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Acute Ischemic StrokePhase 2NCT07550296

Repeated Intravenous Thrombolysis for Ischemic Stroke With Medium to Large Vessel Occlusion Presenting Within 4.5 Hours of Onset With Prourokinase

A Phase 2 study testing prourokinase in people with Acute Ischemic Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Ischemic cerebrovascular disease is a common neurological disorder with high incidence, mortality, and disability. Early reperfusion to salvage the ischemic penumbra is the cornerstone of acute ischemic stroke (AIS) treatment. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
prourokinase
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
1 siteChina
Study dates
6 May 2026to 30 Dec 2027
Phase
Phase 2
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 year;
  • Acute ischemic stroke presumably caused by large or medium vessel occlusion within 4.5 hours of onset, having received intravenous thrombolysis of prourokinase, and with no planned thrombectomy;
  • Measurable neurological deficit before the first intravenous thrombolysis, with NIHSS ≥ 4;
  • Baseline pc-ASPECTS/ASPECTS ≥ 6, and for posterior circulation infarction, a Pontine-Midbrain Index ≤ 2 (assessed by CT or DWI);
  • No significant clinical improvement (reduction in NIHSS ≤ 2) or neurological deterioration after initial improvement at 1 hour after the first thrombolysis;
  • Follow-up imaging (CTA or MRA) at 1 hour after the first thrombolysis rules out intracranial hemorrhage and confirms the presence of large or medium vessel occlusion (internal carotid artery, M1-M3 segments of the middle cerebral artery, A1-A3 segments of the anterior cerebral artery, P1-P3 segments of the posterior cerebral artery, basilar artery or V4 segment of the vertebral artery, PICA, AICA, or SCA);
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  • The second intravenous thrombolysis can be administered within 6 hours of onset;
  • First stroke onset or past stroke without obvious neurological deficit (mRS≤1);
  • Signed informed consent.

Who cannot join

  • Planed for endovascular treatment;
  • Significant white matter hyperintensities (Fazekas score 3);
  • Any coagulation abnormality before the first thrombolysis, including INR > 1.5;
  • Receipt of dual antiplatelet therapy within 24 hours prior to thrombolysis.；
  • Pregnancy；
  • Allergy to the investigational drug(s)；
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  • Comorbidity with other serious diseases;
  • Participating in other clinical trials within 3 months;
  • Patients not suitable for the study considered by researcher.

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, 1 recruiting

  • Hui-Sheng Chen

    Shenyang, None Selected, 110016

    Yu Cui, 02428897517, cuiyu.spu@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: Repeated Intravenous Thrombolysis for Ischemic Stroke With Medium to Large Vessel Occlusion Presenting Within 4.5 Hours of Onset With Prourokinase (RITIS-PUK): a Prospective, Randomized, Open Label, Blinded Assessment of Outcome, and Multi-center Study

Ischemic cerebrovascular disease is a common neurological disorder with high incidence, mortality, and disability. Early reperfusion to salvage the ischemic penumbra is the cornerstone of acute ischemic stroke (AIS) treatment. Current reperfusion strategies include intravenous thrombolysis (IVT) and endovascular therapy (EVT). Although alteplase is the first-line thrombolytic agent, its recanalization rate for large vessel occlusion (LVO) is only 10-20%, and for medium vessel occlusion (MeVO), approximately 50% of patients fail to achieve recanalization, leading to poor outcomes. Prourokinase has recently been shown to be non-inferior to alteplase with a better safety profile, and studies suggest that repeated thrombolysis may improve recanalization rates in patients without early clinical improvement after standard IVT. Therefore, this study aims to evaluate the efficacy and safety of an additional intravenous infusion of prourokinase in AIS patients with confirmed medium or large vessel occlusion who show no significant clinical improvement at 1 hour after standard IVT (within 4.5 hours of symptom onset). Patients without early neurological improvement (e.g., <2-point reduction in NIHSS) and persistent vessel occlusion on imaging will receive a second dose of prourokinase. The primary outcomes include 24-hour recanalization rate (by CTA/MRA), 90-day functional outcome (modified Rankin Scale), and safety endpoints (symptomatic intracranial hemorrhage, mortality). The hypothesis is that additional prourokinase following standard IVT in non-improving patients with medium or large vessel occlusion will significantly increase recanalization rates and improve clinical outcomes without an unacceptable increase in symptomatic intracranial hemorrhage.

Being tested
prourokinase
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • prourokinaseDrug

    Intravenous administration of prourokinase (20 mg infused over a 30-minute period)

Study groups in NCT07550296
Study groupRoleWhat they receive
PUK groupExperimentalNot described
Receives: Drug: prourokinase
Control groupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. rate of vessel recanalization

    Measured: 24 (-6/+12) hours

Secondary outcomes (11)

  1. proportion of excellent functional outcome (modified Rankin Scale (mRS) 0-1)

    The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

    Measured: 90±7 days

  2. proportion of favorable functional outcome (modified Rankin Scale (mRS) 0-2)

    The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

    Measured: 90±7 days

  3. ordinal distribution of modified Rankin Scale (mRS)

    The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

    Measured: 90±7 days

  4. occurrence of early neurological improvement (ENI)

    NI is defined as more than 4-point decrease in National Institute of Health stroke scale score; the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome

    Measured: 24 (-6/+12) hours

  5. change in National Institute of Health stroke scale (NIHSS) score

    the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome

    Measured: 24 (-6/+12) hours

  6. change in National Institute of Health stroke scale (NIHSS) score

    the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome

    Measured: 10±2 days

  7. all-cause mortality

    Measured: 10±2 days

  8. occurence of symptomatic intracranial hemorrhage (sICH)

    Measured: 24 (-6/+12) hours

  9. occurence of any intracranial hemorrhage

    Measured: 24 (-6/+12) hours

  10. occurence of major systemic bleeding event

    Measured: 24 (-6/+12) hours

  11. occurence of any bleeding event

    Measured: 24 (-6/+12) hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2026
  2. Study start6 May 2026
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
122 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07550296
Sponsor's protocol ID
Y (2026) 15
Status last verified
Jun 2026
First submitted
19 Apr 2026
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing prourokinase in people with Acute Ischemic Stroke, run by General Hospital of Shenyang Military Region 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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 30 Jun 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

rate of vessel recanalization (time frame: 24 (-6/+12) hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07550296.

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 30 Jun 2026.

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