Real-World Evaluation of Recombinant Human Prourokinase for Acute Ischemic Stroke Within 4.5 Hours

NCT07787325 | Not Yet Recruiting DMC

• 1 other identifier: KY2026-09-90
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

Acute ischemic stroke is a major cause of disability and death. Intravenous thrombolytic therapy is an important treatment option when given within the appropriate time window. Recombinant human prourokinase (rhPro-UK) is a thrombolytic medication approved for the treatment of acute ischemic stroke within 4.5 hours after symptom onset in China. This prospective, multicenter cohort registry study aims to evaluate the effectiveness and safety of intravenous rhPro-UK in patients with acute ischemic stroke treated within 4.5 hours of symptom onset. Approximately 3,000 patients from multiple centers will be enrolled and followed for 90 days. Clinical outcomes, bleeding events, adverse events, and functional recovery will be collected and analyzed to provide further evidence on the use of rhPro-UK in routine clinical practice.

Conditions

Acute Ischemic Stroke

Keywords

Recombinant Human Prourokinase; Intravenous Thrombolysis; Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Excellent Functional Outcome at 90 Days

  The proportion of participants achieving an excellent functional outcome at 90 days after intravenous recombinant human prourokinase treatment, defined as a modified Rankin Scale (mRS) score of 0-1.

  90 days (±7 days) after treatment

Secondary Outcomes (7)

• Distribution of Modified Rankin Scale (mRS) Scores at 90 Days

  90 days (±7 days) after treatment

• Functional Independence at 90 Days

  90 days (±7 days)

• Barthel Index Score at 90 Days

  90 days (±7 days)

• EQ-5D-5L Score at 90 Days

  90 days (±7 days)

• Early Neurological Improvement at 24 Hours

  24 hours (±6 hours) after treatment

Other Outcomes (9)

• Symptomatic Intracranial Hemorrhage Within 36 Hours

  Within 36 hours after treatment

• Any Intracranial Hemorrhage Within 36 Hours

  Within 36 hours after treatment

• All-Cause Mortality at 90 Days

  90 days (±7 days)

Study Arms (1)

rhPro-UK-treated Acute Ischemic Stroke Cohort

Patients with acute ischemic stroke treated with intravenous recombinant human prourokinase within 4.5 hours of symptom onset.

Drug: Recombinant Human Prourokinase

Interventions

Recombinant Human Prourokinase DRUG

Intravenous administration of recombinant human prourokinase for acute ischemic stroke within 4.5 hours of symptom onset. The total dose is 35 mg, consisting of a 15 mg intravenous bolus followed by 20 mg continuous infusion over 30 minutes.

rhPro-UK-treated Acute Ischemic Stroke Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with acute ischemic stroke who receive intravenous recombinant human prourokinase treatment within 4.5 hours of symptom onset. Eligible participants are patients aged ≥18 years with a pre-stroke modified Rankin Scale (mRS) score of 0-1 who are considered suitable for intravenous thrombolysis with recombinant human prourokinase by the treating investigator.

You may qualify if:

• Adults aged ≥18 years, regardless of sex.
• Pre-stroke modified Rankin Scale (mRS) score of 0-1.
• Patients with acute ischemic stroke treated within 4.5 hours of symptom onset, who are considered suitable for intravenous thrombolysis with recombinant human prourokinase by the treating investigator.
• Written informed consent obtained from the participant or legally authorized representative.

You may not qualify if:

• Known severe hypersensitivity to recombinant human prourokinase.
• Other severe neurological, psychiatric, or systemic diseases that may interfere with outcome assessment, adherence, or follow-up.
• Uncontrolled severe hypertension before treatment (systolic blood pressure ≥185 mmHg or diastolic blood pressure ≥110 mmHg despite antihypertensive therapy).
• Blood glucose \<2.8 mmol/L or \>22.2 mmol/L that remains uncontrolled after correction.
• Active internal bleeding or high bleeding risk, including gastrointestinal or urinary tract bleeding within 21 days, major surgery, severe trauma, major organ biopsy within 21 days, non-compressible arterial puncture within 7 days, or other significant bleeding risks.
• Known coagulation abnormalities or bleeding tendency, including platelet count \<100 × 10⁹/L, INR \>1.7, clinically significant PT prolongation, clinically significant APTT prolongation, or markedly decreased fibrinogen levels.
• Current or recent anticoagulant use associated with increased bleeding risk, including vitamin K antagonists with INR \>1.7, direct thrombin inhibitors or factor Xa inhibitors within 48 hours with abnormal coagulation tests, or heparin within 24 hours with elevated APTT.
• History of ischemic stroke, severe head trauma, or myocardial infarction within 3 months.
• History of intracranial hemorrhage.
• Intracranial or spinal surgery within 3 months.
• Known intracranial neoplasm, arteriovenous malformation, large intracranial aneurysm, or other intracranial lesions associated with increased risk of intracranial hemorrhage.
• Baseline CT showing intracranial hemorrhage, including intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural hematoma, or epidural hematoma.
• Extensive infarction or significant early ischemic changes on baseline imaging considered unsuitable for intravenous thrombolysis.
• Severe hepatic dysfunction, severe renal dysfunction, severe infection, active malignancy, terminal illness, or other serious conditions with expected survival \<3 months.
• Pregnancy, breastfeeding, or positive pregnancy test in women of childbearing potential.

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Qiang Wei

CONTACT

+86 18788832124; qiangwei_914@126.com

Wenchen Sun

CONTACT

vince1240@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurology Department, The First Affiliated Hospital of Anhui Medical University

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): September 11, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

CN (1)