NCT06211712Recruiting
Efficacy and Safety of Human Urinary Kallidinogenase Combined With Endovascular Therapy in Acute Ischemic Stroke With Large Vessel Occlusion
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
Source: ClinicalTrials.gov · Last updated 4 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 28 Dec 2023
- Start date
- 17 Apr 2024
- Primary completion date
- Jun 2025
- Lead sponsor
- Huashan Hospital
- Diseases
- Stroke
- NCT number
- NCT06211712
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 17 Apr 2024 to the primary completion date, Jun 2025
- 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
- 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.
Other illness
- 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.).
Other
- Poor compliance and cannot fully follow the study protocol.
- Pregnancy or lactation.
Who the study is looking for
- 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).
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 |
|---|---|---|---|
| Huashan Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.