Prospective Observational Cohort Study of Tenecteplase: Results From the Indian Registry in Ischemic Stroke‐Tenecteplase

Abstract

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.

Keywords

• acute ischemic stroke
• hemorrhages
• standard of care
• tenecteplase
• thrombolytic therapy