Tests urinary kallidinogenase with clot-removal treatment for acute ischemic stroke
Tests kallidinogenase alongside endovascular therapy in adults with acute stroke from a large vessel blockage.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Human Urinary Kallidinogenase Combined With Endovascular Therapy in Acute Ischemic Stroke With Large Vessel Occlusion
Key facts
- Where
- Shanghai, ChinaSee the site
Where in China
- Huashan HospitalShanghai, ChinaTaking people
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
- Huashan Hospital
- Trial code
- NCT06211712
- Record updated
- 4 December 2024
- Original description
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.Read full original descriptionShow less
Efficacy and Safety of Human Urinary Kallidinogenase Combined With Endovascular Therapy in Acute Ischemic Stroke With Large Vessel Occlusion: A Prospective, Randomized, Double-blind, Placebo-controlled, Multi-center Study
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.
Inclusion: 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 <100 mL, and low perfusion brain tissue volume/ infarct core volume> 1.2; Participant is willing and able to comply with the study protocol, and sign the informed consent form (patient or surrogate).
Exclusion: 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; 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.); Poor compliance and cannot fully follow the study protocol; Pregnancy or lactation.