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New treatment option for Acute Ischemic Stroke
Official title Urokinase for Thrombolysis in Acute Ischemic Stroke
ClinicalTrials.gov ID: NCT07047326
What this study is testing
What is Urokinase thrombolysis?
Urokinase thrombolysis is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute ischemic stroke.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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...
- NIHSS ≥1 at baseline.
- people or their guardians voluntarily sign the informed consent.
You likely can't join 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.
See the full eligibility criteria
- 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...
- NIHSS ≥1 at baseline.
- people or their guardians voluntarily sign the informed consent.
- 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).
- 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 \ 22.2 mmol/L.
- people 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 people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Handan, Hebei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Handan, Hebei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.