Acute Ischemic StrokePhase 3RAISE-AINCT07901842
Recombinant Human Prourokinase for Acute Ischemic Stroke in the Extended Window Selected by CT-Based Artificial Intelligence
A Phase 3 study testing Recombinant Human Prourokinase for Injection (rhPro-UK) in people with Acute Ischemic Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This multicenter, prospective, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of intravenous recombinant human prourokinase (rhPro-UK) in patients with acute ischemic stroke treated more than 4.5 hours and up to 24 hours after stroke onset, selected using a noncontrast… 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 for Injection (rhPro-UK)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 826 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2026to 1 Jun 2030
- Phase
- Phase 3
- 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
Who may be able to join
- Age ≥18 years.
- Clinically diagnosed acute ischemic stroke.
- Time from stroke onset to randomization >4.5 hours and ≤24 hours. For patients with unknown onset time or wake-up stroke, the estimated onset time will be defined as the midpoint between the last known well time and symptom discovery time.
- Baseline National Institutes of Health Stroke Scale (NIHSS) score of 4-25.
- Pre-stroke modified Rankin Scale (mRS) score of 0-1.
- No planned endovascular treatment at randomization. Patients with large vessel occlusion who are eligible for endovascular treatment must undergo independent evaluation and discussion before study enrollment. Patients who are planned to receive endovascular treatment will not be enrolled.
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- Meeting the CT-AI tissue-window selection criteria:
- Predicted ischemic core volume ≤70 mL;
- Hypoperfusion-to-core volume ratio >1.2;
- Difference between hypoperfusion and ischemic core volumes ≥10 mL.
- Written informed consent provided by the participant or their legally authorized representative.
Who cannot join
- Baseline CT showing intracranial hemorrhage, subarachnoid hemorrhage, brain tumor, brain abscess, or other non-ischemic lesions.
- Baseline CT showing an extensive infarction, severe cerebral edema, or mass effect, or the investigator determines that the risks of intravenous thrombolysis substantially outweigh the potential benefits.
- Contraindications specified in the prescribing information for recombinant human prourokinase for injection or current intravenous thrombolysis guidelines, other than the extended treatment time window specifically evaluated in this trial, including but not limited to:
- Any history of intracranial hemorrhage;
- Severe head trauma or stroke, including ischemic stroke, within the previous 3 months;
- Recent major surgery or severe trauma;
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- Active internal bleeding;
- Significant coagulation abnormalities;
- Platelet count <100 × 10⁹/L;
- Blood pressure that cannot be adequately controlled to meet intravenous thrombolysis requirements despite treatment;
- Other conditions associated with substantially increased bleeding risk as determined by the investigator.
- Pregnancy, breastfeeding, or unwillingness to use effective contraception during the study.
- Inadequate NCCT image quality for CT-AI analysis or inability of the AI model to generate valid outputs.
- Participation in another interventional clinical trial within the previous 3 months.
- Expected survival of less than 3 months.
- Other conditions considered by the investigator to increase the risk of study treatment or interfere with study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Neurology, the Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhengjiang, 310009
Min Lou, PhD, MD, +8657187784810, lm99@zju.edu.cn
About this study
Official title: Intravenous Recombinant Human Prourokinase for Extended-Window Acute Ischemic Stroke Selected by NCCT-Based Artificial Intelligence: A Randomized Controlled Trial
This multicenter, prospective, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of intravenous recombinant human prourokinase (rhPro-UK) in patients with acute ischemic stroke treated more than 4.5 hours and up to 24 hours after stroke onset, selected using a noncontrast computed tomography-based artificial intelligence (CT-AI) tissue-window algorithm.
A total of 826 participants will be randomly assigned in a 1:1 ratio to receive intravenous rhPro-UK or matching placebo, in addition to guideline-recommended standard stroke care.
