Observational studyJournal of the American Heart Association2024
Prospective Observational Cohort Study of Tenecteplase: Results From the Indian Registry in Ischemic Stroke-Tenecteplase.
Observational study in Journal of the American Heart Association, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- Tenecteplase and other TNK formulations lose PAI-1 resistance in their 2-chain form: comparison with alteplase.Blood advances · 2026Article
- Safety assessment of tenecteplase for the treatment of acute myocardial infarction and ischemic stroke, and identification of key genes.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Incidence, Predictors, and Outcomes of Symptomatic Intracranial Hemorrhage after Tenecteplase in Acute Ischemic Stroke.Annals of Indian Academy of Neurology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
25 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTenecteplase 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
resultsIn 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.
conclusionsThese 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.
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