Acute Ischemic StrokePRISMNCT07787325
Real-World Evaluation of Recombinant Human Prourokinase for Acute Ischemic Stroke Within 4.5 Hours
An observational study of Acute Ischemic Stroke, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Recombinant Human Prourokinase
- Type of treatment
- Injection or infusion
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2026to 31 Aug 2029
- Phase
- Observational
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Adults aged ≥18 years, regardless of sex.
- Pre-stroke modified Rankin Scale (mRS) score of 0-1.
- Patients with acute ischemic stroke treated within 4.5 hours of symptom onset, who are considered suitable for intravenous thrombolysis with recombinant human prourokinase by the treating investigator.
- Written informed consent obtained from the participant or legally authorized representative.
Who cannot join
- Known severe hypersensitivity to recombinant human prourokinase.
- Other severe neurological, psychiatric, or systemic diseases that may interfere with outcome assessment, adherence, or follow-up.
- Uncontrolled severe hypertension before treatment (systolic blood pressure ≥185 mmHg or diastolic blood pressure ≥110 mmHg despite antihypertensive therapy).
- Blood glucose <2.8 mmol/L or >22.2 mmol/L that remains uncontrolled after correction.
- Active internal bleeding or high bleeding risk, including gastrointestinal or urinary tract bleeding within 21 days, major surgery, severe trauma, major organ biopsy within 21 days, non-compressible arterial puncture within 7 days, or other significant bleeding risks.
- Known coagulation abnormalities or bleeding tendency, including platelet count <100 × 10⁹/L, INR >1.7, clinically significant PT prolongation, clinically significant APTT prolongation, or markedly decreased fibrinogen levels.
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- Current or recent anticoagulant use associated with increased bleeding risk, including vitamin K antagonists with INR >1.7, direct thrombin inhibitors or factor Xa inhibitors within 48 hours with abnormal coagulation tests, or heparin within 24 hours with elevated APTT.
- History of ischemic stroke, severe head trauma, or myocardial infarction within 3 months.
- History of intracranial hemorrhage.
- Intracranial or spinal surgery within 3 months.
- Known intracranial neoplasm, arteriovenous malformation, large intracranial aneurysm, or other intracranial lesions associated with increased risk of intracranial hemorrhage.
- Baseline CT showing intracranial hemorrhage, including intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural hematoma, or epidural hematoma.
- Extensive infarction or significant early ischemic changes on baseline imaging considered unsuitable for intravenous thrombolysis.
- Severe hepatic dysfunction, severe renal dysfunction, severe infection, active malignancy, terminal illness, or other serious conditions with expected survival <3 months.
- Pregnancy, breastfeeding, or positive pregnancy test in women of childbearing potential.
- Unable to complete 90-day follow-up, poor compliance, or other conditions considered unsuitable for study participation by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Wenchen Sun contact
China1 site
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000
Qiang Wei, +86 18788832124, qiangwei_914@126.com
Wenchen Sun, vince1240@163.com
About this study
Official title: A Prospective Multicenter Cohort Registry Study of Intravenous Recombinant Human Prourokinase for Acute Ischemic Stroke Within 4.5 Hours of Symptom Onset (PRISM)
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Recombinant Human Prourokinase
- Keywords
- Recombinant Human Prourokinase, Intravenous Thrombolysis, Acute Ischemic Stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human ProurokinaseDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| rhPro-UK-treated Acute Ischemic Stroke Cohort | Patients with acute ischemic stroke treated with intravenous recombinant human prourokinase within 4.5 hours of symptom onset. Receives: Drug: Recombinant Human Prourokinase |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days (±7 days) after treatment
Secondary outcomes (7)
Distribution of Modified Rankin Scale (mRS) Scores at 90 Days
The distribution of modified Rankin Scale (mRS) scores at 90 days after treatment.
Measured: 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.
Measured: 90 days (±7 days)
Barthel Index Score at 90 Days
Barthel Index score assessed at 90 days after treatment.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7 days (±1 day) or discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start11 Sep 2026 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panpan Hu, MD, The First Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787325
- Sponsor's protocol ID
- KY2026-09-90
- Acronym
- PRISM
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided