central Hospital
  • Taizhou Enze Medical Center ( Group )
  • Wenzhou Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

rhTNK-tPA (0.25mg/kg)

rt-PA (0.9mg/kg)

Arm Description

rhTNK-tPA (0.25mg/kg) is given as a single, intravenous bolus (within 5-10 seconds) immediately upon randomization. Maximum dose 25mg.

10% dose of rt-PA (0.9 mg/kg) is given as bolus and the remainder in 1 hour. Maximum dose 90mg.

Outcomes

Primary Outcome Measures

Excellent functional outcome
Proportion of subjects with mRS(0-1) at 90 days.

Secondary Outcome Measures

Good functional outcome
Proportion of subjects with mRS(0-2) at 90 days.
National Institutes of Health Stroke Scale (NIHSS)
Proportion of subjects with NIHSS score ≥ 4 improved compared with baseline at 24 or with NIHSS 0-1 at 24 hours and 7 days.
EQ-5D
Quality of life measured by EQ-5D scale.
Barthel (BI)
Global function of daily living defined as BI ≥ 95 at 90 days.
Modified Rankin Scale(mRS)
Ordinal distribution of mRS at 90 days.

Full Information

First Posted
February 25, 2021
Last Updated
January 13, 2023
Sponsor
Beijing Tiantan Hospital
Collaborators
Guangzhou Recomgen Biotech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04797013
Brief Title
Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅱ
Acronym
TRACEⅡ
Official Title
A Phase 3, Multicentre,Open-label, Randomised Controlled, Non-inferiority Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 12, 2021 (Actual)
Primary Completion Date
May 29, 2022 (Actual)
Study Completion Date
July 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
Collaborators
Guangzhou Recomgen Biotech 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
A Phase Ⅲ, Multicenter, Prospective, Randomized, Open Label, Blinded-endpoint (PROBE) Controlled Trial of Recombinant Human TNK Tissue-type Plasminogen Activator (rhTNK-tPA) for Injection Versus Alteplase for Acute Ischemic Stroke Within 4.5 Hours
Detailed Description
To test the hypothesis that rhTNK-tPA is non-inferior to alteplase in thrombolysis treatment when administered within 4.5 hours of ischemic stroke onset.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
rhTNK-tPA, acute, stroke, phaseⅢ, Acute Ischemic Stroke, rt-PA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
multicenter, prospective, randomized, open label, blinded-endpoint (PROBE)，Parallel controls，Non-inferiority
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1430 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rhTNK-tPA (0.25mg/kg)
Arm Type
Active Comparator
Arm Description
rhTNK-tPA (0.25mg/kg) is given as a single, intravenous bolus (within 5-10 seconds) immediately upon randomization. Maximum dose 25mg.
Arm Title
rt-PA (0.9mg/kg)
Arm Type
Active Comparator
Arm Description
10% dose of rt-PA (0.9 mg/kg) is given as bolus and the remainder in 1 hour. Maximum dose 90mg.
Intervention Type
Drug
Intervention Name(s)
rt-PA
Other Intervention Name(s)
Alteplase injection (rt-PA)
Intervention Description
Subjects will be randomized to rhTNK-tPA or rt-PA in a 1:1 ratio.
Intervention Type
Drug
Intervention Name(s)
rhTNK-tPA
Other Intervention Name(s)
Recombinant Human TNK Tissue-type Plasminogen Activator for Injection
Intervention Description
Subjects will be randomized to rhTNK-tPA or rt-PA in a 1:1 ratio.
Primary Outcome Measure Information:
Title
Excellent functional outcome
Description
Proportion of subjects with mRS(0-1) at 90 days.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Good functional outcome
Description
Proportion of subjects with mRS(0-2) at 90 days.
Time Frame
90 days
Title
National Institutes of Health Stroke Scale (NIHSS)
Description
Proportion of subjects with NIHSS score ≥ 4 improved compared with baseline at 24 or with NIHSS 0-1 at 24 hours and 7 days.
Time Frame
24 hours，day7
Title
EQ-5D
Description
Quality of life measured by EQ-5D scale.
Time Frame
90 days
Title
Barthel (BI)
Description
Global function of daily living defined as BI ≥ 95 at 90 days.
Time Frame
90 days
Title
Modified Rankin Scale(mRS)
Description
Ordinal distribution of mRS at 90 days.
Time Frame
90 days
Other Pre-specified Outcome Measures:
Title
Symptomatic intracranial hemorrhage(sICH)
Description
Proportion of subjects with symptomatic intracranial hemorrhage (sICH) at 36 hours.( defined by ECASSIII)
Time Frame
36 hours
Title
Asymptomatic intracranial hemorrhage
Description
The incidence of asymptomatic intracranial hemorrhage at 90 days.
Time Frame
90 days
Title
PH2 intracranial hemorrhage
Description
The incidence of PH2 intracranial hemorrhage within 90 days (according to SITS standards).
Time Frame
90 days
Title
Any intracranial hemorrhage
Description
The incidence of any intracranial hemorrhage within 90 days.
Time Frame
90 days
Title
Systematic bleeding
Description
The incidence of Systematic bleeding at 90 days.( defined by GUSTO）
Time Frame
90 days
Title
Deaths
Description
Rate of Overall mortality at 90 days.
Time Frame
90 days
Title
AEs/SAEs
Description
The incidence of adverse events(AEs) / severe adverse events(SAEs) at 90 days.
Time Frame
90 days

