An observational study in Acute Ischemic Stroke, sponsored by The First Affiliated Hospital of Anhui Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by The First Affiliated Hospital of Anhui Medical University · Observational
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.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 300 across 771 observational studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →The First Affiliated Hospital of Anhui Medical University is the lead sponsor of 43 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with acute ischemic stroke treated with intravenous recombinant human prourokinase within 4.5 hours of symptom onset.
Drug: Recombinant Human Prourokinase
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.
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.
Time frame: 90 days (±7 days) after treatment
Distribution of Modified Rankin Scale (mRS) Scores at 90 Days
The distribution of modified Rankin Scale (mRS) scores at 90 days after treatment.
Time frame: 90 days (±7 days) after treatment
Functional Independence at 90 Days
The proportion of participants achieving functional independence at 90 days, defined as a modified Rankin Scale (mRS) score of 0-2.
Time frame: 90 days (±7 days)
Barthel Index Score at 90 Days
Barthel Index score assessed at 90 days after treatment.
Time frame: 90 days (±7 days)
EQ-5D-5L Score at 90 Days
Health-related quality of life assessed using the EuroQol five-dimensional five-level questionnaire (EQ-5D-5L).
Time frame: 90 days (±7 days)
Early Neurological Improvement at 24 Hours
The proportion of participants achieving early neurological improvement at 24 hours, defined as NIHSS score of 0-1 or improvement of ≥4 points from baseline.
Time frame: 24 hours (±6 hours) after treatment
Change in NIHSS Score at 24 Hours
Change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours after treatment.
Time frame: 24 hours (±6 hours)
Change in NIHSS Score at 7 Days or Discharge
Change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 7 days or discharge, whichever occurs first.
Time frame: 7 days (±1 day) or discharge
Symptomatic Intracranial Hemorrhage Within 36 Hours
The incidence of symptomatic intracranial hemorrhage within 36 hours after treatment according to the SITS-MOST definition.
Time frame: Within 36 hours after treatment
Any Intracranial Hemorrhage Within 36 Hours
The incidence of any intracranial hemorrhage within 36 hours after treatment according to Heidelberg bleeding classification criteria.
Time frame: Within 36 hours after treatment
All-Cause Mortality at 90 Days
All-cause mortality within 90 days after treatment.
Time frame: 90 days (±7 days)
Serious Adverse Events Within 90 Days
The incidence of serious adverse events within 90 days after treatment.
Time frame: 90 days (±7 days)
Adverse Events Within 90 Days
The incidence of adverse events within 90 days after treatment.
Time frame: 90 days (±7 days)
Symptomatic Intracranial Hemorrhage Within 36 Hours
Incidence of symptomatic intracranial hemorrhage within 36 hours after intravenous recombinant human prourokinase treatment according to the ECASS III definition.
Time frame: Within 36 hours after treatment
Symptomatic Intracranial Hemorrhage Within 36 Hours
Incidence of symptomatic intracranial hemorrhage within 36 hours after treatment according to the Heidelberg bleeding classification criteria.
Time frame: Within 36 hours after treatment
All-Cause Mortality at 7 Days or Discharge
All-cause mortality occurring by 7 days after treatment or hospital discharge, whichever occurs first.
Time frame: 7 days (±1 day) or discharge
Moderate or Severe Systemic Bleeding Within 90 Days
Incidence of moderate or severe systemic bleeding events within 90 days after treatment according to the Global Use of Strategies to Open Occluded Arteries (GUSTO) classification.
Time frame: 90 days (±7 days) after treatment
Plan to share: Undecided
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Anhui Medical University