Recruiting

Testing a clot-busting medication for certain strokes beyond the standard treatment window

Plain-English translation of NCT05199662 on ClinicalTrials.gov ↗ · Source last updated April 2025 · Translation generated July 2026 · How we translate trials

Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This study is testing whether a medication called Tenecteplase can help people who've had a specific type of stroke when given as an intravenous injection between 4.5 and 12 hours after the stroke began. The medication works by breaking up blood clots in smaller brain arteries. Researchers believe this treatment might help save brain tissue and improve outcomes for patients who miss the window for standard clot-busting therapy or surgery.

Most stroke patients can only receive clot-busting treatment within the first 4.5 hours, and some strokes affect smaller blood vessels that aren't candidates for surgery. This medication might offer a new option for patients in this gap period who have evidence that brain tissue can still be saved.

Do you qualify?

You likely qualify if…

you have had an acute ischemic stroke that began between 4.5 and 12 hours before you can be treated
your stroke affects smaller blood vessels (not the large ones that would require surgical intervention)
imaging shows that part of your brain can still be saved, meaning there is a mismatch between your symptoms and the actual damage
you are at least 18 years old with no upper age limit
you did not have significant disability before your stroke

You likely don't qualify if…

you were able to receive standard clot-busting medication within 4.5 hours of stroke onset
your stroke is caused by a blockage in a major brain artery that requires surgery
you woke up with stroke symptoms and do not have imaging evidence of a mismatch between symptoms and damage
you had significant disability or dependence in daily activities before your stroke

What participation looks like

You will be randomly assigned to receive either the medication or a placebo as a single injection into your vein over 5 seconds. Neither you nor your medical team will know which treatment you received. You will be followed for 90 days after treatment, during which doctors will assess your recovery and monitor for any side effects or complications.

AI-generated summary from trial data · Jul 4, 2026 · Not medical advice

Trial locations(15 sites)

Brazil

Hospital Moinhos de Vento, Porto Alegre, Rio Grande do Sul

Hospital das Clínicas Botucatu, Botucatu

Hospital das Clínicas - UNICAMP, Campinas

Hospital Universitário Maria Aparecida Pedrossian, Campo Grande

Hospital das Clínicas UFPR, Curitiba