Pro-urokinase for Extended-Window Posterior Circulation Stroke

NCT07617870 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: PROMISE-001
• Study Type: interventional
• Target: 586
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate whether, in patients with imaging-confirmed acute ischemic stroke of the posterior circulation presenting within 4.5-24 hours after symptom onset and not scheduled for endovascular thrombectomy, intravenous thrombolysis with recombinant human prourokinase (rhPro-UK), compared with standard medical treatment, can achieve superior 90-day functional outcomes with a higher level of safety.

Conditions

Acute Ischemic Stroke

Keywords

Recombinant human prourokinase (rhPro-UK); Posterior circulation ischemic stroke; Extended-window thrombolysis; Intravenous thrombolytic therapy

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale (mRS)

  Proportion of subjects of excellent outcome defined as mRS (0-1) at 90 ± 7 days.

  90 ± 7 days]

Secondary Outcomes (6)

• Modified Rankin Scale (mRS)

  90 ± 7 days

• Modified Rankin Scale (mRS)

  90 ± 7 days

• National Institutes of Health Stroke Scale (NIHSS)

  24 hours and 7 days

• Barthel (BI)

  90 ± 7 days

• EuroQol 5-Dimension (EQ-5D)

  90 ± 7 days

Other Outcomes (4)

• Symptomatic intracranial hemorrhage (sICH)

  36 hours

• Death

  90 days

• Systemic bleeding

  90 days

Study Arms (2)

rhPro-UK group

EXPERIMENTAL

On Day 1 after randomization, patients will receive intravenous rhPro-UK plus aspirin placebo (300 mg). From day 2 to day 90, patients will receive standard care according to the Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke (2023).

Drug: rhPro-UK; Drug: placebo

Control group

ACTIVE COMPARATOR

On Day 1 after randomization, patients will receive rhPro-UK placebo plus oral aspirin (300 mg). From day 2 to day 90, patients will receive standard care according to the Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke (2023).

Drug: Aspirin; Drug: Placebo

Interventions

rhPro-UK DRUG

rhPro-UK (5 mg/vial), to maximum of 35mg

rhPro-UK group

Placebo DRUG

Asprin (placebo)

rhPro-UK group

Aspirin DRUG

Asprin (300mg)

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years;
• AIS with symptom onset 4.5-9 hours before enrollment, including wake-up stroke and unwitnessed stroke (onset time defined as when symptoms were first noticed);
• Imaging criteria:
• DWI-FLAIR mismatch: visible lesion on DWI with no marked visible lesion on FLAIR;
• DWI infarct core not exceeding one-third of the middle cerebral artery territory, one-half of the anterior cerebral artery territory, or one-half of the posterior cerebral artery territory;
• NIHSS score 4-25;
• First-ever stroke or previous stroke without significant disability (pre-stroke mRS ≤ 1);
• Signed informed consent from the patient or legally authorized representative.

You may not qualify if:

• Planned endovascular treatment;
• Contradictory to MRI examination;
• MRI image not qualified for evaluation;
• Serious neurological deficits before onset (mRS≥2);
• Obvious head injuries or strokes within 3 months;
• Subarachnoid or intracranial hemorrhage;
• History of intracranial hemorrhage;
• Intracranial tumor, arteriovenous malformation or aneurysm;
• Intracranial or spinal cord surgery within 3 months;
• Active internal hemorrhage;
• platelet count of \<100000/mm3;
• Aortic arch dissection;
• Heparin therapy within 24 hours;
• Oral warfarin is being taken and INR\>1.6 or APTT abnormal;
• Oral anticoagulation therapy;

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

Department of Neurology, the First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Bo Song, MD

CONTACT

+86-371-66278068; fccsongb@zzu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician、Professor

Model Details: Experimental group: On Day 1 after randomization, recombinant human prourokinase (rhPro-UK) plus placebo for aspirin (300 mg). On Day 2, standard treatment as recommended by the Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke (2023). Control group: On Day 1 after randomization, rhPro-UK placebo plus aspirin (300 mg). On Day 2, standard treatment as recommended by the Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke (2023).

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 1, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

CN (1)