NCT07668323 Alteplase Acute Ischemic Stroke Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07668323 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 21 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07668323 is a hot trial to watch
Acute Ischemic Stroke is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07668323 is notable because it evaluates Alteplase in a Phase 3 design sponsored by Third Affiliated Hospital of Nanjing Medical University. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07668323 |
| Official title | Intra-arterial Thrombolysis For Acute Ischemic Stroke With Medium Vessel Occlusion (IAT-MEVO) |
| Phase / status | Phase 3 / Not yet recruiting |
| Intervention | Alteplase |
| Sponsor | Third Affiliated Hospital of Nanjing Medical University |
| Geography | China |
| Enrollment | 306 |
| Primary endpoint | Proportion of patients with favorable functional outcome at 90 days |
| Endpoint time frame | 90 days post-randomization (90±7 days) |
| Primary completion / readout proxy | 2028-07-30 |
Protocol design and endpoint interpretation
Study purpose: A multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) phase III trial is planned to evaluate the efficacy and safety of intra-arterial thrombolysis (IAT) in patients with acute ischemic stroke caused by medium vessel occlusion (MeVO), compared with best medical management alone. Eligible participants (aged 18-80 years, baseline NIHSS score 6-25 or 3-5 with disabling deficits, confirmed MeVO within 24 hours of symptom onset) will be randomly assigned 1:1 to the intra-arterial thrombolysis plus best medical management group or the best medical management alone group. Primary endpoint: proportion of patients with favorable functional outcome (modified Rankin Scale score 0-2) at 90±7 days post-randomization. Secondary endpoints: 1. Recanalization rate (meTICI ≥ 2b) at 24±12 hours post-randomization; 2. Early neurological improvement (NIHSS score change from baseline) at 7±1 days or discharge; 3. Overall
Allocation is Randomized, masking is Single, and the intervention model is Parallel Assignment. Planned enrollment of 306 participants across China shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Proportion of patients with favorable functional outcome at 90 days (90 days post-randomization (90±7 days)) — Favorable functional outcome is defined as a modified Rankin Scale (mRS) score of 0 to 2, assessed at 90±7 days post-randomization. The mRS is a 7-point ordinal scale (range 0-6) measuring functional independence and disability, with 0 indicating no symptoms and 6 indicating death.
Readout outlook and evidence gap
The current protocol points to 2028-07-30 as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Trial-sourced asset: Alteplase. The Drug & Asset MCP enrichment step is designed to add normalized targets, modality and global development status when an exact asset match is available.
Trial-sourced sponsor: Third Affiliated Hospital of Nanjing Medical University. Company & Deal Intelligence MCP is the companion workflow for resolving organization identity, corporate profile and partnering context.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07668323 provides a focused lens on Acute Ischemic Stroke development. Its value will be determined by whether Alteplase can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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