Comment on: “Efficacy and Safety of Intravenous Tenecteplase Bolus in Acute Ischemic Stroke: Results of Two Open-Label, Multicenter Trials”
In a recent issue of the American Journal of Cardiovascular Drugs, Ramakrishnan et al.  published their research on the efficacy and safety of bolus intravenous tenecteplase (TNK-tPA) in patients with acute ischemic stroke (AIS) arriving within 3 h of symptom onset. The authors conducted two open-label studies enrolling a total of 112 patients with AIS arriving within 3 h of onset of symptoms. Study 1 was an open-label randomized dose-finding preliminary study enrolling 50 eligible patients in which an intravenous bolus of TNK-tPA 0.1 mg/kg (20 patients) or 0.2 mg/kg (30 patients) was administered. Study 2 was a single-arm, open-label study enrolling 62 eligible patients in which an intravenous bolus of TNK-tPA 0.2 mg/kg was administered. The primary endpoint of both studies was an improvement of ≥ 8 points or a score of 0 on the National Institutes of Health Stroke Scale (NIHSS) (major neurological improvement) at 24 h. However, in study 2, for comparison with...
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Conflicts of interest
Prashant Rana, Nilan Jacob, Tomson Toms, and Shraddha Bhure are employees of Boehringer Ingelheim India Pvt. Ltd., and have no additional conflicts of interest that might be relevant to the content of this letter.
- 10.Hill MD et al. A randomized controlled trial of TNK-tPA versus standard of care for minor ischemic stroke with proven occlusion (TEMPO-2). https://clinicaltrials.gov/ct2/show/NCT02398656. Accessed 27 Sep 2018.
- 11.Spratt N et al. Tenecteplase versus Alteplase for Stroke Thrombolysis Evaluation (TASTE) Trial. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363714&isReview=true. Accessed 27 Sep 2018.
- 12.Mathiesen EB et al. Tenecteplase in wake-up ischaemic stroke trial (TWIST). https://clinicaltrials.gov/ct2/show/NCT03181360. Accessed 27 Sep 2018.
- 13.Muir K et al. Alteplase–tenecteplase Trial Evaluation for Stroke Thrombolysis (ATTEST-2). https://clinicaltrials.gov/ct2/show/NCT02814409. Accessed 27 Sep 2018.
- 14.Campbell B, Sallaberger M et al. Determining the optimal dose of tenecteplase before endovascular therapy for ischaemic stroke (EXTEND-IA TNK Part 2). https://clinicaltrials.gov/ct2/show/NCT03340493. Accessed 27 Sep 2018.