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A Study in Chinese Patients to Compare How Tenecteplase and Alteplase Given After a Stroke Improve Recovering of Physical Activity (ORIGINAL)

Primary Purpose

Stroke

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
tenecteplase
alteplase
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥18 years old
  • Diagnosis of ischaemic stroke with a measurable neurological deficit on National Institutes of Health Stroke Scale (NIHSS) (0< NIHSS ≤25); if NIHSS <4, patients have to be with at least a measurable deficit on motor power (upper or lower limbs ≥1)
  • Stroke symptoms should have been present for at least 30 minutes (min) without significant improvement prior to randomisation
  • Thrombolytic therapy can be initiated within 4.5 Hour(s) (h) of Acute ischaemic stroke (AIS) onset
  • Patients with premorbid modified Rankin Scale (mRS) 0 or 1
  • Signed and dated written informed consent in accordance with good clinical practice (GCP) and local legislation prior to trial admission

Exclusion Criteria:

  • Evidence of intracranial haemorrhage on the Computed tomography (CT) scan or symptoms suggestive of subarachnoid haemorrhage, even if the CT scan is normal
  • Patients who must or are expected to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial

  • Acute bleeding diathesis, including but not limited to

    • Known genetic predisposition to bleeding or significant bleeding disorder at present or within the past 6 Month(s) (m)
    • Administration of heparin within the previous 48 h and activated partial thromboplastin time (aPTT) exceeding the upper limit of normal for laboratory measurement
    • Current use of vitamin K based oral anticoagulants (e.g. warfarin) and a prolonged prothrombin time (International normalised Ratio (INR) > 1.7 or Prothrombin time (PT)>15 seconds (s)) or current use of novel oral anticoagulants (i.e. dabigitran, rivaroxiban, or apixiban) with prolongation of activated partial thromboplastin time (aPTT) and/or PT above the upper limit of the local laboratory reference range
    • Platelet count of below 100,000/mm3 at screening
    • Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
    • Recent traumatic external heart massage, obstetrical delivery, or recent puncture of a non-compressive blood-vessel (e.g. subclavian or jugular vein puncture) , within the past 10 days
    • Known history of suspected intracranial haemorrhage or suspected subarachnoid haemorrhage from aneurysm
    • Neoplasm with increased haemorrhagic risk
    • Documented ulcerative gastrointestinal disease during the last 3 m, oesophageal varices, arterial aneurysm, or arterial/venous malformations
    • Any known disorder associated with a significant increased risk of bleeding
  • Bacterial endocarditis or pericarditis at screening
  • Acute pancreatitis at screening
  • Significant trauma or major surgery (according to the investigator's assessment) in the past 3 m
  • Imaging demonstrates multi-lobar infarction (hypodensity >1/3 cerebral hemisphere)
  • Severe uncontrolled arterial hypertension, e.g. systolic blood pressure (BP) >185 mmHg or diastolic BP >110 mmHg Further exclusion criteria apply.

Sites / Locations

  • Inner Mongolia Baogang Hospital
  • Beijing Chao-Yang Hospital
  • Beijing Tsinghua Changgung Hospital
  • Beijing Tiantan Hospital affiliated to Cap Med University
  • Beijing Tongren Hospital
  • The First Hospital of Jilin University
  • The third xiangya hospital of Central South University
  • Hexigten Banner Mongolian Traditional Chinese medicine hospital
  • Second Affiliated Hospital Chongqing Medical University
  • Center Hospital of Dalian
  • Daqing People's Hospital
  • Shengli Oilfield central hospital
  • Third Affiliated Hospital of Guangzhou Medical University
  • The Affiliated Hospital of Guizhou Medical University
  • The Second Affiliated Hospital of Nanjing Medical University
  • The Second Affiliated Hospital Zhejiang University School of Medicine
  • Zhejiang Province People's Hospital
  • The Affiliated Hospital of Hangzhou Normal University
  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
  • Huai'an Second People's Hospital
  • The First Affiliated Hospital of Baotou Medical College
  • The second Hospital of Jiaxing
  • Center Hospital of Jinan
  • Jinhua Municipal Central Hospital
  • The first People's Hospital of Lianyungang
  • Linfen Central Hospital
  • Taizhou Hospital of Zhejiang Province
  • Linyi People's Hospital
  • The First People's Hospital of Tancheng County
  • The First Affiliated Hospital of Nanchang University
  • Zhongda Hospital Southeast University
  • The First People's Hospital of Nanning
  • The First People's Hospital of Nantong
  • Ruian People's Hospital
  • Tongren hospital, Shanghai Jiaotong University School of Medicine
  • Tongji Hospital, Tongji University
  • Shanghai East Hospital
  • Shanghai Seventh People's Hospital
  • Affiliated Central Hospital of Shenyang Medical College
  • The First People's Hospital of Shenyang
  • Peking University Shenzhen Hospital
  • The Second Hospital of Hebei Medical University
  • The Second Affiliated Hospital of Soochow University
  • The 2nd Hospital of Tianjin Medical University
  • The First Center Hospital of Tianjin
  • Tianjin Medical University General Hospital
  • Wuhan Union Hospital
  • Wuxi People's Hospital
  • Xianyang Hospital of Yan'an University
  • Xinxiang Central Hospital
  • The People's Hospital Of Xuancheng City
  • Affiliated Hospital, Xuzhou Medical college
  • Affiliated Hospital of Yangzhou University
  • Yantai Yuhuangding Hospital
  • Yiyang Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

tenecteplase

alteplase

Arm Description

Treatment Group

Active control group

Outcomes

Primary Outcome Measures

Modified Rankin Scale (mRS) score of 0 or 1
Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death).

Secondary Outcome Measures

Major neurological improvement (National Institutes of Health Stroke Scale (NIHSS) score of 0 or improvement of at least 4 points compared with baseline)
National Institutes of Health Stroke Scale (NIHSS) is a 11-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 6 grades with 0 as normal, and there is an allowance for untestable items.
Modified Rankin Scale (mRS) score of 0-2
Change from baseline of National Institutes of Health Stroke Scale (NIHSS) score
Distribution of Modified Rankin Scale (mRS)
Barthel Index score ≥95
The Barthel Index is an ordinal scale used to measure performance in activities of daily living (ADL). The Barthel Index consists of 10 items. The total score of the Barthel Index ranges from 0 to 100, and higher scores indicate better outcome.
Symptomatic Intracerebral Haemorrhage (sICH) per European Cooperative Acute Stroke Study (ECASS) Ⅲ definition during on-treatment period
90-day mortality
Modified Rankin Scale (mRS) score of 5 or 6

Full Information

First Posted
June 4, 2021
Last Updated
October 17, 2023
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT04915729
Brief Title
A Study in Chinese Patients to Compare How Tenecteplase and Alteplase Given After a Stroke Improve Recovering of Physical Activity
Acronym
ORIGINAL
Official Title
A Phase III Multi-centre, Prospective, Randomised, Open Label, Blinded Endpoint (PROBE), Active-controlled Parallel Group Trial to Assess Efficacy and Safety of Tenecteplase Versus Alteplase in Chinese Patients With Acute Ischaemic Stroke Within 4.5 Hours After Stroke Onset
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 22, 2021 (Actual)
Primary Completion Date
October 8, 2023 (Actual)
Study Completion Date
October 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

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
This study is open to Chinese adults who had an ischaemic stroke, which means that blood vessels in the brain are blocked. To resolve blood clots, people in the study get either tenecteplase or alteplase within 4 hours and 30 minutes after stroke. The purpose of this study is to compare how tenecteplase and alteplase improve peoples' recovering of physical activity. Alteplase is standard of care. Tenecteplase is a modified variant of alteplase that is easier to administer and is approved to treat heart attack. This study is to find out whether tenecteplase is as good as alteplase in people with ischaemic stroke. Participants are equally put into 2 treatment groups by chance. Participants in one group get tenecteplase as a single injection into a vein. Participants in the other group get alteplase as an injection into a vein (10% of the dose) and the remainder as an infusion over 1 hour. Participants are in the study for about 3 months. They are in the hospital for the first week after treatment. Then they visit the study site 1 and 3 months after treatment. At these visits, peoples' ability to independently carry out daily activities is assessed. Scores for physical activity are compared between both treatment groups. The doctors also regularly check the general health of the participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1490 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tenecteplase
Arm Type
Experimental
Arm Description
Treatment Group
Arm Title
alteplase
Arm Type
Active Comparator
Arm Description
Active control group
Intervention Type
Drug
Intervention Name(s)
tenecteplase
Intervention Description
tenecteplase
Intervention Type
Drug
Intervention Name(s)
alteplase
Intervention Description
alteplase
Primary Outcome Measure Information:
Title
Modified Rankin Scale (mRS) score of 0 or 1
Description
Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death).
Time Frame
up to 90 days
Secondary Outcome Measure Information:
Title
Major neurological improvement (National Institutes of Health Stroke Scale (NIHSS) score of 0 or improvement of at least 4 points compared with baseline)
Description
National Institutes of Health Stroke Scale (NIHSS) is a 11-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 6 grades with 0 as normal, and there is an allowance for untestable items.
Time Frame
up to 24 hours
Title
Modified Rankin Scale (mRS) score of 0-2
Time Frame
up to 90 days
Title
Change from baseline of National Institutes of Health Stroke Scale (NIHSS) score
Time Frame
up to 90 days
Title
Distribution of Modified Rankin Scale (mRS)
Time Frame
up to 90 days
Title
Barthel Index score ≥95
Description
The Barthel Index is an ordinal scale used to measure performance in activities of daily living (ADL). The Barthel Index consists of 10 items. The total score of the Barthel Index ranges from 0 to 100, and higher scores indicate better outcome.
Time Frame
up to 90 days
Title
Symptomatic Intracerebral Haemorrhage (sICH) per European Cooperative Acute Stroke Study (ECASS) Ⅲ definition during on-treatment period
Time Frame
up to 36 hours
Title
90-day mortality
Time Frame
up to 90 days
Title
Modified Rankin Scale (mRS) score of 5 or 6
Time Frame
up to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years old Diagnosis of ischaemic stroke with a measurable neurological deficit on National Institutes of Health Stroke Scale (NIHSS) (0< NIHSS ≤25); if NIHSS <4, patients have to be with at least a measurable deficit on motor power (upper or lower limbs ≥1) Stroke symptoms should have been present for at least 30 minutes (min) without significant improvement prior to randomisation Thrombolytic therapy can be initiated within 4.5 Hour(s) (h) of Acute ischaemic stroke (AIS) onset Patients with premorbid modified Rankin Scale (mRS) 0 or 1 Signed and dated written informed consent in accordance with good clinical practice (GCP) and local legislation prior to trial admission Exclusion Criteria: Evidence of intracranial haemorrhage on the Computed tomography (CT) scan or symptoms suggestive of subarachnoid haemorrhage, even if the CT scan is normal Patients who must or are expected to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial Acute bleeding diathesis, including but not limited to Known genetic predisposition to bleeding or significant bleeding disorder at present or within the past 6 Month(s) (m) Administration of heparin within the previous 48 h and activated partial thromboplastin time (aPTT) exceeding the upper limit of normal for laboratory measurement Current use of vitamin K based oral anticoagulants (e.g. warfarin) and a prolonged prothrombin time (International normalised Ratio (INR) > 1.7 or Prothrombin time (PT)>15 seconds (s)) or current use of novel oral anticoagulants (i.e. dabigitran, rivaroxiban, or apixiban) with prolongation of activated partial thromboplastin time (aPTT) and/or PT above the upper limit of the local laboratory reference range Platelet count of below 100,000/mm3 at screening Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) Recent traumatic external heart massage, obstetrical delivery, or recent puncture of a non-compressive blood-vessel (e.g. subclavian or jugular vein puncture) , within the past 10 days Known history of suspected intracranial haemorrhage or suspected subarachnoid haemorrhage from aneurysm Neoplasm with increased haemorrhagic risk Documented ulcerative gastrointestinal disease during the last 3 m, oesophageal varices, arterial aneurysm, or arterial/venous malformations Any known disorder associated with a significant increased risk of bleeding Bacterial endocarditis or pericarditis at screening Acute pancreatitis at screening Significant trauma or major surgery (according to the investigator's assessment) in the past 3 m Imaging demonstrates multi-lobar infarction (hypodensity >1/3 cerebral hemisphere) Severe uncontrolled arterial hypertension, e.g. systolic blood pressure (BP) >185 mmHg or diastolic BP >110 mmHg Further exclusion criteria apply.
Facility Information:
Facility Name
Inner Mongolia Baogang Hospital
City
Baotou
ZIP/Postal Code
14000
Country
China
Facility Name
Beijing Chao-Yang Hospital
City
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Beijing Tsinghua Changgung Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Beijing Tiantan Hospital affiliated to Cap Med University
City
Beijing
ZIP/Postal Code
100070
Country
China
Facility Name
Beijing Tongren Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130031
Country
China
Facility Name
The third xiangya hospital of Central South University
City
Changsha
ZIP/Postal Code
410013
Country
China
Facility Name
Hexigten Banner Mongolian Traditional Chinese medicine hospital
City
Chifeng
ZIP/Postal Code
025350
Country
China
Facility Name
Second Affiliated Hospital Chongqing Medical University
City
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Name
Center Hospital of Dalian
City
Dalian
ZIP/Postal Code
116021
Country
China
Facility Name
Daqing People's Hospital
City
Daqing
ZIP/Postal Code
163000
Country
China
Facility Name
Shengli Oilfield central hospital
City
Dongying
ZIP/Postal Code
257091
Country
China
Facility Name
Third Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510150
Country
China
Facility Name
The Affiliated Hospital of Guizhou Medical University
City
Guiyang
ZIP/Postal Code
550004
Country
China
Facility Name
The Second Affiliated Hospital of Nanjing Medical University
City
Hangzhou
ZIP/Postal Code
210011
Country
China
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Facility Name
Zhejiang Province People's Hospital
City
Hangzhou
ZIP/Postal Code
310014
Country
China
Facility Name
The Affiliated Hospital of Hangzhou Normal University
City
Hangzhou
ZIP/Postal Code
310015
Country
China
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Facility Name
Huai'an Second People's Hospital
City
Huai'an
ZIP/Postal Code
223002
Country
China
Facility Name
The First Affiliated Hospital of Baotou Medical College
City
Inner Mongolia
ZIP/Postal Code
014010
Country
China
Facility Name
The second Hospital of Jiaxing
City
Jiaxing
ZIP/Postal Code
314001
Country
China
Facility Name
Center Hospital of Jinan
City
Jinan
ZIP/Postal Code
250013
Country
China
Facility Name
Jinhua Municipal Central Hospital
City
Jinhua
ZIP/Postal Code
321000
Country
China
Facility Name
The first People's Hospital of Lianyungang
City
Lianyungang
ZIP/Postal Code
222002
Country
China
Facility Name
Linfen Central Hospital
City
Linfen
ZIP/Postal Code
041000
Country
China
Facility Name
Taizhou Hospital of Zhejiang Province
City
Linhai
ZIP/Postal Code
317000
Country
China
Facility Name
Linyi People's Hospital
City
Linyi
ZIP/Postal Code
276000
Country
China
Facility Name
The First People's Hospital of Tancheng County
City
Linyi
ZIP/Postal Code
276000
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
ZIP/Postal Code
330006
Country
China
Facility Name
Zhongda Hospital Southeast University
City
Nanjing
ZIP/Postal Code
210009
Country
China
Facility Name
The First People's Hospital of Nanning
City
Nanning
ZIP/Postal Code
530000
Country
China
Facility Name
The First People's Hospital of Nantong
City
Nantong
ZIP/Postal Code
226001
Country
China
Facility Name
Ruian People's Hospital
City
Ruian
ZIP/Postal Code
325200
Country
China
Facility Name
Tongren hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
ZIP/Postal Code
200051
Country
China
Facility Name
Tongji Hospital, Tongji University
City
Shanghai
ZIP/Postal Code
200065
Country
China
Facility Name
Shanghai East Hospital
City
Shanghai
ZIP/Postal Code
200120
Country
China
Facility Name
Shanghai Seventh People's Hospital
City
Shanghai
ZIP/Postal Code
200137
Country
China
Facility Name
Affiliated Central Hospital of Shenyang Medical College
City
Shenyang
ZIP/Postal Code
110000
Country
China
Facility Name
The First People's Hospital of Shenyang
City
Shenyang
ZIP/Postal Code
110000
Country
China
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
ZIP/Postal Code
518000
Country
China
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
ZIP/Postal Code
050000
Country
China
Facility Name
The Second Affiliated Hospital of Soochow University
City
Suzhou City
ZIP/Postal Code
215004
Country
China
Facility Name
The 2nd Hospital of Tianjin Medical University
City
Tianjin
ZIP/Postal Code
300000
Country
China
Facility Name
The First Center Hospital of Tianjin
City
Tianjin
ZIP/Postal Code
300192
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
30052
Country
China
Facility Name
Wuhan Union Hospital
City
Wuhan
ZIP/Postal Code
430022
Country
China
Facility Name
Wuxi People's Hospital
City
Wuxi
ZIP/Postal Code
214043
Country
China
Facility Name
Xianyang Hospital of Yan'an University
City
Xianyang
ZIP/Postal Code
712000
Country
China
Facility Name
Xinxiang Central Hospital
City
Xinxiang
ZIP/Postal Code
453000
Country
China
Facility Name
The People's Hospital Of Xuancheng City
City
Xuancheng
ZIP/Postal Code
242000
Country
China
Facility Name
Affiliated Hospital, Xuzhou Medical college
City
Xuzhou
ZIP/Postal Code
221003
Country
China
Facility Name
Affiliated Hospital of Yangzhou University
City
Yangzhou
ZIP/Postal Code
225001
Country
China
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
ZIP/Postal Code
264010
Country
China
Facility Name
Yiyang Central Hospital
City
Yiyang
ZIP/Postal Code
413000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
IPD Sharing Time Frame
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD Sharing Access Criteria
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
IPD Sharing URL
https://www.mystudywindow.com/msw/datasharing
Links:
URL
http://www.mystudywindow.com
Description
Related Info

Learn more about this trial

A Study in Chinese Patients to Compare How Tenecteplase and Alteplase Given After a Stroke Improve Recovering of Physical Activity

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