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years old, no gender limitation; 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"; The clinical diagnosis was ischemic stroke (the diagnosis followed the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018); MRS before onset was 0-1 points Baseline NIHSS 5-25(both included); Informed consent from the patient or surrogate. Exclusion Criteria: Intended to proceed endovascular treatment; NIHSS consciousness score >2; Allergy to tenecteplase or alteplase; Past history of intracranial hemorrhage ; A history of severe head trauma or stroke within 3 months; A history of intracranial or spinal surgery within 3 months; A history of gastrointestinal or urinary bleeding within 3 weeks; 2 weeks of major surgery; Arterial puncture was performed at the hemostasis site that was not easily compressed within 1 week; Intracranial tumors (except neuroectodermal tumors, such as meningiomas), large intracranial aneurysms; Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.); Active visceral bleeding; Aortic arch dissection was found; After active antihypertensive treatment, hypertension is still not under control: systolic blood pressure ≥180 mm Hg, or diastolic blood pressure ≥100 mm Hg; Propensity for acute bleeding, including platelet counts of less than 100×109/ L or otherwise; Blood glucose <2.8 mmol/L or >22.22 mmol/L; Oral warfarin anticoagulant with INR>1.7 or PT>15 s; Heparin treatment was received within 24 h; Thrombin inhibitors or factor Xa inhibitors were used within 48 h; Head CT or MRI showed a large infarction (infarcted area > 1/3 of the middle cerebral artery); Subjects who are unable or unwilling to cooperate due to hemiplegia (Todd's palsy) after epileptic seizure or other neurological/psychiatric disorders; Pregnant women, lactating women, or subjects who do not agree to use effective contraception during the trial; Participation in other clinical trials within 3 months prior to screening; Unsuitability or participation in this study as judged by the Investigator may result in subjects being exposed to greater risk.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Sun
Organizational Affiliation
IRB of Beijing Tiantan Hospital,Capital Medical University
Official's Role
Study Director
Facility Information:
Facility Name
The first affiliated hospital of ustc
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Facility Name
The people's hospltal of xuancheng city
City
Xuancheng
State/Province
Anhui
ZIP/Postal Code
242000
Country
China
Facility Name
Beijing luhe hospital capital medical university
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Chongqing Three Gorges Central Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
404100
Country
China
Facility Name
The first hospital of lanzhou university
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Facility Name
Guangdong Provincial Hospital of Traditional Chinese Medicine
City
Guangdong
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Yue bei people's hospital
City
Shaoguan
State/Province
Guangdong
ZIP/Postal Code
512000
Country
China
Facility Name
Guizhou provincial people's hospital
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550000
Country
China
Facility Name
Affiliated hospital of chengde medical university
City
Chengde
State/Province
Hebei
ZIP/Postal Code
067000
Country
China
Facility Name
The first hospital of hebei medical university
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
the Third Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
Tangshan Workers ' Hospital
City
Tangshan
State/Province
Hebei
ZIP/Postal Code
063000
Country
China
Facility Name
The first affiliated hospital of hebei north university
City
Zhangjiakou
State/Province
Hebei
ZIP/Postal Code
075000
Country
China
Facility Name
Daqing Oilfield General Hospital
City
Daqing
State/Province
Heilongjiang
ZIP/Postal Code
163000
