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Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events(TRACE)

Primary Purpose

Acute Ischemic Stroke

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TNK-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, phaseII, Acute Ischemic Stroke, rt-PA

Eligibility Criteria

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

Inclusion Criteria:

  1. Age over 18 years.
  2. Time from onset to treatment < 3 hours; the time symptoms start is defined as "the last moment they appear normal".
  3. Diagnosis of ischemic stroke according to "2014 China Guideline for Diagnosis and Treatment of Acute Ischemic Stroke" with assessable neurological impairment e.g., language, motor function, cognitive impairment, gaze impairment, visual field deficit and/or visual neglect. Ischemic stroke is defined as sudden acute focal neurological impairment with suspected cerebral ischemia, hemorrhage ruled out by CT scan.
  4. mRS > 2 at the first onset or prior onset.
  5. Baseline NIHSS score is > 4 and < 26.
  6. Signed informed consent.

Exclusion Criteria:

  1. Absolute contraindications:

    1.1 History of severe head trauma or stroke within 3 months; 1.2 Suspected subarachnoid hemorrhage; 1.3 Arterial puncture at a non-compressible site within the previous 1week; 1.4 History of intracranial hemorrhage; 1.5 Intracranial tumor, vascular malformation, or arterial aneurysm; 1.6 Recent intracranial or intraspinal surgery; 1.7 Systolic blood pressure ≧ 180 mm Hg, or diastolic blood pressure ≧ 100 mm Hg; Increased blood pressure; 1.8 Active internal bleeding ; 1.9 Acute bleeding tendency, including platelet count below 100×109/L or otherwise; 1.10 Heparin treatment was performed within 48 h ( APTT exceeded the upper limit of normal range ) ; 1.11 Warfarin has been taken orally , and the international standardized ratio is INR > 1.7 or PT > 15 s ; 1.12 Anticoagulant drugs such as thrombin inhibitor or Xa factor inhibitor , argatroban ( including new anticoagulants with unclear mechanism ) are currently being used , and various sensitive laboratory tests are abnormal ( such as live ) APTT , INR , Platelet count , Serpentine ECT of pulse enzyme setting time ; thrombin time TT or appropriate determination of Xa factor activity ) ; 1.13 Blood glucose < 2.7 mmol/L; 1.14 CT showed multilobular infarction ( low density > 1 / 3 cerebral hemisphere )

  2. Relative contraindications : The risks and benefits of thrombolysis should be carefully considered and weighed in the following cases ( that is , although there is one or more relative contraindications , it is not absolutely impossible to thrombolysis ).

    2.1 Mild stroke or stroke with rapid improvement of symptoms; 2.2 Women in pregnancy ; 2.3 Symptoms of neurological impairment after seizures ; 2.4 There have been major surgical operations or serious injuries in the last 2 weeks; 2.5 There were gastrointestinal or urinary system bleeding in recent 3 weeks ; 2.6 History of myocardial infarction within 3 months.

  3. Have been enrolled in rhTNK-tPA in pre-study or participated in other clinical trials within 3 months prior to screening.
  4. Lactating women, or childbearing women who do not use effective contraception.
  5. Known allergy to rhTNK-tPA and/or rt-PA or relevant excipients.
  6. The researchers judged that not suitable to participate in this study or participate in this study may lead to greater risk for patients ;
  7. Can not comply with the test program or follow-up requirements .

Sites / Locations

  • Beijing Tiantan Hospital, Capital Medical University
  • The Ninth People's Hospital of Chongqing
  • First Affiliated Hospital of Jinan University
  • ShenZhen Hospital ,Beijing University
  • Affiliated Hosptial to GuiZhou Medical University
  • HaiNan Provincial People's Hospital
  • Hebei Medical University Third Hospital
  • Tangshan Workers' Hospital
  • The First Hospital Of Qiqihar
  • Luoyang First People's Hosptical
  • 1st Hospital Affiliated to Zhengzhou University
  • ChangSha 1st Municipal Hospital
  • Baotou Central Hospital
  • Inner Mongolia BaoGang Hospital
  • Huai'an Second People's Hospital
  • First Hospital of Jilin University
  • Meihekou Central Hospital
  • First People 's Hospital Of Shenyang
  • General Hospital of Northern War Zone , PLA
  • Linyi People's Hospital
  • Yantai Yuhuangding Hospital
  • HuaShan Hospital Affiliated to FuDan University
  • ZhongShan Hospital ,FuDan University
  • SiChuan University HuaXi Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Group 1 (rhTNK-tPA 0.10 mg/kg)

