rhPro-UK before endovascular stroke treatment in the extended window

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter phase III randomized, double-blind, placebo-controlled trial evaluating intravenous recombinant human prourokinase (rhPro-UK) added before endovascular thrombectomy for large vessel occlusion stroke 4.5 to 24 hours after last known well. Participants receive a 35 mg total dose (15 mg IV push then 20 mg IV infusion) or placebo, with all undergoing thrombectomy. Primary outcome is functional independence (mRS 0–2) at 90 days; secondary outcomes include reperfusion metrics, infarct volume, and safety outcomes such as symptomatic intracranial hemorrhage and 90-day mortality. Safety is monitored by independent adjudication, with centralized blinded outcome assessment and intention-to-treat analysis. A total of about 820 participants are planned to achieve 80% power to detect a 10% absolute improvement in functional independence.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years;
2. Acute ischemic stroke presenting within 4.5-24 hours of last known well;
3. No significant pre-stroke functional disability: for age \<80 years, pre-stroke modified Rankin scale (mRS) ≤2; for age ≥80 years, prestroke mRS ≤1;
4. Baseline NIHSS score ≥6;
5. Imaging criteria of BOTH:

1\. Occlusion on CTA/MRA in one of the following vessels: M1/M2 segment of middle cerebral artery, A1 segment of anterior cerebral artery, V4 segment of vertebral artery, basilar artery, or P1 segment of posterior cerebral artery. For A1, or P1 occlusions, vessel diameter must be ≥0.75 mm; 2. For anterior circulation occlusion: CTP/MRP demonstrating mismatch ratio ≥1.8, absolute mismatch volume ≥15 mL, and ischemic core volume \<70 mL; OR have a mismatch between the presence of an abnormal signal on MRI diffusion-weighted imaging and no visible signal change on FLAIR. For posterior circulation occlusion: pc-ASPECTS score ≥6.

6\. Plan to received endovascular thrombectomy; 7. The patient or their legal representative provides written informed consent.

Exclusion Criteria:

1. Intracranial hemorrhage confirmed by CT/MRI;
2. Onset accompanied by epileptic seizures, resulting in questionable stroke diagnosis and inability to obtain an accurate baseline NIHSS score;
3. Women who are pregnant or breastfeeding, or have a positive serum β-HCG test upon admission;
4. Already received intravenous thrombolytic after index stroke;
5. History of prior intracranial hemorrhage, including cerebral parenchymal hemorrhage, subarachnoid hemorrhage, and subdural/extradural hematoma;
6. Active bleeding or bleeding tendency, such as gastrointestinal bleeding, urinary tract bleeding, retinal hemorrhage, etc., or presence of coagulation dysfunction;
7. History of major recent surgery or trauma, such as intracranial or spinal surgery within the past 3 months, major surgery within the past 2 weeks, or severe head trauma within the past 3 weeks;
8. Baseline blood glucose \<2.8 mmol/L or \>22.2 mmol/L;
9. Received low molecular weight heparin within 24 hours, or oral anticoagulants with an International Normalized Ratio (INR) \>1.7, or thrombin inhibitors within 48 hours, among others;
10. Arterial tortuosity or other vascular anomalies precluding endovascular access to target vessel;
11. Pre-existing neurological/psychiatric disorders interfering with neurological assessment;
12. Space-occupying intracranial tumors (except for small meningiomas);
13. Intracranial aneurysm or arteriovenous malformation;
14. Terminal illness with life expectancy \<6 months;
15. Concurrent participation in other investigation clinical trials;
16. Presence of other conditions deemed by the investigator as unsuitable for participation in the study.

Where it's running

• The First Hospital of Lanzhou University
  Lanzhou, Gansu, China Recruiting
• The Third Hospital of Hebei Medical University
  Shijiazhuang, Hebei, China Recruiting
• Henan Provincial People's Hospital
  Zhengzhou, Henan, China Recruiting
• Loudi Central Hospital
  Loudi, Hunan, China Recruiting
• The Second Hospital of Dalian Medical University
  Dalian, Liaoning, China Recruiting
• Qinghai Provincial People's Hospital
  Xining, Qinghai, China Recruiting

Study contacts

• Study coordinator: Fude Liu, MD
• Email: liufude101@163.com
• Phone: 18161823657

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.