Prospective Observational Cohort Study of Tenecteplase: Results From the Indian Registry in Ischemic Stroke‐Tenecteplase
Background Tenecteplase has been approved for acute ischemic stroke at a dose of 0.2 mg/kg by the Indian licensing authority. A registry to evaluate the safety of tenecteplase was mandated by the licensing authority. The research aim was to use the Indian Registry in Ischemic Stroke‐Tenecteplase (IR...
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2024-12-01
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| Series: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
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| Online Access: | https://www.ahajournals.org/doi/10.1161/JAHA.124.036382 |
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| author | Amit Saraf Percival C. Gilvaz Tirppur C. R. Ramakrishnan R. N. Komal Kumar Salvadeeswaran Meenakshi‐Sundaram Santosh M. Sontakke Anand Alurkar Somasundaram Kumaravelu Pamidimukkala Vijaya Mangesh Udar Deepak Arjundas Soaham Desai Mukesh Sharma Suresh BV Rithesh R. Nair Sadique Pathan Shripad S. Pujari Sudhir Kumar Keyur Machhavada Jayantee Kalita Usha K. Misra Bhalchandra Vaidya Leonid Churilov Mark W. Parsons Sanjay Singh |
| author_facet | Amit Saraf Percival C. Gilvaz Tirppur C. R. Ramakrishnan R. N. Komal Kumar Salvadeeswaran Meenakshi‐Sundaram Santosh M. Sontakke Anand Alurkar Somasundaram Kumaravelu Pamidimukkala Vijaya Mangesh Udar Deepak Arjundas Soaham Desai Mukesh Sharma Suresh BV Rithesh R. Nair Sadique Pathan Shripad S. Pujari Sudhir Kumar Keyur Machhavada Jayantee Kalita Usha K. Misra Bhalchandra Vaidya Leonid Churilov Mark W. Parsons Sanjay Singh |
| author_sort | Amit Saraf |
| collection | DOAJ |
| description | Background Tenecteplase has been approved for acute ischemic stroke at a dose of 0.2 mg/kg by the Indian licensing authority. A registry to evaluate the safety of tenecteplase was mandated by the licensing authority. The research aim was to use the Indian Registry in Ischemic Stroke‐Tenecteplase (IRIS‐TNK) to assess the safety and clinical outcomes in patients treated with tenecteplase in routine clinical practice. Methods and Results In this prospective, registry‐based observational, cohort study, the primary outcome was proportion of symptomatic intracerebral hemorrhages at 36±6 hours after treatment. Secondary outcomes included improvement in National Institutes of Health Stroke Scale (NIHSS) score by either ≥4 or 8 points or an NIHSS score of 0, assessment of excellent outcome (modified Rankin Scale score 0 or 1), functional independence (modified Rankin Scale score 0–2), and Barthel Index score. From October 2017 to May 2023, 1015 patients with a median age of 62 years (interquartile range [IQR, 52–71 years]) were recruited across India. The median baseline NIHSS score was 9 (IQR, 6–13). The proportion of patients with symptomatic intracerebral hemorrhage was 0.6% (95% CI, 0.2–1.3%), and 10 patients (1% [95% CI, 0.5–1.9%]) died within 3 months. Improvement in NIHSS score by ≥4 points or an NIHSS score of 0 at 24 hours was observed in 34.4% (95% CI, 31.5–37.4%) of patients. An excellent outcome (modified Rankin Scale score 0 or 1) at 3 months was achieved in 55.4% (95% CI, 52.3–58.5%) of patients. Conclusions These results confirm that tenecteplase at a dose of 0.2 mg/kg is safe in routine clinical practice, when administered within 4.5 hours of symptom onset. Registration https://ctri.nic.in/Clinicaltrials/. Identifier: CTRI/2017/11/010380. |
| format | Article |
| id | doaj-art-409d1f73084941ce8f623c71c15d1031 |
| institution | Kabale University |
| issn | 2047-9980 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| spelling | doaj-art-409d1f73084941ce8f623c71c15d10312024-12-03T10:06:25ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802024-12-01132310.1161/JAHA.124.036382Prospective Observational Cohort Study of Tenecteplase: Results From the Indian Registry in Ischemic Stroke‐TenecteplaseAmit Saraf0Percival C. Gilvaz1Tirppur C. R. Ramakrishnan2R. N. Komal Kumar3Salvadeeswaran Meenakshi‐Sundaram4Santosh M. Sontakke5Anand Alurkar6Somasundaram Kumaravelu7Pamidimukkala Vijaya8Mangesh Udar9Deepak Arjundas10Soaham Desai11Mukesh Sharma12Suresh BV13Rithesh R. Nair14Sadique Pathan15Shripad S. Pujari16Sudhir Kumar17Keyur Machhavada18Jayantee Kalita19Usha K. Misra20Bhalchandra Vaidya21Leonid Churilov22Mark W. Parsons23Sanjay Singh24Gennova Biopharmaceuticals Limited Pune Maharashtra IndiaDepartment of Neurology Jubilee Mission Medical College & Research Institute Thrissur Kerala IndiaDepartment of Neurology and Neurosurgery K.G. Hospital & Post Graduate Institute Coimbatore Tamil Nadu IndiaDepartment of Neurology Yashoda Hospitals Secunderabad Telengana IndiaApollo Speciality Hospitals Madurai Tamil Nadu IndiaRuby Hall Clinic Pune Maharashtra IndiaKEM Hospital Pune Maharashtra IndiaDr. Ramesh