The primary outcome is the proportion of participants achieving a modified Rankin Scale (mRS) score of 0-1 at 90 ± 7 days. Secondary outcomes include functional outcomes, changes in neurological deficits, early neurological improvement at 24 hours and 7 days, and tissue reperfusion at 24-48 hours. Safety outcomes include symptomatic intracranial hemorrhage, parenchymal hematoma, all-cause mortality, and serious systemic bleeding.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Recombinant Human Prourokinase for Injection (rhPro-UK), Matching Placebo for Recombinant Human Prourokinase
- Keywords
- Extended-Window Intravenous Thrombolysis, Recombinant Human Prourokinase, Noncontrast Computed Tomography, Artificial Intelligence, Tissue-Window Selection, Perfusion Mismatch
- 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 Prourokinase for Injection (rhPro-UK)Drug
A total dose of 35 mg will be administered intravenously. The initial 15 mg dissolved in 10 mL solution will be administered by intravenous bolus over 3 minutes, followed by 20 mg dissolved in 90 mL solution administered by intravenous infusion over 30 minutes.
Matching Placebo for Recombinant Human ProurokinaseDrug
Matching placebo will be administered intravenously using the same administration volumes, route, and durations as the active study drug to maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Human Prourokinase Group | Experimental | Participants will receive intravenous recombinant human prourokinase (rhPro-UK), 35 mg, in addition to guideline-recommended standard stroke care. Receives: Drug: Recombinant Human Prourokinase for Injection (rhPro-UK) |
| Matching Placebo Group | Placebo comparator | Participants will receive matching intravenous placebo in addition to the same guideline-recommended standard stroke care. Receives: Drug: Matching Placebo for Recombinant Human Prourokinase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With a Modified Rankin Scale Score of 0-1 at 90 Days
The proportion of participants achieving a modified Rankin Scale (mRS) score of 0 or 1. The mRS ranges from 0 (no symptoms) to 6 (death), with lower scores indicating better functional outcomes.
Measured: 90 ± 7 days after randomization
Secondary outcomes (6)
Ordinal Distribution of Modified Rankin Scale Scores at 90 Days
The distribution of modified Rankin Scale (mRS) scores from 0 (no symptoms) to 6 (death), with higher scores indicating worse functional outcomes.
Measured: 90 ± 7 days after randomization
Proportion of Participants With a Modified Rankin Scale Score of 0-2 at 90 Days
The proportion of participants achieving an mRS score of 0-2. The mRS ranges from 0 (no symptoms) to 6 (death).
Measured: 90 ± 7 days after randomization
Proportion of Participants With a Modified Rankin Scale Score of 0-3 at 90 Days
The proportion of participants achieving an mRS score of 0-3. The mRS ranges from 0 (no symptoms) to 6 (death).
Measured: 90 ± 7 days after randomization
Change in National Institutes of Health Stroke Scale Score From Baseline to 24 Hours
Change in the National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours. The NIHSS ranges from 0 to 42, with higher scores indicating more severe neurological impairment.
Measured: Baseline and 24 hours after randomization
Change in National Institutes of Health Stroke Scale Score From Baseline to Day 7
Change in NIHSS score from baseline to day 7. The NIHSS ranges from 0 to 42, with higher scores indicating more severe neurological impairment.
Measured: Baseline and 7 days after randomization
Proportion of Participants With Early Neurological Improvement at 24 Hours
The proportion of participants whose NIHSS score decreases by at least 4 points from baseline or reaches 0-1 at 24 hours.
Measured: 24 hours after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Jun 2030 (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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 826 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Lou, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Min Lou, PhD, MD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901842
- Sponsor's protocol ID
- RAISE-AI
- Acronym
- RAISE-AI
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Recombinant Human Prourokinase for Extended-Window Acute Ischemic Stroke Selected by NCCT-Based Artificial Intelligence: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07901842
- Acronym / sponsor ID
- RAISE-AI / RAISE-AI
- Conditions
- Acute Ischemic Stroke
- Keywords
- Extended-Window Intravenous Thrombolysis, Recombinant Human Prourokinase, Noncontrast Computed Tomography, Artificial Intelligence, Tissue-Window Selection, Perfusion Mismatch
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 826 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 28 Oct 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.
This multicenter, prospective, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of intravenous recombinant human prourokinase (rhPro-UK) in patients with acute ischemic stroke treated more than 4.5 hours and up to 24 hours after stroke onset, selected using a noncontrast computed tomography-based artificial intelligence (CT-AI) tissue-window algorithm.
