A multi-center, prospective, post-marketing "real world" clinical study on the efficacy and safety of rhPro-UK in the treatment of acute ischemic stroke (treatment within 4.5 hours of onset )

A multi-center, prospective, post-marketing "real world" clinical study on the efficacy and safety of rhPro-UK in the treatment of acute ischemic stroke (treatment within 4.5 hours of onset)

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2600126115

Enrollment

Unknown

Registered

2026-06-03

Start date

2026-06-03

Completion date

Unknown

Last updated

2026-06-08

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

Conditions

Acute ischemic stroke (treatment within 4.5 hours of onset)

Interventions

Cohort study:None

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years, any gender; 2. Pre-stroke mRS score of 0-1; 3. Acute ischemic stroke (within 4.5 hours of onset), judged by the investigator eligible for intravenous thrombolysis with recombinant human urokinase; 4. Subject or guardian voluntarily signs the 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

Measure	Time frame
Intravenous thrombolysis alone efficacy indicator:90 days mRS score 0-1 points ratio;Incidence of symptomatic intracranial hemorrhage (according to ECASSIII criteria and SITS-MOST criteria);	—

Secondary

Measure	Time frame
Intravenous thrombolysis alone efficacy indicator:90 +/-7 days mRS score 0-2 points ratio;Intravenous thrombolysis alone efficacy indicator:90 +/-7 days mRS level distribution;Intravenous thrombolysis alone efficacy indicator:Proportion of subjects whose NIHSS score was 0-1 points or whose NIHSS score improved by ?NIHSS = 4 points from baseline 7 +/-1 days or before discharge (whichever occurs first);Intravenous thrombolysis alone efficacy indicator:90 +/-7 days health-related quality of life score (EQ-5D);Intravenous thrombolysis alone efficacy indicator:Proportion of subjects with Bathel index =95 within 90 +/-7 days;rhPro-UK-plus-thrombectomy efficacy indicator:90 +/-7 day mRS score 0-2 points ratio;rhPro-UK-plus-thrombectomy efficacy indicator:90 +/- 7 days mRS level distribution;rhPro-UK-plus-thrombectomy efficacy indicator:90 +/-7 days health-related quality of life score (EQ-5D);Incidence of asymptomatic intracranial hemorrhage within 7 days;Incidence of significant bleeding events at other sites within 7 days (Incidence of major bleeding, incidence of non-serious bleeding, defined according to ISTH);Overall mortality rate within 7 days;Overall mortality within 90 days;	—

Measure

Time frame

Intravenous thrombolysis alone efficacy indicator:90 +/-7 days mRS score 0-2 points ratio;Intravenous thrombolysis alone efficacy indicator:90 +/-7 days mRS level distribution;Intravenous thrombolysis alone efficacy indicator:Proportion of subjects whose NIHSS score was 0-1 points or whose NIHSS score improved by ?NIHSS = 4 points from baseline 7 +/-1 days or before discharge (whichever occurs first);Intravenous thrombolysis alone efficacy indicator:90 +/-7 days health-related quality of life score (EQ-5D);Intravenous thrombolysis alone efficacy indicator:Proportion of subjects with Bathel index =95 within 90 +/-7 days;rhPro-UK-plus-thrombectomy efficacy indicator:90 +/-7 day mRS score 0-2 points ratio;rhPro-UK-plus-thrombectomy efficacy indicator:90 +/- 7 days mRS level distribution;rhPro-UK-plus-thrombectomy efficacy indicator:90 +/-7 days health-related quality of life score (EQ-5D);Incidence of asymptomatic intracranial hemorrhage within 7 days;Incidence of significant bleeding events at other sites within 7 days (Incidence of major bleeding, incidence of non-serious bleeding, defined according to ISTH);Overall mortality rate within 7 days;Overall mortality within 90 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: Jun 11, 2026