Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing TNK-tPA for Acute Ischemic Stroke

The goal of this clinical trial is to measure the how well it works and safety of tenecteplase administered 4.5-9 hours after stroke onset (defined as the time the patient was first found with symptoms, including wake-up stroke and unwitnessed stroke) in patients with acute ischemic stroke (AIS) guided by DWI-FLAIR mismatch on MRI. The main questions it aims to answer are: 1.

Official registry: https://clinicaltrials.gov/study/NCT07540416 · The First Affiliated Hospital of Zhengzhou University · enrollment listed as 564

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are TNK-tPA, Aspirin, or Placebo. The registry lists allocation as randomized. The goal of this clinical trial is to measure the how well it works and safety of tenecteplase administered 4.5-9 hours after stroke onset (defined as the time the patient was first found with symptoms, including wake-up stroke and unwitnessed stroke) in patients with acute ischemic stroke (AIS) guided by DWI-FLAIR mismatch on MRI.

They plan to enroll about 564 people at Zhengzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Tenecteplase Thrombolysis for Acute Ischemic Stroke in the 4.5-9-Hour Window Guided by DWI-FLAIR Mismatch: A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial

Interventions: TNK-tPA, Aspirin, Placebo, Placebo

Primary outcome (registry wording): Modified Rankin Scale (mRS)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • AIS with symptom onset 4.5-9 hours before enrollment, including wake-up stroke and unwitnessed stroke (onset time defined as when symptoms were first noticed);
  • DWI-FLAIR mismatch: visible lesion on DWI with no marked visible lesion on FLAIR;
  • DWI infarct core not exceeding one-third of the middle cerebral artery territory, one-half of the anterior cerebral artery territory, or one-half of the posterior cerebral artery territory;
  • First-ever stroke or previous stroke without significant disability (pre-stroke mRS ≤ 1);

Public study contact (from the registry)

Bo Song, MD

+86-371-66278068

fccsongb@zzu.edu.cn

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07540416 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07540416?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07540416?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary