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

January 13, 2023 updated by: Yongjun Wang, Beijing Tiantan Hospital

A Phase 3, Multicentre,Open-label, Randomised Controlled, Non-inferiority Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1430

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 Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • The First Affiliated hospital of USTC
      • Xuancheng, Anhui, China, 242000
        • The people's hospltal of xuancheng city
    • Beijing
      • Beijing, Beijing, China, 100000
        • Beijing Luhe Hospital Capital Medical University
      • Beijing, Beijing, China, 100000
        • Beijing Tiantan Hospital, Capital Medical University
    • Chongqing
      • Chongqing, Chongqing, China, 404100
        • Chongqing Three Gorges Central Hospital
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • The First Hospital of Lanzhou University
    • Guangdong
      • Guangdong, Guangdong, China, 510000
        • Guangdong Provincial Hospital of Traditional Chinese Medicine
      • Shaoguan, Guangdong, China, 512000
        • Yue Bei People's Hospital
    • Guizhou
      • Guiyang, Guizhou, China, 550000
        • Guizhou Provincial People's Hospital
    • Hebei
      • Chengde, Hebei, China, 067000
        • Affiliated Hospital of Chengde Medical University
      • Shijiazhuang, Hebei, China, 050000
        • The Third Hospital of Hebei Medical University
      • Shijiazhuang, Hebei, China, 050000
        • The First Hospital of Hebei Medical University
      • Tangshan, Hebei, China, 063000
        • Tangshan Workers ' Hospital
      • Zhangjiakou, Hebei, China, 075000
        • The First Affiliated Hospital of Hebei North University
    • Heilongjiang
      • Daqing, Heilongjiang, China, 163000
        • Daqing Oilfield General Hospital
      • Haerbin, Heilongjiang, China, 150000
        • The 2ad affiliated hospital of harbin medical university
    • Henan
      • Jiaozuo, Henan, China, 454150
        • Second People's Hospital of Jiaozuo City
      • Nanyang, Henan, China, 473000
        • Nanyang Central Hospital
      • Nanyang, Henan, China, 473000
        • Nanyang Nanshi Hospital
      • Nanyang, Henan, China, 473000
        • Nayang second general hospital
      • Pingdingshan, Henan, China, 467000
        • Pingmei Shenma medical group general hospital
      • Xinxiang, Henan, China, 453000
        • Xinxiang First People's Hospital
      • Xinyang, Henan, China, 464000
        • Xinyang Central Hospital
      • Zhengzhou, Henan, China, 450000
        • the First Affiliated Hospital of Zhengzhou University
    • Hunan
      • Wuhan, Hunan, China, 430000
        • The Central Hospital of Wuhan
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014
        • Inner Mongolia Baotou Hospita
      • Chifeng, Inner Mongolia, China, 024000
        • Affiliated Hospital of Chifeng University
      • Chifeng, Inner Mongolia, China, 024000
        • Kashkten Mongolian Medicine Hospital
      • Hohhot, Inner Mongolia, China, 010000
        • Inner Mongolia People's Hospital
    • Jiangsu
      • Huaian, Jiangsu, China, 223001
        • Huai an second people's hospital
      • Taizhou, Jiangsu, China, 225300
        • Jiangsu taizhou people's hopital
      • Xuzhou, Jiangsu, China, 221000
        • Xuzhou Central Hospital
      • Xuzhou, Jiangsu, China, 221000
        • General Hospital of Xuzhou Mining Group
    • Jiangxi
      • Nanchang, Jiangxi, China, 330000
        • Third Affiliated Hospital of Nanchang University
    • Jilin
      • Changchun, Jilin, China, 130
        • First Hospital of Jilin University
      • Siping, Jilin, China, 136000
        • Jilin neuropsychiaric hospital
      • Tonghua, Jilin, China, 135000
        • Meihekou Central Hospital
      • Tonghua, Jilin, China, 134000
        • Tonghua Central Hospital
    • Liaoning
      • Jinzhou, Liaoning, China, 121000
        • The Firet Affiliated Hospital of Jinzhou Medical University
      • Shenyang, Liaoning, China, 110000
        • The First Hospital of China Medical University
      • Shenyang, Liaoning, China, 110000
        • Central Hospital Affiliated to Shenyang Medical College
      • Shenyang, Liaoning, China, 110000
        • General Hospital of Northern War Zone, PLA
      • Shenyang, Liaoning, China, 110000
        • The first people's hospital of Shenyang
    • Shandong
      • Linyi, Shandong, China, 276000
        • Linyi City People Hospital
      • Tengzhou, Shandong, China, 277559
        • Tengzhou Central People's Hospital
      • Yantai, Shandong, China, 264000
        • Yantai Yuhuangding Hosopital
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Huashan Hospital Affiliated to Fudan University
    • Shanxi
      • Changzhi, Shanxi, China, 046000
        • Heping Hospital Affiliated to Changzhi Medical College
      • Datong, Shanxi, China, 037000
        • General Hospital of Chinese Medicine and Coal
      • Datong, Shanxi, China, 037000
        • The fifth people's s hospital of datong
      • Linfen, Shanxi, China, 041000
        • Linfen People's Hospital
      • Linfen, Shanxi, China, 041000
        • Linfen Central Hospital
      • Taiyuan, Shanxi, China, 030000
        • First Hospital of Shanxi Medical University
      • Taiyuan, Shanxi, China, 030000
        • Shanxi Cardiovascular Hospital
      • Xianyang, Shanxi, China, 712000
        • Xianyang Hospital of Yan ' an University
    • Sichuan
      • Mianyang, Sichuan, China, 621000
        • Mianyang Central Hospital
    • Taiyuan
      • Taiyuan, Taiyuan, China, 030000
        • Shanxi provincial prople's hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • the Second Affiliated Hospital Zhejiang University School of Medicine
      • Lishui, Zhejiang, China, 323000
        • Lishui Central Hospital
      • Taizhou, Zhejiang, China, 318000
        • Taizhou Enze Medical Center ( Group )
      • Wenzhou, Zhejiang, China, 325000
        • Wenzhou Central Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: rhTNK-tPA (0.25mg/kg)
rhTNK-tPA (0.25mg/kg) is given as a single, intravenous bolus (within 5-10 seconds) immediately upon randomization. Maximum dose 25mg.
Drug: rhTNK-tPA
Subjects will be randomized to rhTNK-tPA or rt-PA in a 1:1 ratio.
Other Names:
  • Recombinant Human TNK Tissue-type Plasminogen Activator for Injection
Active Comparator: rt-PA (0.9mg/kg)
10% dose of rt-PA (0.9 mg/kg) is given as bolus and the remainder in 1 hour. Maximum dose 90mg.
Drug: rt-PA
Subjects will be randomized to rhTNK-tPA or rt-PA in a 1:1 ratio.
Other Names:
  • Alteplase injection (rt-PA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Excellent functional outcome
Time Frame: 90 days
Proportion of subjects with mRS(0-1) at 90 days.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EQ-5D
Time Frame: 90 days
Quality of life measured by EQ-5D scale.
90 days
Barthel (BI)
Time Frame: 90 days
Global function of daily living defined as BI ≥ 95 at 90 days.
90 days
Modified Rankin Scale(mRS)
Time Frame: 90 days
Ordinal distribution of mRS at 90 days.
90 days
Good functional outcome
Time Frame: 90 days
Proportion of subjects with mRS(0-2) at 90 days.
90 days
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: 24 hours，day7
Proportion of subjects with NIHSS score ≥ 4 improved compared with baseline at 24 or with NIHSS 0-1 at 24 hours and 7 days.
24 hours，day7

