Recruiting

Testing a new stroke treatment combined with standard clot-busting therapy

Plain-English translation of NCT06660719 on ClinicalTrials.gov ↗ · Source last updated March 2025 · Translation generated June 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 otaplimastat, given together with standard stroke treatment, can help reduce brain damage after an acute ischemic stroke. In animal studies, this medication showed promise in protecting brain tissue and working well with clot-busting drugs like tPA. The trial will compare the medication to a placebo in about 850 patients to see if it's truly effective and safe.

When someone has an ischemic stroke, clot-busting medications like tPA can help restore blood flow to the brain, but this process itself can sometimes cause additional damage to brain tissue. This medication is designed to protect the brain during and after this treatment, potentially reducing the overall amount of brain damage and improving recovery.

Do you qualify?

You likely qualify if…

you are between 19 and 85 years old
you have had an acute ischemic stroke with moderate to severe neurological symptoms
you were living independently before your stroke (able to do all your usual activities)
you can receive standard clot-busting therapy within 4.5 hours of your stroke symptoms starting
you are able and willing to undergo brain imaging scans (MRI)

You likely don't qualify if…

you have a known allergy or severe sensitivity to medications
you have had a heart attack in the last 6 months or have a serious heart rhythm problem
you have severe heart failure or certain types of lung disease that have needed recent treatment
you are pregnant, breastfeeding, or unwilling to use reliable contraception for 3 months
you have recently had cancer or are currently being treated for cancer

What participation looks like

You will receive the study medication (or placebo) intravenously six times over three days, with doses spaced 12 hours apart. You'll have brain imaging scans at the start, at 24 hours, and again on day 5 of the study. You'll also have neurological evaluations and follow-up assessments over the next 90 days to track your recovery. The entire study lasts about 3 months from your first dose.

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

Trial locations(2 sites)

South Korea

Dong-A University Hospital, Busan

Ulsan University Hospital, Ulsan