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A multicenter, prospective, post market "real-world" clinical study on the safety and efficacy of recombinant human TNK tissue type plasminogen activator for injection (rhTNK tPA) in the treatment of hyperacute ischemic stroke (onset<4.5 hours)

A multicenter, prospective, post market "real-world" clinical study on the safety and efficacy of recombinant human TNK tissue type plasminogen activator for injection (rhTNK tPA) in the treatment of hyperacute ischemic stroke (onset<4.5 hours)

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400083596
Enrollment
Unknown
Registered
2024-04-29
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-07-15

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

Conditions

Acute ischemic stroke (onset<4.5 hours)

Interventions

Case series:None

Sponsors

Linyi People's Hospital (Shandong Provincial Clinical Research Center for Geriatric Diseases)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age = 18 years old, regardless of gender; (2) mRS 0-1 before onset; (3) AIS patients treated with TNK thrombolysis (onset<4.5 hours); (4) The subject or guardian voluntarily signs an informed consent form.

Exclusion criteria

Exclusion criteria: (1) The patient refused to participate in this study or was unwilling to cooperate with a 90 day follow-up; (2) According to the judgment of the researchers, it is not suitable to participate in this study or participating in this study may lead to greater risks for the subjects.

Design outcomes

Primary

MeasureTime frame
The incidence of symptomatic intracranial hemorrhage within 36 hours (as defined by ECASSIII);90 day mRS score 0-1 points ratio;

Secondary

MeasureTime frame
The incidence of significant bleeding events in other areas within 90 days (as defined by GUSTO bleeding) ;90 day overall mortality rate ;Incidence rate of adverse events/serious adverse events within 90 days;Proportion of subjects with mRS0-2 scores at 90 ± 7 days;90 ± 7 day mRS level distribution;24-36 hours, 7 ± 1 days, or before discharge (whichever occurs first), NIHSS score 0-1 or improvement from baseline, the proportion of subjects with a NIHSS score of = 4;90 ± 7 days of health-related quality of life (EQ-5D);The proportion of subjects with a Bathel index = 95 points within 90 ± 7 days;

Countries

China

Contacts

Public ContactZiRan Wang

Linyi People's Hospital

wzr0806@163.com+86 139 5499 3801

Outcome results

None listed

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