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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenecteplase treatment group | Experimental | 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. |
|
| Alteplase active control group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tenecteplase | Drug | tenecteplase |
| |
| alteplase |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Total NIHSS score (0-42) = sum of 11 individual item scores, higher total scores meaning more severe deficits. indivudal domains: level of consciousness (LOC), best gaze, visual fields, facial paresis, motor function arms, motor function legs, limb ataxia, sensory, language, dysarthria, extinction and inattention. Mild strokes (NIHSS < 6): High likelihood of good recovery and independence, Moderate strokes (NIHSS 6-15): Variable outcomes depending on timely intervention, Severe strokes (NIHSS > 15): Lower likelihood of recovery without significant disability and higher risk of mortality. Percentages are rounded to the nearest digits. |
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Inclusion Criteria:
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
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inner Mongolia Baogang Hospital | Baotou | 14000 | China | |||
| Beijing Chao-Yang Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41585404 | Derived | 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. | |
| 39264623 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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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.
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.
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'.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
The main objective of this multi-centre, prospective, randomised, open label, blinded endpoint (PROBE), active-controlled parallel group phase III trial was to assess whether tenecteplase was non-inferior to alteplase in favourable outcome in Chinese patients with acute ischaemic stroke (AIS) who were eligible for intravenous (i.v.) thrombolysis within 4.5 h of symptom onset.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 patients performed a 90-day follow-up visit after the treatment to complete the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 23, 2023 | Sep 24, 2024 |
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| Drug |
alteplase |
|
| At 24 hours |
| Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-2 | Percentage of participants with Modified Rankin Scale (mRS) score of 0-2 is presented. 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 |
| Change From Baseline of National Institutes of Health Stroke Scale (NIHSS) Score | Total NIHSS score (0-42) = sum of 11 individual item scores, higher total scores meaning more severe deficits. indivudal domains: level of consciousness (LOC), best gaze, visual fields, facial paresis, motor function arms, motor function legs, limb ataxia, sensory, language, dysarthria, extinction and inattention. Restricted maximum likelihood (REML) based MMRM approach used to compare change from baseline in NIHSS score at day 90. If patient misses visit, missing data will not be imputed. The mixed effect model will handle missing data based on a likelihood method under MAR assumption. Change in NIHSS score from baseline = overall mean + treatment + visit + baseline NIHSS + age + time to drug administration since onset of stroke symptoms + treatment by visit interaction + baseline NIHSS by visit interaction + random error. | At baseline and at Day 90 |
| Distribution of Modified Rankin Scale (mRS) | Distribution of Modified Rankin Scale (mRS) is presented. 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. | At Day 90 |
| Percentage of Participants With 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. Percentages are rounded to the nearest digits. | up to 90 days |
| Percentage of Participants With Symptomatic Intracerebral Haemorrhage (sICH) Per European Cooperative Acute Stroke Study (ECASS) â…¢ Definition During On-treatment Period | Percentage of participants with Symptomatic Intracerebral Haemorrhage (sICH) per European Cooperative Acute Stroke Study (ECASS) â…¢ definition during on-treatment period is presented. Percentages are rounded to the nearest digits. | Up to 7 days. |
| Percentage of Participants Who Died by Day 90 | Percentage of participants who died by day 90 is presented. Percentages are rounded to the nearest digits. | up to 90 days |
| Percentage of Participants With Modified Rankin Scale (mRS) Score of 5 or 6 | Percentage of participants with Modified Rankin Scale (mRS) score of 5 or 6 is presented. 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 |
| 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 |
| FG001 | 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 patients performed a 90-day follow-up visit after the treatment to complete the study. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set (FAS): This patient set included all randomised patients who received any dose of treatment. Treatment assignment was as randomised. This was the primary analysis set for presentation of efficacy according to the intention-to-treat principle.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 patients performed a 90-day follow-up visit after the treatment to complete the study. |
| BG001 | 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 patients performed a 90-day follow-up visit after the treatment to complete the study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| National Institutes of Health Stroke Scale (NIHSS) class 1 at baseline | Total NIHSS score (0-42) = sum of 11 individual item scores, higher total scores meaning more severe deficits. individual domains: level of consciousness (LOC), best gaze, visual fields, facial paresis, motor function arms, motor function legs, limb ataxia, sensory, language, dysarthria, extinction and inattention. Mild strokes (NIHSS < 6): High likelihood of good recovery and independence, Moderate strokes (NIHSS 6-15): Variable outcomes depending on timely intervention, Severe strokes (NIHSS > 15): Lower likelihood of recovery without significant disability and higher risk of mortality. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full Analysis Set (FAS): This patient set included all randomised patients who received any dose of treatment. Treatment assignment was as randomised. This was the primary analysis set for presentation of efficacy according to the intention-to-treat principle. | Posted | Number | Percentage of participants | At Day 90±7 days |
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| Secondary | 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 | Total NIHSS score (0-42) = sum of 11 individual item scores, higher total scores meaning more severe deficits. indivudal domains: level of consciousness (LOC), best gaze, visual fields, facial paresis, motor function arms, motor function legs, limb ataxia, sensory, language, dysarthria, extinction and inattention. Mild strokes (NIHSS < 6): High likelihood of good recovery and independence, Moderate strokes (NIHSS 6-15): Variable outcomes depending on timely intervention, Severe strokes (NIHSS > 15): Lower likelihood of recovery without significant disability and higher risk of mortality. Percentages are rounded to the nearest digits. | Full Analysis Set (FAS), This endpoint analysis is based on observed cases, no imputation performed for patients missing NIHSS score at 24h. | Posted | Number | Percentage of participants | At 24 hours |
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| Secondary | Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-2 | Percentage of participants with Modified Rankin Scale (mRS) score of 0-2 is presented. 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. | Full Analysis Set (FAS): This patient set included all randomised patients who received any dose of treatment. Treatment assignment was as randomised. This was the primary analysis set for presentation of efficacy according to the intention-to-treat principle. | Posted | Number | Percentage of participants | At Day 90 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline of National Institutes of Health Stroke Scale (NIHSS) Score | Total NIHSS score (0-42) = sum of 11 individual item scores, higher total scores meaning more severe deficits. indivudal domains: level of consciousness (LOC), best gaze, visual fields, facial paresis, motor function arms, motor function legs, limb ataxia, sensory, language, dysarthria, extinction and inattention. Restricted maximum likelihood (REML) based MMRM approach used to compare change from baseline in NIHSS score at day 90. If patient misses visit, missing data will not be imputed. The mixed effect model will handle missing data based on a likelihood method under MAR assumption. Change in NIHSS score from baseline = overall mean + treatment + visit + baseline NIHSS + age + time to drug administration since onset of stroke symptoms + treatment by visit interaction + baseline NIHSS by visit interaction + random error. | Full Analysis Set (FAS): This patient set included all randomised patients who received any dose of treatment. Treatment assignment was as randomised. This was the primary analysis set for presentation of efficacy according to the intention-to-treat principle. | Posted | Least Squares Mean | Standard Error | score on a scale | At baseline and at Day 90 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Distribution of Modified Rankin Scale (mRS) | Distribution of Modified Rankin Scale (mRS) is presented. 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. | Full Analysis Set (FAS): This patient set included all randomised patients who received any dose of treatment. Treatment assignment was as randomised. This was the primary analysis set for presentation of efficacy according to the intention-to-treat principle. | Posted | Number | Percentage of participants | At Day 90 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With 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. Percentages are rounded to the nearest digits. | Full Analysis Set (FAS), No imputation was performed on patients missing Bathel Score at day 90. | Posted | Number | Percentage of participants | up to 90 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Symptomatic Intracerebral Haemorrhage (sICH) Per European Cooperative Acute Stroke Study (ECASS) â…¢ Definition During On-treatment Period | Percentage of participants with Symptomatic Intracerebral Haemorrhage (sICH) per European Cooperative Acute Stroke Study (ECASS) â…¢ definition during on-treatment period is presented. Percentages are rounded to the nearest digits. | Safety set (SS): This patient set included all patients who were randomised and received any dose of treatment. It was the main analysis set for presentation of safety. Patients were analysed according to the actual treatment. | Posted | Number | Percentage of participants | Up to 7 days. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Died by Day 90 | Percentage of participants who died by day 90 is presented. Percentages are rounded to the nearest digits. | Safety set (SS): This patient set included all patients who were randomised and received any dose of treatment. It was the main analysis set for presentation of safety. Patients were analysed according to the actual treatment. | Posted | Number | Percentage of participants | up to 90 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Modified Rankin Scale (mRS) Score of 5 or 6 | Percentage of participants with Modified Rankin Scale (mRS) score of 5 or 6 is presented. 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. | Full Analysis Set (FAS): This patient set included all randomised patients who received any dose of treatment. Treatment assignment was as randomised. This was the primary analysis set for presentation of efficacy according to the intention-to-treat principle. | Posted | Number | Percentage of participants | At Day 90 |
|
AEs are reported for the on-treatment period from start of treatment until end of residual effect period, up to 7 days. All cause mortality was reported from start of treatment until death by any cause, up to 97 days.
Safety set (SS): This patient set included all patients who were randomised and received any dose of treatment. It was the main analysis set for presentation of safety. Patients were analysed according to the actual treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 patients performed a 90-day follow-up visit after the treatment to complete the study. | 44 | 736 | 115 | 736 | 347 | 736 |
| EG001 | 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 patients performed a 90-day follow-up visit after the treatment to complete the study. | 34 | 732 | 116 | 732 | 334 | 732 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute left ventricular failure | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac dysfunction | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myocardial injury | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Stress ulcer haemorrhage | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperpyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Intracranial infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Brain contusion | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Brain herniation | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Spleen contusion | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute disseminated encephalomyelitis | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Basal ganglia haemorrhage | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Brain stem haemorrhage | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Carotid artery aneurysm | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Carotid artery dissection | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Carotid artery occlusion | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Carotid artery thrombosis | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebellar haemorrhage | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebral artery occlusion | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebral haematoma | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebral thrombosis | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Decorticate posture | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemorrhagic cerebral infarction | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemorrhagic transformation stroke | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Intraventricular haemorrhage | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Stroke in evolution | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thalamus haemorrhage | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombotic stroke | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arterial stenosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Embolism venous | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemorrhagic infarction | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperhomocysteinaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 6, 2023 | Sep 24, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077785 | Tenecteplase |
| D010959 | Tissue Plasminogen Activator |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| NIHSS total score 6 - 15 |
|
| NIHSS total score >=15 |
|
| OG001 | 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 patients performed a 90-day follow-up visit after the treatment to complete the study. |
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| OG001 | 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 patients performed a 90-day follow-up visit after the treatment to complete the study. |
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