Cardiac & Multispeciality Hospital Pvt. Ltd. Guntur and Vijayawada Andhra Pradesh IndiaLalitha Super Specialities Hospital Pvt. Ltd. Guntur Andhra Pradesh IndiaSahyadri Hospitals Deccan Gymkhana Pune Maharashtra IndiaDepartment of Neurology Vijaya Hospital Chennai Tamil Nadu IndiaShree Krishna Hospital and Medical Research Centre Karamsad Gujarat IndiaApollo Hospitals Gandhinagar Ahmedabad Gujarat IndiaA.J. Institute of Medical Sciences & Research Centre Mangalore Karnataka IndiaSIMS Hospital Chennai Tamil Nadu IndiaSahyadri Hospitals Hadapsar Pune Maharashtra IndiaNoble Hospital Pune Maharashtra IndiaApollo Hospitals Jubilee Hills Hyderabad Telengana IndiaZydus Hospital Ahmedabad Gujarat IndiaDepartment of Neurology Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow Uttar Pradesh IndiaDepartment of Neurology Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow Uttar Pradesh IndiaGennova Biopharmaceuticals Limited Pune Maharashtra IndiaDepartment of Medicine, The Royal Melbourne Hospital The University of Melbourne Melbourne AustraliaDepartment of Neurology, Liverpool Hospital University of New South Wales Sydney New South Wales AustraliaGennova Biopharmaceuticals Limited Pune Maharashtra IndiaBackground Tenecteplase has been approved for acute ischemic stroke at a dose of 0.2 mg/kg by the Indian licensing authority. A registry to evaluate the safety of tenecteplase was mandated by the licensing authority. The research aim was to use the Indian Registry in Ischemic Stroke‐Tenecteplase (IRIS‐TNK) to assess the safety and clinical outcomes in patients treated with tenecteplase in routine clinical practice. Methods and Results In this prospective, registry‐based observational, cohort study, the primary outcome was proportion of symptomatic intracerebral hemorrhages at 36±6 hours after treatment. Secondary outcomes included improvement in National Institutes of Health Stroke Scale (NIHSS) score by either ≥4 or 8 points or an NIHSS score of 0, assessment of excellent outcome (modified Rankin Scale score 0 or 1), functional independence (modified Rankin Scale score 0–2), and Barthel Index score. From October 2017 to May 2023, 1015 patients with a median age of 62 years (interquartile range [IQR, 52–71 years]) were recruited across India. The median baseline NIHSS score was 9 (IQR, 6–13). The proportion of patients with symptomatic intracerebral hemorrhage was 0.6% (95% CI, 0.2–1.3%), and 10 patients (1% [95% CI, 0.5–1.9%]) died within 3 months. Improvement in NIHSS score by ≥4 points or an NIHSS score of 0 at 24 hours was observed in 34.4% (95% CI, 31.5–37.4%) of patients. An excellent outcome (modified Rankin Scale score 0 or 1) at 3 months was achieved in 55.4% (95% CI, 52.3–58.5%) of patients. Conclusions These results confirm that tenecteplase at a dose of 0.2 mg/kg is safe in routine clinical practice, when administered within 4.5 hours of symptom onset. Registration https://ctri.nic.in/Clinicaltrials/. Identifier: CTRI/2017/11/010380.https://www.ahajournals.org/doi/10.1161/JAHA.124.036382acute ischemic strokehemorrhagesstandard of caretenecteplasethrombolytic therapy |
| spellingShingle | Amit Saraf Percival C. Gilvaz Tirppur C. R. Ramakrishnan R. N. Komal Kumar Salvadeeswaran Meenakshi‐Sundaram Santosh M. Sontakke Anand Alurkar Somasundaram Kumaravelu Pamidimukkala Vijaya Mangesh Udar Deepak Arjundas Soaham Desai Mukesh Sharma Suresh BV Rithesh R. Nair Sadique Pathan Shripad S. Pujari Sudhir Kumar Keyur Machhavada Jayantee Kalita Usha K. Misra Bhalchandra Vaidya Leonid Churilov Mark W. Parsons Sanjay Singh Prospective Observational Cohort Study of Tenecteplase: Results From the Indian Registry in Ischemic Stroke‐Tenecteplase Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease acute ischemic stroke hemorrhages standard of care tenecteplase thrombolytic therapy |
| title | Prospective Observational Cohort Study of Tenecteplase: Results From the Indian Registry in Ischemic Stroke‐Tenecteplase |
| title_full | Prospective Observational Cohort Study of Tenecteplase: Results From the Indian Registry in Ischemic Stroke‐Tenecteplase |
| title_fullStr | Prospective Observational Cohort Study of Tenecteplase: Results From the Indian Registry in Ischemic Stroke‐Tenecteplase |
| title_full_unstemmed | Prospective Observational Cohort Study of Tenecteplase: Results From the Indian Registry in Ischemic Stroke‐Tenecteplase |
| title_short | Prospective Observational Cohort Study of Tenecteplase: Results From the Indian Registry in Ischemic Stroke‐Tenecteplase |
| title_sort | prospective observational cohort study of tenecteplase results from the indian registry in ischemic stroke tenecteplase |
| topic | acute ischemic stroke hemorrhages standard of care tenecteplase thrombolytic therapy |
| url | https://www.ahajournals.org/doi/10.1161/JAHA.124.036382 |
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