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 Alteplase for Stroke, Acute Ischemic

The NEWLINE trial is a multicenter, randomly assigned, open-label, blinded endpoint (PROBE) trial evaluating whether added on top of your current treatment low-dose intra-arterial alteplase administered immediately after successful endovascular thrombectomy improves functional outcomes in adults with acute ischemic stroke due to anterior circulation large vessel occlusion. Eligible participants achieving successful reperfusion (eTICI 2b-3) within 24 hours of symptom onset will be randomly assigned 1:1 to receive intra-arterial alteplase plus standard care or standard care alone.

Official registry: https://clinicaltrials.gov/study/NCT07727395 · 115 People's Hospital · enrollment listed as 416

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 Alteplase, or Endovascular thrombectomy. The registry lists allocation as randomized. The NEWLINE trial is a multicenter, randomly assigned, open-label, blinded endpoint (PROBE) trial evaluating whether added on top of your current treatment low-dose intra-arterial alteplase administered immediately after successful endovascular thrombectomy improves functional outcomes in adults with acute ischemic stroke due to anterior circulation large vessel occlusion.

They plan to enroll about 416 people at 13 sites. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.

Official title (unrewritten)

INtra-arterial AltEplase folloWing successfuL reperfusIoN After mEchanical Thrombectomy

Interventions: Alteplase, Endovascular thrombectomy

Primary outcome (registry wording): Modified Rankin Scale at day 90

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Age ≥ 18 years old
  • No significant pre-stroke functional disability (pre-stroke mRS 0-1)
  • Clinical diagnosis of acute ischemic stroke with anterior LVO
  • Time from symptom onset to randomization within 24 hours, including wake-up stroke or unwitness stroke; the onset time refers to "Last Known Well" (LKW)
  • Baseline NIHSS of 6 - 25
  • Non-contrast CT (NCCT) or diffusion-weighted imaging (DWI)-MRI Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6. For patients with available perfusion imaging (CTP/MRP), additional criteria include: Ischemic core volume ≤ 70mL; Mismatch volume ≥ 15 ml; Mismatch ratio ≥ 1.8
  • Evidence of oclussion of the intracranial segment of the internal carotid artery (ICA), or M1 or M2 segment of the middle cerebral artery (MCA) on CT angiography (CTA) or MR angiography (MRA)

Public study contact (from the registry)

Thang H Nguyen, Assoc. Prof.

+84909982115

nguyenhuythang115@gmail.com

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

Sites listed on ClinicalTrials.gov

13 listed

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FAQ about this NCT record

Is NCT07727395 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 NCT07727395?

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 NCT07727395?

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