Country
China
Facility Name
The 2ad affiliated hospital of harbin medical university
City
Haerbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Facility Name
Second People's Hospital of Jiaozuo City
City
Jiaozuo
State/Province
Henan
ZIP/Postal Code
454150
Country
China
Facility Name
Nanyang central hospital
City
Nanyang
State/Province
Henan
ZIP/Postal Code
473000
Country
China
Facility Name
Nanyang Nanshi Hospital
City
Nanyang
State/Province
Henan
ZIP/Postal Code
473000
Country
China
Facility Name
Nayang second general hospital
City
Nanyang
State/Province
Henan
ZIP/Postal Code
473000
Country
China
Facility Name
Pingmei Shenma Medical Group General Hospital
City
Pingdingshan
State/Province
Henan
ZIP/Postal Code
467000
Country
China
Facility Name
Xinxiang first people's hospital
City
Xinxiang
State/Province
Henan
ZIP/Postal Code
453000
Country
China
Facility Name
Xinyang central hospital
City
Xinyang
State/Province
Henan
ZIP/Postal Code
464000
Country
China
Facility Name
The first affiliated hospital of zhengzhou university
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Name
The central hospital of wuhan
City
Wuhan
State/Province
Hunan
ZIP/Postal Code
430000
Country
China
Facility Name
Inner Mongolia Baotou Hospita
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014
Country
China
Facility Name
Affiliated Hospital of Chifeng University
City
Chifeng
State/Province
Inner Mongolia
ZIP/Postal Code
024000
Country
China
Facility Name
Kashkten Mongolian Medicine Hospital
City
Chifeng
State/Province
Inner Mongolia
ZIP/Postal Code
024000
Country
China
Facility Name
Inner Mongolia People'S Hospital
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
010000
Country
China
Facility Name
Huai an second people's hospital
City
Huaian
State/Province
Jiangsu
ZIP/Postal Code
223001
Country
China
Facility Name
Jiangsu taizhou people's hopital
City
Taizhou
State/Province
Jiangsu
ZIP/Postal Code
225300
Country
China
Facility Name
General Hospital of Xuzhou Mining Group
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Facility Name
Xuzhou central hospital
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Facility Name
Third Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330000
Country
China
Facility Name
First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130
Country
China
Facility Name
Jilin neuropsychiaric hospital
City
Siping
State/Province
Jilin
ZIP/Postal Code
136000
Country
China
Facility Name
Tonghua Central Hospital
City
Tonghua
State/Province
Jilin
ZIP/Postal Code
134000
Country
China
Facility Name
Meihekou Central Hospital
City
Tonghua
State/Province
Jilin
ZIP/Postal Code
135000
Country
China
Facility Name
The Firet Affiliated Hospital of Jinzhou Medical University
City
Jinzhou
State/Province
Liaoning
ZIP/Postal Code
121000
Country
China
Facility Name
Central hospital affiliated to shenyang medical college
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Facility Name
General Hospital of Northern War Zone, PLA
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Facility Name
The first hospital of china medical university
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Facility Name
The First People'S Hospital of Shenyang
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Facility Name
Linyi City People Hospital
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276000
Country
China
Facility Name
Tengzhou Central People's Hospital
City
Tengzhou
State/Province
Shandong
ZIP/Postal Code
277559
Country
China
Facility Name
Yantai Yuhuangding Hosopital
City
Yantai
State/Province
Shandong
ZIP/Postal Code
264000
Country
China
Facility Name
Huashan Hospital Affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Heping hospital affiliated to changzhi medical college
City
Changzhi
State/Province
Shanxi
ZIP/Postal Code
046000
Country
China
Facility Name
General Hospital of Chinese Medicine and Coal
City
Datong
