Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-29 @ 6:53 AM
Study NCT ID:
NCT06211712
Status:
RECRUITING
Last Update Posted:
2024-12-04
First Post:
2023-12-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Human Urinary Kallidinogenase Combined With Endovascular Therapy in Acute Ischemic Stroke With Large Vessel Occlusion
Sponsor:
Huashan Hospital
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEAL
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.
Detailed Description:
A prospective, randomized, double-blind, placebo-controlled, multi-center study of Human Urinary Kallidinogenase or Placebo, combined with endovascular therapy for AIS patients with large vessel occlusion.
Approximately 120 eligible subjects will be randomized (1:1) to receive one of the following treatments for 10 days:
* Human Urinary Kallidinogenase combined with endovascular therapy (non-bridged)
* Placebo combined with endovascular therapy (non-bridged) Primary efficacy of Human Urinary Kallidinogenase will be evaluated at 90±7 days.
The safety of Human Urinary Kallidinogenase will be evaluated through 90±7 days.
End of study evaluation will occur at day 90±7 or premature discontinuation.
Approximately 120 eligible subjects will be randomized (1:1) to receive one of the following treatments for 10 days:
* Human Urinary Kallidinogenase combined with endovascular therapy (non-bridged)
* Placebo combined with endovascular therapy (non-bridged) Primary efficacy of Human Urinary Kallidinogenase will be evaluated at 90±7 days.
The safety of Human Urinary Kallidinogenase will be evaluated through 90±7 days.
End of study evaluation will occur at day 90±7 or premature discontinuation.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: