A Study in Chinese Patients to Compare How Tenecteplase and Alteplase Given After a Stroke Improve Recovering of Physical Activity
ORIGINAL
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
1 other identifier
interventional
1,489
1 country
55
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 stroke
Started Jun 2021
Shorter than P25 for phase_3 stroke
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2021
CompletedFirst Posted
Study publicly available on registry
June 7, 2021
CompletedStudy Start
First participant enrolled
June 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 8, 2023
CompletedResults Posted
Study results publicly available
December 10, 2024
CompletedDecember 10, 2024
December 1, 2024
2.3 years
June 4, 2021
October 7, 2024
December 6, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With 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). It was measured at Day 90. Percentages are rounded to the nearest digits.
At Day 90±7 days
Secondary Outcomes (8)
Percentage of Participants With Major Neurological Improvement (National Institutes of Health Stroke Scale (NIHSS) Score of 0 or Improvement of at Least 4 Points Compared With Baseline
At 24 hours
Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-2
At Day 90
Change From Baseline of National Institutes of Health Stroke Scale (NIHSS) Score
At baseline and at Day 90
Distribution of Modified Rankin Scale (mRS)
At Day 90
Percentage of Participants With Barthel Index Score ≥95
up to 90 days
- +3 more secondary outcomes
Study Arms (2)
Tenecteplase treatment group
EXPERIMENTALChinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of tenecteplase, 0.25 mg/kg via intravenous (iv) bolus no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patient performed a 90-day follow-up visit after the treatment to complete the study.
Alteplase active control group
ACTIVE COMPARATORChinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of alteplase, 0.9 mg/kg, 10% via intravenous (iv) bolus and the remaining 90% of the total dose administered as an iv infusion over 1 h no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patient performed a 90-day follow-up visit after the treatment to complete the study.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (55)
Inner Mongolia Baogang Hospital
Baotou, 14000, China
Beijing Chao-Yang Hospital
Beijing, 100020, China
Beijing Tsinghua Changgung Hospital
Beijing, 100044, China
Beijing Tiantan Hospital affiliated to Cap Med University
Beijing, 100070, China
Beijing Tongren Hospital
Beijing, 100730, China
The First Hospital of Jilin University
Changchun, 130031, China
The third xiangya hospital of Central South University
Changsha, 410013, China
Hexigten Banner Mongolian Traditional Chinese medicine hospital
Chifeng, 025350, China
Second Affiliated Hospital Chongqing Medical University
Chongqing, 400016, China
Center Hospital of Dalian
Dalian, 116021, China
Daqing People's Hospital
Daqing, 163000, China
Shengli Oilfield central hospital
Dongying, 257091, China
Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510150, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, 550004, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, 310009, China
Zhejiang Province People's Hospital
Hangzhou, 310014, China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, 310015, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, 310016, China
Huai'an Second People's Hospital
Huai'an, 223002, China
The First Affiliated Hospital of Baotou Medical College
Inner Mongolia, 014010, China
The second Hospital of Jiaxing
Jiaxing, 314001, China
Center Hospital of Jinan
Jinan, 250013, China
Jinhua Municipal Central Hospital
Jinhua, 321000, China
The first People's Hospital of Lianyungang
Lianyungang, 222002, China
Linfen Central Hospital
Linfen, 041000, China
Linyi People's Hospital
Linyi, 276000, China
The First People's Hospital of Tancheng County
Linyi, 276000, China
The First Affiliated Hospital of Nanchang University
Nanchang, 330006, China
Zhongda Hospital Southeast University
Nanjing, 210009, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, 210011, China
The First People's Hospital of Nanning
Nanning, 530000, China
The First People's Hospital of Nantong
Nantong, 226001, China
Ruian People's Hospital
Ruian, 325200, China
Tongren hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200051, China
Tongji Hospital, Tongji University
Shanghai, 200065, China
Shanghai East Hospital
Shanghai, 200120, China
Shanghai Seventh People's Hospital
Shanghai, 200137, China
Affiliated Central Hospital of Shenyang Medical College
Shenyang, 110000, China
The First People's Hospital of Shenyang
Shenyang, 110000, China
Peking University Shenzhen Hospital
Shenzhen, 518000, China
The Second Hospital of Hebei Medical University
Shijiazhuang, 050000, China
The Second Affiliated Hospital of Soochow University
Suzhou, 215004, China
Taizhou Hospital of Zhejiang Province
Taizhou, 317099, China
The 2nd Hospital of Tianjin Medical University
Tianjin, 300000, China
The First Center Hospital of Tianjin
Tianjin, 300192, China
Tianjin Medical University General Hospital
Tianjin, 30052, China
Wuhan Union Hospital
Wuhan, 430022, China
Wuxi People's Hospital
Wuxi, 214043, China
Xianyang Hospital of Yan'an University
Xianyang, 712000, China
Xinxiang Central Hospital
Xinxiang, 453000, China
The People's Hospital Of Xuancheng City
Xuancheng, 242000, China
Affiliated Hospital, Xuzhou Medical college
Xuzhou, 221006, China
Affiliated Hospital of Yangzhou University
Yangzhou, 225001, China
Yantai Yuhuangding Hospital
Yantai, 264010, China
Yiyang Central Hospital
Yiyang, 413000, China
Related Publications (2)
Meng X, Li S, Dai H, Lu G, Wang W, Che F, Geng Y, Sun M, Li X, Wang Y. Tenecteplase Versus Alteplase in Acute Ischemic Stroke in Chinese Patients: Protocol for the ORIGINAL Study. Stroke Vasc Interv Neurol. 2024 May 7;4(4):e001363. doi: 10.1161/SVIN.124.001363. eCollection 2024 Jul.
PMID: 41585404DERIVEDMeng X, Li S, Dai H, Lu G, Wang W, Che F, Geng Y, Sun M, Li X, Li H, Wang Y. Tenecteplase vs Alteplase for Patients With Acute Ischemic Stroke: The ORIGINAL Randomized Clinical Trial. JAMA. 2024 Nov 5;332(17):1437-1445. doi: 10.1001/jama.2024.14721.
PMID: 39264623DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2021
First Posted
June 7, 2021
Study Start
June 22, 2021
Primary Completion
October 8, 2023
Study Completion
October 8, 2023
Last Updated
December 10, 2024
Results First Posted
December 10, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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'.
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.