Repeated intravenous prourokinase for ischemic stroke with medium to large vessel occlusion within 4.5 hours

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 phase II trial evaluates the safety and potential benefit of a second intravenous dose of prourokinase in patients with acute ischemic stroke who have large or medium vessel occlusions and have already received prourokinase but show no major early improvement. Eligible patients arrive within 4.5 hours of onset and have measurable deficits, with imaging confirming occlusion and ruling out hemorrhage after the first treatment. The study will monitor recanalization rates, functional outcomes, and adverse events to determine whether repeat thrombolysis can improve restoration of blood flow and clinical recovery. No planned thrombectomy is required in this protocol, and results will inform whether this approach warrants further investigation in larger trials.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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);
* 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.

Exclusion Criteria:

* 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)；
* Comorbidity with other serious diseases;
* Participating in other clinical trials within 3 months;
* Patients not suitable for the study considered by researcher.

Where it's running

• Hui-Sheng Chen
  Shenyang, None Selected, China Recruiting

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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.