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the efficacy and satety of Recombinant human TNK tissue type plasminogen activator injection for acte ischemic stroke patient within time window: a multi-center, real-world clinical trial .

the efficacy and satety of Recombinant human TNK tissue type plasminogen activator injection for acte ischemic stroke patient within time window: a multi-center, real-world clinical trial .

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091525
Enrollment
Unknown
Registered
2024-10-30
Start date
2024-10-30
Completion date
Unknown
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute ischemic stroke

Interventions

Experimental group:rhTNK-tPA

Sponsors

China-Japan Union Hospital of Jilin Universtiy
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age = 18 years old, gender not limited; (2) MRS score 0-1 before onset; (3) AIS patients (onset<4.5 hours) who meet the clinical criterion for thrombolysis in accordance with the Chinese guidelines for the diagnosis and treatment of ischemic stroke and receive TNK thrombolysis therapy; (4) The patient or guardian voluntarily signs the informed consent form.

Exclusion criteria

Exclusion criteria: (1) The patient refused to participate in this study or refused to cooperate with the 90 day follow-up; (2) According to the researcher's judgment, it is not suitable to participate in this study or participating in this study may lead to the subjects face greater risks.

Design outcomes

Primary

MeasureTime frame
The proportion of mRS score 0-1 on Day 90 ± 7 follow-up visit;Incidence of symptomatic intracranial hemorrhage within 48 hours;

Secondary

MeasureTime frame
the Proportion of mRS score 0-2 on Day 90 ± 7 follow-up visit;mRS level distribution on Day 90 ± 7;NIHSS score of 0-1 or The proportion of patiients whose NIHSS score improved by ? NIHSS = 4 points compared to baseline on 24 ± 12h, 7 ± 1d, or before discharge (whichever occurs first);The incidence of significant bleeding events in other parts within 90 days;90 day overall mortality rate;Incidence of adverse events/serious adverse events within 90 days;

Countries

China

Contacts

Public ContactLu-mei Chi

China-Japan Union Hospital of Jilin Universtiy

chilm@jlu.edu.cn+86 135 0430 9790

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026