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TRACEⅡ: Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅱ

Sponsor
Beijing Tiantan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04797013
Collaborator
Guangzhou Recomgen Biotech Co., Ltd. (Industry)
1,430
Enrollment
61
Locations
2
Arms
31
Anticipated Duration (Months)
23.4
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1430 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
multicenter, prospective, randomized, open label, blinded-endpoint (PROBE)，Parallel controls，Non-inferioritymulticenter, prospective, randomized, open label, blinded-endpoint (PROBE)，Parallel controls，Non-inferiority
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Mar 31, 2021
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Modified Rankin Scale(mRS) [90 days]

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

    Secondary Outcome Measures

    1. Modified Rankin Scale(mRS) [90 days]

      Proportion of subjects with mRS(0-2) at 90 days.

    2. National Institutes of Health Stroke Scale (NIHSS) [24 hours，day7]

      Proportion of subjects with NIHSS 0-1 at 24 hours and 7 days.

    3. EQ-5D [90 days]

      Quality of life measured by EQ-5D scale.

    4. Barthel (BI) [90 days]

      Global function of daily living defined as BI ≥ 95 at 90 days.

    5. Modified Rankin Scale(mRS) [90 days]

      Ordinal distribution of mRS at 90 days.

    6. National Institutes of Health Stroke Scale (NIHSS) [24 hours，day7]

      Proportion of subjects with NIHSS score ≥ 4 improved compared with baseline at 24 hours and 7 days.

    Other Outcome Measures

    1. Symptomatic intracranial hemorrhage(sICH) [36 hours]

      Proportion of subjects with symptomatic intracranial hemorrhage (sICH) at 36 hours.( defined by ECASSIII)

    2. Asymptomatic intracranial hemorrhage [90 days]

      The incidence of asymptomatic intracranial hemorrhage at 90 days.

    3. PH2 intracranial hemorrhage [90 days]

      The incidence of PH2 intracranial hemorrhage within 90 days (according to SITS standards).

    4. Any intracranial hemorrhage [90 days]

      The incidence of any intracranial hemorrhage within 90 days.

    5. Systematic bleeding [90 days]

      The incidence of Systematic bleeding at 90 days.( defined by GUSTO）

    6. Deaths [90 days]

      Rate of Overall mortality at 90 days.

