Weight-adjusted urokinase dosing for early ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional dose-finding study will administer intravenous urokinase to adults with acute ischemic stroke within 6 hours of symptom onset using a stepwise dose-escalation approach to determine the maximum tolerated dose. Eligible participants (ages 18–80, NIHSS ≥1) without large infarction or intracranial hemorrhage will be closely monitored for bleeding events and clinical outcomes. Data on dose, patient weight, and safety events will be analyzed to derive a standardized weight-adjusted dosing regimen. The study aims to replace currently empirical dosing with evidence-based guidance to improve safety and consistency of urokinase thrombolysis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18-80 years, male or female.
2. Clinical diagnosis as ischemic stroke (the diagnosis following the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023).
3. 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.
4. NIHSS ≥1 at baseline.
5. Subjects or their guardians voluntarily sign the informed consent.

Exclusion Criteria:

1. Head CT or MRI shows a large infarction (infarcted area \>1/3 of the middle cerebral artery).
2. Unknown time of stroke onset.
3. Pre-stroke mRS score ≥2.
4. NIHSS score 1A ≥2.
5. Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.).
6. A history of intracranial hemorrhage.
7. Propensity for acute bleeding, including platelet count \<100 × 10⁹/L or otherwise.
8. Having received heparin treatment within 24 h.
9. On oral anticoagulants (e.g., warfarin) with INR \>1.7 or PT \>15s.
10. Patients with planned or prior endovascular therapy.
11. A history of severe head trauma or stroke within 3 months.
12. Intracranial tumors, large intracranial aneurysms.
13. A history of intracranial or spinal surgery within 3 months.
14. A history of major surgery within 2 weeks.
15. Severe liver impairment (e.g., liver failure, cirrhosis, portal hypertension \[esophageal varices\], active hepatitis).
16. A history of gastrointestinal or urinary tract hemorrhage within 3 weeks.
17. Active visceral bleeding.
18. Aortic dissection found.
19. A history of arterial puncture at sites difficult for compression hemostasis within 1 week.
20. Life expectancy \<1 year due to comorbid conditions.
21. 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.
22. Blood glucose \<2.8 mmol/L or \>22.2 mmol/L.
23. Subjects who are unable or unwilling to cooperate due to hemiplegia after epileptic seizure or other neurological/psychiatric disorders.
24. Known to be allergic to urokinase.
25. Bacterial endocarditis, pericarditis, or acute pancreatitis.
26. Participation in other clinical trials within 30 days before screening.
27. Pregnancy, lactating women, or subjects who do not agree to use effective contraception during the trial.
28. Other conditions deemed by the investigator to impair adherence or pose risks to participants.

Where it's running

• Xuanwu Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Handan Central Hospital
  Handan, Hebei, China Recruiting

Study contacts

• Study coordinator: Ji Xunming
• Email: jixm@ccmu.edu.cn
• Phone: 010-8319-9439

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Short-Term outside-in nerve stimulation for acute ischemic stroke

  This trial tests whether a 5-day external trigeminal nerve stimulation given after stroke can help more patients recover better than a sham treatment.

  Recruiting Xidian University · Xi'an · NCT07911605

• Sevoflurane vs. Propofol for anesthesia in stroke patients undergoing clot-removal

  This study tests whether sevoflurane or propofol used for anesthesia during endovascular treatment of an acute ischemic stroke affects the final brain damage and recovery.

  Recruiting Phase 3 Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Barcelona · NCT07902791

• Safety of adding NRICM301 to standard care for adults with acute ischemic stroke

  This study tests whether adding NRICM301, a traditional Chinese medicine formula, to usual care is safe for adults with acute ischemic stroke.

  Recruiting En Chu Kong Hospital · New Taipei City · NCT07900503

• Intracranial Recanalization with LT3001 in Acute Ischemic Stroke

  This phase II study tests whether LT3001 given to adults with acute ischemic stroke can help reopen blocked brain arteries.

  Recruiting Phase 2 Lumosa Therapeutics Co., Ltd. · Taichung · NCT07890298

• Mobilisation After Endovascular Stroke Treatment

  This study checks whether moving around 12 hours after endovascular stroke treatment is as safe as moving around 24 hours for people with an acute ischemic stroke.

  Recruiting at 2 sites Karolinska Institutet · Tampere and 1 other locations · NCT07860333

• Endovascular therapy plus standard care vs standard care alone for distal and medium vessel strokes

  In people with acute ischemic stroke due to distal or medium vessel blockages, this study tests whether adding endovascular treatment to the usual medical care helps improve outcomes compared with medical care alone.

  Recruiting Hospital Universitari Vall d'Hebron Research Institute · Barcelona, Barcelona · NCT07843797

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.