Group 2 (rhTNK-tPA 0.25 mg/kg)

Group 3 (rhTNK-tPA 0.32 mg/kg)

Group 4 (rt-PA 0.9 mg/kg)

Arm Description

Dissolve one vial of rhTNK-tPA in 3 ml sterile water for injection to prepare a solution of 5.33 mg/ml. Calculate the required volume according to the body weight of the subject, then measure the required volume. Administer as a single 0.10 mg/kg IV bolus over 5-10 seconds.

Dissolve one vial of rhTNK-tPA in 3 ml sterile water for injection to prepare a solution of 5.33 mg/ml. Calculate the required volume according to the body weight of the subject, then measure the required volume. Administer as a single 0.25 mg/kg IV bolus over 5-10 seconds.

Dissolve one vial of rhTNK-tPA in 3 ml sterile water for injection to prepare a solution of 5.33 mg/ml. Calculate the required volume according to the body weight of the subject, then measure the required volume. Administer as a single 0.32 mg/kg IV bolus over 5-10 seconds.

10% of rt-PA 0.9 mg/kg administered as an initial IV bolus followed by the remaining 90% as an IV infusion over the next 1 hour.

Outcomes

Primary Outcome Measures

National Institutes of Health Stroke Scale (NIHSS)
Proportion of subjects with NIHSS 1 or at least 4 on the NIHSS score decreased from the baseline at day14.

Secondary Outcome Measures

Modified Rankin Scale (mRS)
Proportion of subjects of excellent outcome defined as mRS (0-1) at 90 days. Ordinal distribution of mRS and change of proportion of subjects with mRS (0-2) at 90 days.
National Institutes of Health Stroke Scale (NIHSS)
Neurological impairment defined as change of NIHSS score at 90 days.
Barthel(BI)
Global function of daily living defined as BI ≥ 95 at 90 days.
EQ-5D
Quality of life measured by EQ-5D scale.

Full Information

First Posted
July 27, 2020
Last Updated
December 18, 2020
Sponsor
Beijing Tiantan Hospital
Collaborators
Guangzhou Recomgen Biotech Co., Ltd., The First Hospital Of Qiqihar, Hebei Medical University Third Hospital, Yantai Yuhuangding Hospital, Fudan University, First Affiliated Hospital of Jinan University, The First Hospital of Jilin University, Huashan Hospital, West China Hospital, Inner Mongolia Baogang Hospital, Linyi People's Hospital, The First Affiliated Hospital of Zhengzhou University, Baotou Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04676659
Brief Title
Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events(TRACE)
Official Title
Phase II Dose-finding Open Study of Recombinant Human TNK Tissue-type Plasminogen Activator (rhTNK-tPA) Injection Administered Within 3 Hours After Onset of Hyperacute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 12, 2018 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
July 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
Collaborators
Guangzhou Recomgen Biotech Co., Ltd., The First Hospital Of Qiqihar, Hebei Medical University Third Hospital, Yantai Yuhuangding Hospital, Fudan University, First Affiliated Hospital of Jinan University, The First Hospital of Jilin University, Huashan Hospital, West China Hospital, Inner Mongolia Baogang Hospital, Linyi People's Hospital, The First Affiliated Hospital of Zhengzhou University, Baotou Central Hospital

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
To explore the safe and efficacious dose of rhTNK-tPA injection administered within 3 hours after onset of hyperacute ischemic stroke; to provide dose evidence for phase III clinical trial.
Detailed Description
To evaluate the safety and efficacy of rhTNK-tPA at different doses of 0.10 mg/kg, 0.25 mg/kg and 0.32 mg/kg compared with standard rt-PA intravenous thrombolytic therapy within 3 hours after onset of ischemic stroke. The primary objective of this study is to evaluate the differences of NIHSS scores among the four treatment groups at 14 days after intravenous thrombolysis.

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, phaseII, Acute Ischemic Stroke, rt-PA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Multicentre, prospective, randomization, open label, active and parallel control
Masking
Outcomes Assessor
Masking Description
open to patient, medical cares, and investigators, but blind to outcome evaluators
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (rhTNK-tPA 0.10 mg/kg)
Arm Type
Experimental
Arm Description
Dissolve one vial of rhTNK-tPA in 3 ml sterile water for injection to prepare a solution of 5.33 mg/ml. Calculate the required volume according to the body weight of the subject, then measure the required volume. Administer as a single 0.10 mg/kg IV bolus over 5-10 seconds.
Arm Title
Group 2 (rhTNK-tPA 0.25 mg/kg)
Arm Type
Experimental
Arm Description
Dissolve one vial of rhTNK-tPA in 3 ml sterile water for injection to prepare a solution of 5.33 mg/ml. Calculate the required volume according to the body weight of the subject, then measure the required volume. Administer as a single 0.25 mg/kg IV bolus over 5-10 seconds.
Arm Title
Group 3 (rhTNK-tPA 0.32 mg/kg)
Arm Type
Experimental
Arm Description
Dissolve one vial of rhTNK-tPA in 3 ml sterile water for injection to prepare a solution of 5.33 mg/ml. Calculate the required volume according to the body weight of the subject, then measure the required volume. Administer as a single 0.32 mg/kg IV bolus over 5-10 seconds.
Arm Title
Group 4 (rt-PA 0.9 mg/kg)
Arm Type
Active Comparator
Arm Description
10% of rt-PA 0.9 mg/kg administered as an initial IV bolus followed by the remaining 90% as an IV infusion over the next 1 hour.
Intervention Type
Drug
Intervention Name(s)
TNK-tPA
Other Intervention Name(s)
rtPA
Intervention Description
Experimental arms for low, middle, and high dosing; and active control arm for the standard protocol
Primary Outcome Measure Information:
Title
National Institutes of Health Stroke Scale (NIHSS)
Description
Proportion of subjects with NIHSS 1 or at least 4 on the NIHSS score decreased from the baseline at day14.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Modified Rankin Scale (mRS)
Description
Proportion of subjects of excellent outcome defined as mRS (0-1) at 90 days. Ordinal distribution of mRS and change of proportion of subjects with mRS (0-2) at 90 days.
Time Frame
90 days
Title
National Institutes of Health Stroke Scale (NIHSS)
Description
Neurological impairment defined as change of NIHSS score at 90 days.
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
EQ-5D
Description
Quality of life measured by EQ-5D scale.
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.
Time Frame
36 hours
Title
Death
Description
Overall mortality rate at 90 days.
Time Frame
90 days
Title
Asymptomatic intracranial hemorrhage
Description
Proportion of patients with asymptomatic intracranial hemorrhage at 90 days.
Time Frame
90 days
Title
Hemorrhage in other parts
Description
The proportion of patients with other bleeding events was defined by GUSTO bleeding at 90 days.
Time Frame
90 days
Title
AE/SAE
Description
Proportion of patients with adverse events / severe adverse events at 90 days.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age over 18 years. Time from onset to treatment < 3 hours; the time symptoms start is defined as "the last moment they appear normal". Diagnosis of ischemic stroke according to "2014 China Guideline for Diagnosis and Treatment of Acute Ischemic Stroke" with assessable neurological impairment e.g., language, motor function, cognitive impairment, gaze impairment, visual field deficit and/or visual neglect. Ischemic stroke is defined as sudden acute focal neurological impairment with suspected cerebral ischemia, hemorrhage ruled out by CT scan. mRS > 2 at the first onset or prior onset. Baseline NIHSS score is > 4 and < 26. Signed informed consent. Exclusion Criteria: Absolute contraindications: 1.1 History of severe head trauma or stroke within 3 months; 1.2 Suspected subarachnoid hemorrhage; 1.3 Arterial puncture at a non-compressible site within the previous 1week; 1.4 History of intracranial hemorrhage; 1.5 Intracranial tumor, vascular malformation, or arterial aneurysm; 1.6 Recent intracranial or intraspinal surgery; 1.7 Systolic blood pressure ≧ 180 mm Hg, or diastolic blood pressure ≧ 100 mm Hg; Increased blood pressure; 1.8 Active internal bleeding ; 1.9 Acute bleeding tendency, including platelet