TIMELESS

Trial ID or NCT#

NCT03785678

Status

not recruiting iconNOT RECRUITING

Purpose

This study will evaluate the efficacy and safety of tenecteplase compared with placebo in participants with acute ischemic stroke (AIS). All participants will receive standard-of-care therapy according to AmericanHeart Association/American Stroke Association clinical guidelines (2018). To determine eligibility for randomization, all participants will undergo multimodal CT or MRI at baseline. Only participants with a vessel occlusion (ICA or MCA M1/M2) and penumbral tissue will be randomized. The primary analysis is to compare the efficacy of tenecteplase versus placebo in all participants at Day 90.

Official Title

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)

Eligibility Criteria

Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
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Investigator(s)

Gregory W. Albers, MD
Gregory W. Albers, MD
Stroke and vascular neurologist
Coyote Foundation Professor and Professor, by courtesy, of Neurosurgery
Neil Schwartz
Neil Schwartz
Stroke and vascular neurologist, General neurologist
Clinical Professor, Adult Neurology Clinical Professor (By courtesy), Neurosurgery

View on ClinicalTrials.gov