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptomatic intracranial hemorrhage(sICH)
Time Frame: 36 hours
Proportion of subjects with symptomatic intracranial hemorrhage (sICH) at 36 hours.( defined by ECASSIII)
36 hours
Asymptomatic intracranial hemorrhage
Time Frame: 90 days
The incidence of asymptomatic intracranial hemorrhage at 90 days.
90 days
PH2 intracranial hemorrhage
Time Frame: 90 days
The incidence of PH2 intracranial hemorrhage within 90 days (according to SITS standards).
90 days
Any intracranial hemorrhage
Time Frame: 90 days
The incidence of any intracranial hemorrhage within 90 days.
90 days
Systematic bleeding
Time Frame: 90 days
The incidence of Systematic bleeding at 90 days.( defined by GUSTO）
90 days
Deaths
Time Frame: 90 days
Rate of Overall mortality at 90 days.
90 days
AEs/SAEs
Time Frame: 90 days
The incidence of adverse events(AEs) / severe adverse events(SAEs) at 90 days.
90 days

Collaborators and Investigators

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

Sponsor

Beijing Tiantan Hospital

Collaborators

Guangzhou Recomgen Biotech Co., Ltd.

Investigators

  • Study Director: Wei Sun, 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)

June 12, 2021

Primary Completion (Actual)

May 29, 2022

Study Completion (Actual)

July 15, 2022

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

March 10, 2021

First Posted (Actual)

March 15, 2021

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MK02-2020-01

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.

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