A Study in Chinese Patients to Compare How Tenecteplase and Alteplase Given After a Stroke Improve Recovering of Physical Activity
NCT ID: NCT04915729
Last Updated: 2024-12-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1489 participants
INTERVENTIONAL
2021-06-22
2023-10-08
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Alteplase active control group
Chinese 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.
alteplase
alteplase
Tenecteplase treatment group
Chinese 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.
tenecteplase
tenecteplase
Interventions
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tenecteplase
tenecteplase
alteplase
alteplase
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Inner Mongolia Baogang Hospital
Baotou, , China
Beijing Chao-Yang Hospital
Beijing, , China
Beijing Tsinghua Changgung Hospital
Beijing, , China
Beijing Tiantan Hospital affiliated to Cap Med University
Beijing, , China
Beijing Tongren Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
The third xiangya hospital of Central South University
Changsha, , China
Hexigten Banner Mongolian Traditional Chinese medicine hospital
Chifeng, , China
Second Affiliated Hospital Chongqing Medical University
Chongqing, , China
Center Hospital of Dalian
Dalian, , China
Daqing People's Hospital
Daqing, , China
Shengli Oilfield central hospital
Dongying, , China
Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, , China
The Affiliated Hospital of Guizhou Medical University
Guiyang, , China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, , China
Zhejiang Province People's Hospital
Hangzhou, , China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, , China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, , China
Huai'an Second People's Hospital
Huai'an, , China
The First Affiliated Hospital of Baotou Medical College
Inner Mongolia, , China
The second Hospital of Jiaxing
Jiaxing, , China
Center Hospital of Jinan
Jinan, , China
Jinhua Municipal Central Hospital
Jinhua, , China
The first People's Hospital of Lianyungang
Lianyungang, , China
Linfen Central Hospital
Linfen, , China
Linyi People's Hospital
Linyi, , China
The First People's Hospital of Tancheng County
Linyi, , China
The First Affiliated Hospital of Nanchang University
Nanchang, , China
Zhongda Hospital Southeast University
Nanjing, , China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, , China
The First People's Hospital of Nanning
Nanning, , China
The First People's Hospital of Nantong
Nantong, , China
Ruian People's Hospital
Ruian, , China
Tongren hospital, Shanghai Jiaotong University School of Medicine
Shanghai, , China
Tongji Hospital, Tongji University
Shanghai, , China
Shanghai East Hospital
Shanghai, , China
Shanghai Seventh People's Hospital
Shanghai, , China
Affiliated Central Hospital of Shenyang Medical College
Shenyang, , China
The First People's Hospital of Shenyang
Shenyang, , China
Peking University Shenzhen Hospital
Shenzhen, , China
The Second Hospital of Hebei Medical University
Shijiazhuang, , China
The Second Affiliated Hospital of Soochow University
Suzhou, , China
Taizhou Hospital of Zhejiang Province
Taizhou, , China
The 2nd Hospital of Tianjin Medical University
Tianjin, , China
The First Center Hospital of Tianjin
Tianjin, , China
Tianjin Medical University General Hospital
Tianjin, , China
Wuhan Union Hospital
Wuhan, , China
Wuxi People's Hospital
Wuxi, , China
Xianyang Hospital of Yan'an University
Xianyang, , China
Xinxiang Central Hospital
Xinxiang, , China
The People's Hospital Of Xuancheng City
Xuancheng, , China
Affiliated Hospital, Xuzhou Medical college
Xuzhou, , China
Affiliated Hospital of Yangzhou University
Yangzhou, , China
Yantai Yuhuangding Hospital
Yantai, , China
Yiyang Central Hospital
Yiyang, , China
Countries
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References
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Meng 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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1123-0040
Identifier Type: -
Identifier Source: org_study_id