Pro-urokinase for Extended-Window Posterior Circulation Stroke
Key facts
- Where
- Zhengzhou, ChinaSee the site
- Phase
- Phase 3
Where in China
- Department of Neurology, the First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The First Affiliated Hospital of Zhengzhou University
- Trial code
- NCT07617870
- Record updated
- 1 June 2026
- Original description
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.Read full original descriptionShow less
Pro-urokinase for Reperfusion in Acute pOsterior Circulation ischeMIc Stroke in the Extended Window (the PROMISE Trail): A Randomized, Double-blind, Baseline Treatment-controlled Study
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.
Inclusion: 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.
Exclusion: Intracranial or spinal cord surgery within 3 months; Heparin therapy within 24 hours; Oral anticoagulation therapy; Major surgery within 1 month; Gastrointestinal or urinary tract hemorrhage within the previous 30 days; Participation in other interventional clinical trials within the previous 3 months; Subarachnoid or intracranial hemorrhage; History of intracranial hemorrhage; Active internal hemorrhage; Neurological deficit after epileptic seizures; Myocardial infarction within 3 months; Allergy to study drugs; Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study; platelet count of <100000/mm3; Oral warfarin is being taken and INR>1.6 or APTT abnormal; Blood glucose < 50 mg/dl (2.7mmol/L); 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; Intracranial tumor, arteriovenous malformation or aneurysm; Aortic arch dissection; Systolic pressure≥185 mmHg or diastolic pressure≥110 mmHg; Pregnancy; Unlikely to adhere to the trial protocol or follow-up.