    7. AEs/SAEs [90 days]

      The incidence of adverse events(AEs) / severe adverse events(SAEs) at 90 days.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The first affiliated hospital of ustc Hefei Anhui China 230000
    2 The people's hospltal of xuancheng city Xuancheng Anhui China 242000
    3 Beijing luhe hospital capital medical university Beijing Beijing China 100000
    4 Beijing Tiantan Hospital, Capital Medical University Beijing Beijing China 100000
    5 Chongqing Three Gorges Central Hospital Chongqing Chongqing China 404100
    6 The first hospital of lanzhou university Lanzhou Gansu China 730000
    7 Guangdong Provincial Hospital of Traditional Chinese Medicine Guangdong Guangdong China 510000
    8 Yue bei people's hospital Shaoguan Guangdong China 512000
    9 Guizhou provincial people's hospital Guiyang Guizhou China 550000
    10 Affiliated hospital of chengde medical university Chengde Hebei China 067000
    11 The first hospital of hebei medical university Shijiazhuang Hebei China 050000
    12 the Third Hospital of Hebei Medical University Shijiazhuang Hebei China 050000
    13 Tangshan Workers ' Hospital Tangshan Hebei China 063000
    14 The first affiliated hospital of hebei north university Zhangjiakou Hebei China 075000
    15 Daqing Oilfield General Hospital Daqing Heilongjiang China 163000
    16 The 2ad affiliated hospital of harbin medical university Haerbin Heilongjiang China 150000
    17 Second People's Hospital of Jiaozuo City Jiaozuo Henan China 454150
    18 Nanyang central hospital Nanyang Henan China 473000
    19 Nanyang Nanshi Hospital Nanyang Henan China 473000
    20 Nayang second general hospital Nanyang Henan China 473000
    21 Pingmei Shenma Medical Group General Hospital Pingdingshan Henan China 467000
    22 Xinxiang first people's hospital Xinxiang Henan China 453000
    23 Xinyang central hospital Xinyang Henan China 464000
    24 The first affiliated hospital of zhengzhou university Zhengzhou Henan China 450000
    25 The central hospital of wuhan Wuhan Hunan China 430000
    26 Inner Mongolia Baotou Hospita Baotou Inner Mongolia China 014
    27 Affiliated Hospital of Chifeng University Chifeng Inner Mongolia China 024000
    28 Kashkten Mongolian Medicine Hospital Chifeng Inner Mongolia China 024000
    29 Inner Mongolia People'S Hospital Hohhot Inner Mongolia China 010000
    30 Huai an second people's hospital Huaian Jiangsu China 223001
    31 Jiangsu taizhou people's hopital Taizhou Jiangsu China 225300
    32 General Hospital of Xuzhou Mining Group Xuzhou Jiangsu China 221000
    33 Xuzhou central hospital Xuzhou Jiangsu China 221000
    34 Third Affiliated Hospital of Nanchang University Nanchang Jiangxi China 330000
    35 First Hospital of Jilin University Changchun Jilin China 130
    36 Jilin neuropsychiaric hospital Siping Jilin China 136000
    37 Tonghua Central Hospital Tonghua Jilin China 134000
    38 Meihekou Central Hospital Tonghua Jilin China 135000
    39 The Firet Affiliated Hospital of Jinzhou Medical University Jinzhou Liaoning China 121000
    40 Central hospital affiliated to shenyang medical college Shenyang Liaoning China 110000
    41 General Hospital of Northern War Zone, PLA Shenyang Liaoning China 110000
    42 The first hospital of china medical university Shenyang Liaoning China 110000
    43 The First People'S Hospital of Shenyang Shenyang Liaoning China 110000
    44 Linyi City People Hospital Linyi Shandong China 276000
    45 Tengzhou Central People's Hospital Tengzhou Shandong China 277559
    46 Yantai Yuhuangding Hosopital Yantai Shandong China 264000
    47 Huashan Hospital Affiliated to Fudan University Shanghai Shanghai China 200000
    48 Heping hospital affiliated to changzhi medical college Changzhi Shanxi China 046000
    49 General Hospital of Chinese Medicine and Coal Datong Shanxi China 037000
    50 The fifth people's s hospital of datong Datong Shanxi China 037000
    51 Linfen central hospital Linfen Shanxi China 041000
    52 Linfen people's hospital Linfen Shanxi China 041000
    53 First Hospital of Shanxi Medical University Taiyuan Shanxi China 030000
    54 Shanxi Cardiovascular Hospital Taiyuan Shanxi China 030000
    55 Xianyang Hospital of Yan ' an University Xianyang Shanxi China 712000
    56 Mianyang central hospital Mianyang Sichuan China 621000
    57 Shanxi provincial prople's hospital Taiyuan Taiyuan China 030000
    58 The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou Zhejiang China 310000
    59 Lishui Central Hospital Lishui Zhejiang China 323000
    60 Taizhou Enze Medical Center ( Group ) Taizhou Zhejiang China 318000
    61 Wenzhou Central Hospital Wenzhou Zhejiang China 325000

    Sponsors and Collaborators

    • Beijing Tiantan Hospital
    • Guangzhou Recomgen Biotech Co., Ltd.

    Investigators

    • Study Director: Wei Sun, IRB of Beijing Tiantan Hospital,Capital Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Yongjun Wang, President of Beijing Tiantan Hospital, Capital Medical University, Director of Neurology Center, Beijing Tiantan Hospital
    ClinicalTrials.gov Identifier:
    NCT04797013
    Other Study ID Numbers:
    • MK02-2020-01
    First Posted:
    Mar 15, 2021
    Last Update Posted:
    Jul 28, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yongjun Wang, President of Beijing Tiantan Hospital, Capital Medical University, Director of Neurology Center, Beijing Tiantan Hospital
    rhTNK-tPA
    acute
    stroke
    phaseⅢ
    Acute Ischemic Stroke
    rt-PA
    Additional relevant MeSH terms:
    Stroke
    Ischemic Stroke
    Ischemia
    Tissue Plasminogen Activator
    Plasminogen

    Study Results

    No Results Posted as of Jul 28, 2021