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) (TIMELESS)
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.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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