State/Province
Shanxi
ZIP/Postal Code
037000
Country
China
Facility Name
The fifth people's s hospital of datong
City
Datong
State/Province
Shanxi
ZIP/Postal Code
037000
Country
China
Facility Name
Linfen central hospital
City
Linfen
State/Province
Shanxi
ZIP/Postal Code
041000
Country
China
Facility Name
Linfen people's hospital
City
Linfen
State/Province
Shanxi
ZIP/Postal Code
041000
Country
China
Facility Name
First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030000
Country
China
Facility Name
Shanxi Cardiovascular Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030000
Country
China
Facility Name
Xianyang Hospital of Yan ' an University
City
Xianyang
State/Province
Shanxi
ZIP/Postal Code
712000
Country
China
Facility Name
Mianyang central hospital
City
Mianyang
State/Province
Sichuan
ZIP/Postal Code
621000
Country
China
Facility Name
Shanxi provincial prople's hospital
City
Taiyuan
State/Province
Taiyuan
ZIP/Postal Code
030000
Country
China
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Facility Name
Lishui Central Hospital
City
Lishui
State/Province
Zhejiang
ZIP/Postal Code
323000
Country
China
Facility Name
Taizhou Enze Medical Center ( Group )
City
Taizhou
State/Province
Zhejiang
ZIP/Postal Code
318000
Country
China
Facility Name
Wenzhou Central Hospital
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32078683
Citation
Campbell BCV, Mitchell PJ, Churilov L, Yassi N, Kleinig TJ, Dowling RJ, Yan B, Bush SJ, Thijs V, Scroop R, Simpson M, Brooks M, Asadi H, Wu TY, Shah DG, Wijeratne T, Zhao H, Alemseged F, Ng F, Bailey P, Rice H, de Villiers L, Dewey HM, Choi PMC, Brown H, Redmond K, Leggett D, Fink JN, Collecutt W, Kraemer T, Krause M, Cordato D, Field D, Ma H, O'Brien B, Clissold B, Miteff F, Clissold A, Cloud GC, Bolitho LE, Bonavia L, Bhattacharya A, Wright A, Mamun A, O'Rourke F, Worthington J, Wong AA, Levi CR, Bladin CF, Sharma G, Desmond PM, Parsons MW, Donnan GA, Davis SM; EXTEND-IA TNK Part 2 investigators. Effect of Intravenous Tenecteplase Dose on Cerebral Reperfusion Before Thrombectomy in Patients With Large Vessel Occlusion Ischemic Stroke: The EXTEND-IA TNK Part 2 Randomized Clinical Trial. JAMA. 2020 Apr 7;323(13):1257-1265. doi: 10.1001/jama.2020.1511. Erratum In: JAMA. 2022 Mar 8;327(10):985.
Results Reference
background
PubMed Identifier
31318627
Citation
Burgos AM, Saver JL. Evidence that Tenecteplase Is Noninferior to Alteplase for Acute Ischemic Stroke: Meta-Analysis of 5 Randomized Trials. Stroke. 2019 Aug;50(8):2156-2162. doi: 10.1161/STROKEAHA.119.025080. Epub 2019 Jul 18.
Results Reference
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PubMed Identifier
18815396
Citation
Hacke W, Kaste M, Bluhmki E, Brozman M, Davalos A, Guidetti D, Larrue V, Lees KR, Medeghri Z, Machnig T, Schneider D, von Kummer R, Wahlgren N, Toni D; ECASS Investigators. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008 Sep 25;359(13):1317-29. doi: 10.1056/NEJMoa0804656.
Results Reference
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PubMed Identifier
31128925
Citation
Campbell BCV, Ma H, Ringleb PA, Parsons MW, Churilov L, Bendszus M, Levi CR, Hsu C, Kleinig TJ, Fatar M, Leys D, Molina C, Wijeratne T, Curtze S, Dewey HM, Barber PA, Butcher KS, De Silva DA, Bladin CF, Yassi N, Pfaff JAR, Sharma G, Bivard A, Desmond PM, Schwab S, Schellinger PD, Yan B, Mitchell PJ, Serena J, Toni D, Thijs V, Hacke W, Davis SM, Donnan GA; EXTEND, ECASS-4, and EPITHET Investigators. Extending thrombolysis to 4.5-9 h and wake-up stroke using perfusion imaging: a systematic review and meta-analysis of individual patient data. Lancet. 2019 Jul 13;394(10193):139-147. doi: 10.1016/S0140-6736(19)31053-0. Epub 2019 May 22. Erratum In: Lancet. 2020 Jun 20;395(10241):1906.
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Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅱ

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