Acute Ischemic StrokeNCT07047326
Urokinase for Thrombolysis in Acute Ischemic Stroke
A study testing Urokinase thrombolysis in people with Acute Ischemic Stroke, run by Capital Medical University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Urokinase thrombolysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesChina
- Study dates
- 1 Oct 2025to 2 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
- A history of gastrointestinal or urinary tract hemorrhage within 3 weeks.
- Active visceral bleeding.
- Aortic dissection found.
- A history of arterial puncture at sites difficult for compression hemostasis within 1 week.
- Life expectancy <1 year due to comorbid conditions.
- Uncontrollable hypertension upon active antihypertensive treatment: systolic blood pressure ≥180 mm Hg, or diastolic blood pressure ≥100 mm Hg on ≥3 repeated measurements at 10-minute intervals.
- Blood glucose <2.8 mmol/L or >22.2 mmol/L.
- Subjects who are unable or unwilling to cooperate due to hemiplegia after epileptic seizure or other neurological/psychiatric disorders.
- Known to be allergic to urokinase.
- Bacterial endocarditis, pericarditis, or acute pancreatitis.
- Participation in other clinical trials within 30 days before screening.
- Pregnancy, lactating women, or subjects who do not agree to use effective contraception during the trial.
- Other conditions deemed by the investigator to impair adherence or pose risks to participants.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Wenbo Zhao, M.D., zhaowb@xwh.ccmu.edu.cn
- Recruiting
Handan Central Hospital
Handan, Hebei, 056002
Shejun Feng
About this study
Official title: A Dose-Escalation Safety Study of Urokinase for Thrombolysis in Patients With Acute Ischemic Stroke
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
- Being tested
- Urokinase thrombolysis
- Keywords
- Acute ischemic stroke, Intravenous thrombolysis, Urokinase
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urokinase thrombolysisDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Intravenous urokinase group | Experimental | The safety and tolerability of urokinase will be investigated using a rolling six-dose escalation trial design. Receives: Drug: Urokinase thrombolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with major response
Major response is any of the following:
- Symptomatic intracranial hemorrhage;
- Parenchymal hemorrhage type 2;
- Any intracranial hemorrhage;
- Major bleeding and clinically relevant non-major bleeding.
Measured: Within 36 hours after intravenous thrombolysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start1 Oct 2025
- Primary completion2 Oct 2026 (estimated)
- Study completion2 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047326
- Sponsor's protocol ID
- OUTSET
- Status last verified
- Jul 2026
- First submitted
- 24 Jun 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.
Publications
Wang S, Ma Q, Ji X, Zhao W, Wu L. Urokinase for thrombolysis in patients with acute ischemic stroke: rationale and design of a phase I dose-escalation study. Front Neurol. 2026 Apr 15;17:1750720. doi: 10.3389/fneur.2026.1750720. eCollection 2026.
PubMed 42064982
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Escalation Safety Study of Urokinase for Thrombolysis in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07047326
- Acronym / sponsor ID
- OUTSET
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute ischemic stroke, Intravenous thrombolysis, Urokinase
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 2 Oct 2026 (estimated)
- Study completion
- 2 Jan 2027 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravenous urokinase group | Experimental | Drug: Urokinase thrombolysisThe safety and tolerability of urokinase will be investigated using a rolling six-dose escalation trial design. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urokinase thrombolysisThe 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). | Drug | Intravenous urokinase group |
Primary outcome
Number of participants with major response
Time frame: Within 36 hours after intravenous thrombolysis
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Derived from this study: PubMed 42064982Wang S, Ma Q, Ji X, Zhao W, Wu L. Urokinase for thrombolysis in patients with acute ischemic stroke: rationale and design of a phase I dose-escalation study. Front Neurol. 2026 Apr 15;17:1750720. doi: 10.3389/fneur.2026.1750720. eCollection 2026.
- Individual participant dataSharing planned: Yes. Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urokinase thrombolysis in people with Acute Ischemic Stroke, run by Capital Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ji Xunming (010-8319-9439, jixm@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with major response (time frame: Within 36 hours after intravenous thrombolysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07047326, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.