NCT06211712 Efficacy and Safety of Human Urinary Kallidinogenase Combined With Endovascular Therapy in Acute Ischemic Stroke With Large Vessel Occlusion
| NCT ID | NCT06211712 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Huashan Hospital |
| Condition | Acute Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-04-17 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-04-17 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Participant with acute anterior circulation ischemic stroke receiving endovascular treatment within 24 hours (non-bridged). 2. Age ≥18 years old. 3. The mRS score was 0-1 before onset. 4. ASPECT score of infarction on emergency CT ≥7. 5. Emergency CTA indicating AIS with large vessel occlusion (internal carotid artery, M1 or M2 segment of middle cerebral artery). 6. Emergency CTP or DWI suggesting infarct core body ≥10 mL and \<100 mL, and low perfusion brain tissue volume/ infarct core volume\> 1.2. 7. Participant is willing and able to comply with the study protocol, and sign the informed consent form (patient or surrogate). Exclusion Criteria: 1. Participant with severe heart, liver and kidney dysfunction, coagulation dysfunction, intolerance to surgery, Human Urinary Kallidinogenase allergy, contrast agent allergy or other angiographic contraindications. 2. CT or MRI showed intracranial hemorrhagic diseases (such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.). 3. Participant with previous cerebral hemorrhage, brain tumor, brain trauma or other brain diseases. 4. Taking ACEI antihypertensive drugs regularly and could not stop. 5. Participant with major surgery or severe trauma in the past 2 weeks. 6. Poor compliance and cannot fully follow the study protocol. 7. Pregnancy or lactation.
Contact & Investigator
Qiang Dong, M.D.
PRINCIPAL INVESTIGATOR
Huashan Hospital
Frequently Asked Questions
Who can join the NCT06211712 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06211712 currently recruiting?
Yes, NCT06211712 is actively recruiting participants. Contact the research team at 13701747065@163.com for enrollment information.
Where is the NCT06211712 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06211712 clinical trial?
NCT06211712 is sponsored by Huashan Hospital. The principal investigator is Qiang Dong, M.D. at Huashan Hospital. The trial plans to enroll 120 participants.
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