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A Phase III, Prospective, Double-Blind, Randomized, Placebo-Controlled Trial of Thrombolysis in Imaging-Eligible, Late-Window Patients to Assess the Efficacy and Safety of Tenecteplase (TIMELESS): Rationale and Design.

A Phase III, Prospective, Double-Blind, Randomized, Placebo-Controlled Trial of Thrombolysis in Imaging-Eligible, Late-Window Patients to Assess the Efficacy and Safety of Tenecteplase (TIMELESS): Rationale and Design. International journal of stroke : official journal of the International Stroke Society Albers, G. W., Campbell, B. C., Lansberg, M. G., Broderick, J., Butcher, K., Froehler, M. T., Schwamm, L. H., Nouh, A. M., Liebeskind, D. S., Toy, F., Yang, M., Massaro, L., Schoeffler, M., Purdon, B. 2022: 17474930221088400

Abstract

Rationale: While thrombolysis is standard of care for patients with acute ischemic stroke (AIS) within 4.5 hours of symptom onset, the benefit of tenecteplase beyond this time window is less certain.Aim: The TIMELESS trial (NCT03785678) aims to determine if treatment with tenecteplase increases the proportion of good clinical outcomes among patients with stroke due to a large vessel occlusion who present beyond 4.5 hours after symptom onset.Sample size estimates: A total of 456 patients will provide =90% power to detect differences in the distribution of modified Rankin Scale scores at Day 90 at the 2-sided 0.049 significance level.Methods and design: TIMELESS is a phase III, double-blind, randomized, placebo-controlled trial of tenecteplase with or without endovascular thrombectomy in patients with AIS and evidence of salvageable tissue via imaging who present within the 4.5-24-hour time window with an internal carotid artery (ICA) or middle cerebral artery (MCA) occlusion.Study outcomes: The primary efficacy objective of tenecteplase compared with placebo will be evaluated with ordinal modified Rankin Scale scores at Day 90. Safety will be evaluated via incidence of symptomatic intracranial hemorrhage, incidence and severity of adverse events and mortality rate.Discussion: Results from TIMELESS will contribute to understanding of the safety and efficacy of tenecteplase administered 4.5-24 hours following symptom onset for patients with an ICA or MCA occlusion.

View details for DOI 10.1177/17474930221088400

View details for PubMedID 35262424