A total of 826 participants will be randomly assigned in a 1:1 ratio to receive intravenous rhPro-UK or matching placebo, in addition to guideline-recommended standard stroke care.
The primary outcome is the proportion of participants achieving a modified Rankin Scale (mRS) score of 0-1 at 90 ± 7 days. Secondary outcomes include functional outcomes, changes in neurological deficits, early neurological improvement at 24 hours and 7 days, and tissue reperfusion at 24-48 hours. Safety outcomes include symptomatic intracranial hemorrhage, parenchymal hematoma, all-cause mortality, and serious systemic bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant Human Prourokinase Group | Experimental | Drug: Recombinant Human Prourokinase for Injection (rhPro-UK)Participants will receive intravenous recombinant human prourokinase (rhPro-UK), 35 mg, in addition to guideline-recommended standard stroke care. |
| Matching Placebo Group | Placebo comparator | Drug: Matching Placebo for Recombinant Human ProurokinaseParticipants will receive matching intravenous placebo in addition to the same guideline-recommended standard stroke care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years.
- Clinically diagnosed acute ischemic stroke.
- Time from stroke onset to randomization >4.5 hours and ≤24 hours. For patients with unknown onset time or wake-up stroke, the estimated onset time will be defined as the midpoint between the last known well time and symptom discovery time.
- Baseline National Institutes of Health Stroke Scale (NIHSS) score of 4-25.
- Pre-stroke modified Rankin Scale (mRS) score of 0-1.
Key exclusion criteria (16 listed)
- Baseline CT showing intracranial hemorrhage, subarachnoid hemorrhage, brain tumor, brain abscess, or other non-ischemic lesions.
- Baseline CT showing an extensive infarction, severe cerebral edema, or mass effect, or the investigator determines that the risks of intravenous thrombolysis substantially outweigh the potential benefits.
- Contraindications specified in the prescribing information for recombinant human prourokinase for injection or current intravenous thrombolysis guidelines, other than the extended treatment time window specifically evaluated in this trial, including but not limited to:
- Pregnancy, breastfeeding, or unwillingness to use effective contraception during the study.
- Inadequate NCCT image quality for CT-AI analysis or inability of the AI model to generate valid outputs.
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 Prourokinase for Injection (rhPro-UK)A total dose of 35 mg will be administered intravenously. The initial 15 mg dissolved in 10 mL solution will be administered by intravenous bolus over 3 minutes, followed by 20 mg dissolved in 90 mL solution administered by intravenous infusion over 30 minutes. | Drug | Recombinant Human Prourokinase Group |
| Matching Placebo for Recombinant Human ProurokinaseMatching placebo will be administered intravenously using the same administration volumes, route, and durations as the active study drug to maintain blinding. | Drug | Matching Placebo Group |
Primary outcome
Proportion of Participants With a Modified Rankin Scale Score of 0-1 at 90 Days
Time frame: 90 ± 7 days after randomization
The proportion of participants achieving a modified Rankin Scale (mRS) score of 0 or 1. The mRS ranges from 0 (no symptoms) to 6 (death), with lower scores indicating better functional outcomes.
6 secondary outcomes
Ordinal Distribution of Modified Rankin Scale Scores at 90 Days
Time frame: 90 ± 7 days after randomization
Proportion of Participants With a Modified Rankin Scale Score of 0-2 at 90 Days
Time frame: 90 ± 7 days after randomization
Proportion of Participants With a Modified Rankin Scale Score of 0-3 at 90 Days
Time frame: 90 ± 7 days after randomization
Change in National Institutes of Health Stroke Scale Score From Baseline to 24 Hours
Time frame: Baseline and 24 hours after randomization
Change in National Institutes of Health Stroke Scale Score From Baseline to Day 7
Time frame: Baseline and 7 days after randomization
Proportion of Participants With Early Neurological Improvement at 24 Hours
Time frame: 24 hours after randomization
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 28 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Min Lou, PhD, MD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant Human Prourokinase for Injection (rhPro-UK) in people with Acute Ischemic Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 11 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 28 Oct 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Min Lou, PhD, MD (+8613958007213, lm99@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With a Modified Rankin Scale Score of 0-1 at 90 Days (time frame: 90 ± 7 days after randomization). 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 28 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.