Urokinase for Thrombolysis in Acute Ischemic Stroke

NCT07047326 | Recruiting DMC

• 1 other identifier: OUTSET
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

According to the Chinese Guidelines for the Diagnosis and Treatment of Ischemic Stroke, intravenous thrombolysis with urokinase, administered at doses of 1-1.5 million IU within 6 hours of symptom onset, has been shown to be both safe and effective for patients with acute ischemic stroke. Compared to alteplase, urokinase offers considerable cost advantages while maintaining comparable therapeutic efficacy. However, current dosing protocols in clinical practice largely rely on the empirical judgment of physicians rather than evidence-based standardization. Therefore, the development of a weight-adjusted dosing regimen for urokinase is of significant clinical importance in optimizing treatment outcomes and ensuring patient safety. The purpose of this study is to determine the maximum tolerated dose of urokinase thrombolytic treatment in patients with acute ischemic stroke and to develop an optimal weight-adjusted dosing regimen.

Conditions

Acute Ischemic Stroke

Keywords

Acute ischemic stroke; Intravenous thrombolysis; Urokinase

Outcome Measures

Primary Outcomes (1)

• Number of participants with major response

  Major response is any of the following: 1. Symptomatic intracranial hemorrhage; 2. Parenchymal hemorrhage type 2; 3. Any intracranial hemorrhage; 4. Major bleeding and clinically relevant non-major bleeding.

  Within 36 hours after intravenous thrombolysis

Study Arms (1)

Intravenous urokinase group

EXPERIMENTAL

The safety and tolerability of urokinase will be investigated using a rolling six-dose escalation trial design.

Drug: Urokinase thrombolysis

Interventions

Urokinase thrombolysis DRUG

The intravenous thrombolysis group was administered urokinase dissolved in 100 mL of saline via continuous intravenous infusion for 30 min, and the treatment was given within 6 h of stroke onset. The dose escalation plan includes the following increments: 15,000 IU/kg (maximum dose: 1.5 million IU), 20,000 IU/kg (maximum dose: 2.0 million IU), 25,000 IU/kg (maximum dose: 2.5 million IU), and 30,000 IU/kg (maximum dose: 3.0 million IU).

Intravenous urokinase group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years, male or female.
• Clinical diagnosis as ischemic stroke (the diagnosis following the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023).
• Time from onset to treatment \<6h; the time of symptom onset is defined as "the last time point at which the patient appears normal", and the symptoms of stroke persist for at least 30 minutes and show no significant improvement before treatment.
• NIHSS ≥1 at baseline.
• Subjects or their guardians voluntarily sign the informed consent.

You may not qualify if:

• Head CT or MRI shows a large infarction (infarcted area \>1/3 of the middle cerebral artery).
• Unknown time of stroke onset.
• Pre-stroke mRS score ≥2.
• NIHSS score 1A ≥2.
• Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.).
• A history of intracranial hemorrhage.
• Propensity for acute bleeding, including platelet count \<100 × 10⁹/L or otherwise.
• Having received heparin treatment within 24 h.
• On oral anticoagulants (e.g., warfarin) with INR \>1.7 or PT \>15s.
• Patients with planned or prior endovascular therapy.
• A history of severe head trauma or stroke within 3 months.
• Intracranial tumors, large intracranial aneurysms.
• A history of intracranial or spinal surgery within 3 months.
• A history of major surgery within 2 weeks.
• Severe liver impairment (e.g., liver failure, cirrhosis, portal hypertension \[esophageal varices\], active hepatitis).

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

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

Ji Xunming

CONTACT

010-8319-9439; jixm@ccmu.edu.cn

Zhao Wenbo

CONTACT

010-8319-9048; zhaowb@xwh.ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 2, 2026
• Study Completion (Estimated): January 2, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)