Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

Extended-Window Intravenous ThrombolysisRecombinant Human ProurokinaseNoncontrast Computed TomographyArtificial IntelligenceTissue-Window SelectionPerfusion Mismatch

Outcome Measures

Primary Outcomes (1)

Proportion of Participants With a Modified Rankin Scale Score of 0-1 at 90 Days
The proportion of participants achieving a modified Rankin Scale (mRS) score of 0 or 1. The mRS ranges from 0 (no symptoms) to 6 (death), with lower scores indicating better functional outcomes.
90 ± 7 days after randomization

Secondary Outcomes (6)

Ordinal Distribution of Modified Rankin Scale Scores at 90 Days
90 ± 7 days after randomization
Proportion of Participants With a Modified Rankin Scale Score of 0-2 at 90 Days
90 ± 7 days after randomization
Proportion of Participants With a Modified Rankin Scale Score of 0-3 at 90 Days
90 ± 7 days after randomization
Change in National Institutes of Health Stroke Scale Score From Baseline to 24 Hours
Baseline and 24 hours after randomization
Change in National Institutes of Health Stroke Scale Score From Baseline to Day 7
Baseline and 7 days after randomization
+1 more secondary outcomes

Other Outcomes (3)

Incidence of Symptomatic Intracranial Hemorrhage Within 36 Hours
Within 36 hours after randomization
Incidence of Parenchymal Hematoma Within 36 Hours
Within 36 hours after randomization
All-Cause Mortality at 90 Days
90 ± 7 days after randomization

Study Arms (2)

Recombinant Human Prourokinase Group

EXPERIMENTAL

Participants will receive intravenous recombinant human prourokinase (rhPro-UK), 35 mg, in addition to guideline-recommended standard stroke care.

Drug: Recombinant Human Prourokinase for Injection (rhPro-UK)

Matching Placebo Group

PLACEBO COMPARATOR

Participants will receive matching intravenous placebo in addition to the same guideline-recommended standard stroke care.

Drug: Matching Placebo for Recombinant Human Prourokinase

Interventions

Recombinant Human Prourokinase for Injection (rhPro-UK)Drug

A total dose of 35 mg will be administered intravenously. The initial 15 mg dissolved in 10 mL solution will be administered by intravenous bolus over 3 minutes, followed by 20 mg dissolved in 90 mL solution administered by intravenous infusion over 30 minutes.

Recombinant Human Prourokinase Group

Matching Placebo for Recombinant Human ProurokinaseDrug

Matching placebo will be administered intravenously using the same administration volumes, route, and durations as the active study drug to maintain blinding.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Control intervention
Matching Placebo for Recombinant Human Prourokinase
The registry describes a control or simulated intervention. Active treatment exposure is not inferred.
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥18 years.
Clinically diagnosed acute ischemic stroke.

Sponsors & Collaborators

Second Affiliated Hospital, Zhejiang University, School of Medicine
Otherlead

Study Sites (1)

Department of Neurology, the Second Affiliated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhengjiang, 310009, China

Min Lou, PhD, MDCONTACT+8657187784810 lm99@zju.edu.cn

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Injections

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

Min Lou, PhD, MD
Second Affiliated Hospital, Zhejiang University, School of Medicine
PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Lou, PhD, MD

CONTACT

+8613958007213 lm99@zju.edu.cn

Wansi Zhong, MD

CONTACT

+8618757155806

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Dr.

Study Record Dates

First Submitted

October 21, 2026

First Posted

October 28, 2026

Study Start

December 1, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

Recombinant Human Prourokinase for Acute Ischemic Stroke in the Extended Window Selected by CT-Based Artificial Intelligence

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Other Outcomes (3)

Study Arms (2)

Recombinant Human Prourokinase Group

Matching Placebo Group

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Other Outcomes (3)

Study Arms (2)

Recombinant Human Prourokinase Group

Matching Placebo Group

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations