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Tests treatment safety and results for Acute Ischemic Stroke
Official title Efficacy and Safety of Human Urinary Kallidinogenase Combined With Endovascular Therapy in Acute Ischemic Stroke With Large Vessel Occlusion
ClinicalTrials.gov ID: NCT06211712
What this study is testing
What is Experimental: Human Urinary Kallidinogenase?
Experimental: Human Urinary Kallidinogenase is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for acute ischemic stroke.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the safety and efficacy of Human Urinary Kallidinogenase combined with endovascular therapy in acute ischemic stroke (AIS) patients with large vessel occlusion.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant with acute anterior circulation ischemic stroke receiving endovascular treatment within 24 hours (non-bridged).
- Age ≥18 years old.
- The mRS score was 0-1 before onset.
- ASPECT score of infarction on emergency CT ≥7.
- Emergency CTA indicating AIS with large vessel occlusion (internal carotid artery, M1 or M2 segment of middle cerebral artery).
You likely can't join if
- Participant with severe heart, liver and kidney dysfunction, coagulation dysfunction, intolerance to surgery, Human Urinary Kallidinogenase allergy...
- CT or MRI showed intracranial hemorrhagic diseases (such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular...
- Participant with previous cerebral hemorrhage, brain tumor, brain trauma or other brain diseases.
- Taking ACEI antihypertensive drugs regularly and could not stop.
- Participant with major surgery or severe trauma in the past 2 weeks.
- Poor compliance and cannot fully follow the study protocol.
See the full eligibility criteria
- Participant with acute anterior circulation ischemic stroke receiving endovascular treatment within 24 hours (non-bridged).
- Age ≥18 years old.
- The mRS score was 0-1 before onset.
- ASPECT score of infarction on emergency CT ≥7.
- Emergency CTA indicating AIS with large vessel occlusion (internal carotid artery, M1 or M2 segment of middle cerebral artery).
- Emergency CTP or DWI suggesting infarct core body ≥10 mL and \ 1.2.
- Participant is willing and able to comply with the study protocol, and sign the informed consent form (patient or surrogate).
- Participant with severe heart, liver and kidney dysfunction, coagulation dysfunction, intolerance to surgery, Human Urinary Kallidinogenase allergy, contrast agent allergy or other angiographic contraindications.
- CT or MRI showed intracranial hemorrhagic diseases (such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.).
- Participant with previous cerebral hemorrhage, brain tumor, brain trauma or other brain diseases.
- Taking ACEI antihypertensive drugs regularly and could not stop.
- Participant with major surgery or severe trauma in the past 2 weeks.
- Poor compliance and cannot fully follow the study protocol.
- Pregnancy or lactation.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.