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
- 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 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07787325
- Acronym / sponsor ID
- PRISM / KY2026-09-90
- Conditions
- Acute Ischemic Stroke
- Keywords
- Recombinant Human Prourokinase, Intravenous Thrombolysis, Acute Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 11 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 26 Aug 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rhPro-UK-treated Acute Ischemic Stroke Cohort | – | Drug: Recombinant Human ProurokinasePatients with acute ischemic stroke treated with intravenous recombinant human prourokinase within 4.5 hours of symptom onset. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
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 |
|---|---|---|
| Recombinant Human ProurokinaseIntravenous 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. | Drug | rhPro-UK-treated Acute Ischemic Stroke Cohort |
Primary outcome
Excellent Functional Outcome at 90 Days
Time frame: 90 days (±7 days) after treatment
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.
7 secondary outcomes
Distribution of Modified Rankin Scale (mRS) Scores at 90 Days
Time frame: 90 days (±7 days) after treatment
Functional Independence at 90 Days
Time frame: 90 days (±7 days)
Barthel Index Score at 90 Days
Time frame: 90 days (±7 days)
EQ-5D-5L Score at 90 Days
Time frame: 90 days (±7 days)
Early Neurological Improvement at 24 Hours
Time frame: 24 hours (±6 hours) after treatment
Change in NIHSS Score at 24 Hours
Time frame: 24 hours (±6 hours)
Change in NIHSS Score at 7 Days or Discharge
Time frame: 7 days (±1 day) or discharge
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 26 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Wenchen Sun contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by The First Affiliated Hospital of Anhui Medical University at 1 site 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 4 inclusion and 16 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: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Qiang Wei (+86 18788832124, qiangwei_914@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excellent Functional Outcome at 90 Days (time frame: 90 days (±7 days) after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2026.