NCT07617870Not yet recruitingPhase 3
Pro-urokinase for Extended-Window Posterior Circulation Stroke
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
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 586 (estimated)
- First submitted
- 26 May 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou University
- Diseases
- Stroke
- NCT number
- NCT07617870
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 586
- From 1 Jun 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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;
Lab values
- 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);
Other
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Neurology, the First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.