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ALTEPLASE-TENECTEPLASE TRIAL EVALUATION FOR STROKE THROMBOLYSIS (ATTEST 2)

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Abstract

Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis (ATTEST 2) Background and Aims Newer plasminogen activators have improved pharmacological characteristics (longer half-life, higher fibrin affinity, less disruption to endogenous haemostasis). Based on data from selected patients with large artery occlusion, and individual patient data meta-analysis, we hypothesise that tenecteplase will be superior to alteplase. Data from EXTEND-IA TNK provides further strong support for this hypothesis but was restricted to selected patients with large artery occlusion. Substantially more data are required to establish the true risk-benefit profile compared with alteplase in the general stroke population. Method ATTEST-2 will establish whether tenecteplase is superior to alteplase by undertaking a prospective randomised open blinded end-point (PROBE) trial in patients eligible for IV thrombolysis based on non-contrast CT imaging. Up to 60 UK centres will recruit 1870 patients. All UK regulatory approvals are in place. The ATTEST-2 study has been adopted onto the NIHR Clinical Research Network Portfolio. Study recruitment is ongoing and will continue until Feb 2020. Results Primary outcome is the distribution of modified Rankin Scale (mRS) outcomes at day 90, determined by the Rankin Focused Assessment method, analysed by ordinal distribution ("shift") analysis of the of scores in intervention and control groups. Conclusion An agent with superior risk:benefit ratio compared to alteplase would improve outcomes and may reduce the need for thrombectomy. Even for equivalent outcomes, superior ease of use of tenecteplase would confer significant clinical advantages.

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© Copyright 2019 Morressier GmbH. All rights reserved.

© Copyright 2019 Morressier GmbH.
All rights reserved.