count below 100×109/L or otherwise; 1.10 Heparin treatment was performed within 48 h ( APTT exceeded the upper limit of normal range ) ; 1.11 Warfarin has been taken orally , and the international standardized ratio is INR > 1.7 or PT > 15 s ; 1.12 Anticoagulant drugs such as thrombin inhibitor or Xa factor inhibitor , argatroban ( including new anticoagulants with unclear mechanism ) are currently being used , and various sensitive laboratory tests are abnormal ( such as live ) APTT , INR , Platelet count , Serpentine ECT of pulse enzyme setting time ; thrombin time TT or appropriate determination of Xa factor activity ) ; 1.13 Blood glucose < 2.7 mmol/L; 1.14 CT showed multilobular infarction ( low density > 1 / 3 cerebral hemisphere ) Relative contraindications : The risks and benefits of thrombolysis should be carefully considered and weighed in the following cases ( that is , although there is one or more relative contraindications , it is not absolutely impossible to thrombolysis ). 2.1 Mild stroke or stroke with rapid improvement of symptoms; 2.2 Women in pregnancy ; 2.3 Symptoms of neurological impairment after seizures ; 2.4 There have been major surgical operations or serious injuries in the last 2 weeks; 2.5 There were gastrointestinal or urinary system bleeding in recent 3 weeks ; 2.6 History of myocardial infarction within 3 months. Have been enrolled in rhTNK-tPA in pre-study or participated in other clinical trials within 3 months prior to screening. Lactating women, or childbearing women who do not use effective contraception. Known allergy to rhTNK-tPA and/or rt-PA or relevant excipients. The researchers judged that not suitable to participate in this study or participate in this study may lead to greater risk for patients ; Can not comply with the test program or follow-up requirements .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meng Wang, MD,ph.D
Organizational Affiliation
IRB of Beijing Tiantan Hospital,Capital Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The Ninth People's Hospital of Chongqing
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
First Affiliated Hospital of Jinan University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
ShenZhen Hospital ,Beijing University
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
Affiliated Hosptial to GuiZhou Medical University
City
Guiyang
State/Province
Guizhou
Country
China
Facility Name
HaiNan Provincial People's Hospital
City
Haikou
State/Province
Hainan
Country
China
Facility Name
Hebei Medical University Third Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
Facility Name
Tangshan Workers' Hospital
City
Tangshan
State/Province
Hebei
Country
China
Facility Name
The First Hospital Of Qiqihar
City
Qiqihar
State/Province
Heilongjiang
Country
China
Facility Name
Luoyang First People's Hosptical
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471000
Country
China
Facility Name
1st Hospital Affiliated to Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
ChangSha 1st Municipal Hospital
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Baotou Central Hospital
City
Baotou
State/Province
Inner Mongolia
Country
China
Facility Name
Inner Mongolia BaoGang Hospital
City
Baotou
State/Province
Inner Mongolia
Country
China
Facility Name
Huai'an Second People's Hospital
City
Huai'an
State/Province
Jiangsu
Country
China
Facility Name
First Hospital of Jilin University
City
Chang chun
State/Province
Jilin
Country
China
Facility Name
Meihekou Central Hospital
City
Tonghua
State/Province
Jilin
ZIP/Postal Code
135000
Country
China
Facility Name
First People 's Hospital Of Shenyang
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
General Hospital of Northern War Zone , PLA
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Linyi People's Hospital
City
Linyi
State/Province
Shandong
Country
China
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
State/Province
Shandong
Country
China
Facility Name
HuaShan Hospital Affiliated to FuDan University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
ZhongShan Hospital ,FuDan University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
SiChuan University HuaXi Hospital
City
Chengdu
State/Province
Sichuan
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
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Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events(TRACE)

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