CompletedPhase 3

ProUrokinase for Mild Ischemic Cerebrovascular Events (PUMICE)

China1,446 participantsStarted 2022-11-15

Plain-language summary

The purpose of this study is to investigate the safety and efficacy of rhPro-UK (35mg) versus standard medical treatment in acute mild ischemic stroke within 4.5 hours of symptom onset.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥18 years, any gender;
✓. Acute ischemic stroke symptom onset within 4.5 hours prior to enrollment; onset time refers to 'last-seen normal time';
✓. Pre-stroke mRS score≤ 1;
✓. Baseline NIHSS ≤ 5 (both included);
✓. Written informed consent from patients or their legally authorized representatives

Exclusion criteria

✕. Rapidly improving symptoms at the discretion of the investigator;
✕. Intended to proceed to endovascular treatment during 90 days (including mechanical thrombectomy, stent insertion or balloon expansion);
✕. Allergy to rhPro-UK and it's components (human albumin, mannitol);
✕. NIHSS consciousness score 1a \>2, or epileptic seizure, hemiplegia after seizures (Todd's palsy) or combined with other nervous/mental illness unable to cooperate or unwilling to cooperate;
✕. Persistent blood pressure elevation (systolic ≥180 mmHg or diastolic ≥100 mmHg), despite blood pressure lowering treatment;
✕. Blood glucose \<2.8 or \>22.2 mmol/L (point of care glucose testing is acceptable);
✕. Active internal bleeding or at high risk of bleeding, e.g.: Major surgery, trauma or gastrointestinal or urinary tract haemorrhage within the previous 21 days, or arterial puncture at a non-compressible site within the previous 7 days;
✕. Any known impairment in coagulation due to comorbid disease or anticoagulant use. If on warfarin, then INR \>1.7 or prothrombin time \>15 seconds; if use of any direct thrombin inhibitors or direct factor Xa inhibitors or new oral anticoagulants (NOAC) during the last 48 hours unless reversal of effect can be achieved with a reversal agent (by idarucizumab) or sensitivity laboratory test values greater than the upper limit of normal (eg, activated partial thromboplastin time (aPTT), international normalized ratio (INR), platelet count, thrombin time (TT), or appropriate factor Xa activity assay); if on any full dose heparin/heparinoid during the last 24 hours or with an elevated aPTT greater than the upper limit of normal;

What they're measuring

The modified Rankin Scale score (mRS) ≤ 1 at 90 days

Timeframe: 90 days

Trial details

NCT IDNCT05507645

SponsorBeijing Tiantan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-26

View on ClinicalTrials.gov More Ischemic Stroke trials