Safety and Efficacy of Urinary Kallidinogenase for Large Artery Atherosclerosis Acute Ischemic Stroke

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of urinary kallidinogenase treatment in patients with large artery atherosclerotic acute ischemic stroke.

Detailed Description
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Currently, evidence regarding the safety and efficacy of urinary kallidinogenase treatment in patients with acute ischemic stroke lacks, and few of related studies were large-scale and high-quality. Thus, this study was designed to evaluate the safety and efficacy of urinary kallidinogenase treatment in patients with large artery atherosclerotic acute ischemic stroke.

Official Title
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Safety and Efficacy of Urinary Kallidinogenase for Large Artery Atherosclerosis Acute Ischemic Stroke：a Multicentre, Prospective, Randomised, Open-label, Blinded-Endpoint Trial

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Drug: Urinary kallidinogenase for injection
* Other: Guideline-prescribed medical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years old; Acute anterior circulation large artery atherosclerotic cerebral infarction (according to TOAST classification) within 48h of onset; NIHSS score ≥6, ≤15; Moderate to severe stenosis or occlusion of offending vessels; The mRS Score ≤2 before onset; Subjects or their legal representatives agreed to the treatment and signed the informed consent form. Exclusion Criteria: Transient ischemic attack; Patients who planned or had received emergency reperfusion therapy (including intravenous thrombolysis and emergency thrombectomy); Severe disturbance of consciousness:GCS ≤8; Patients who previously received angiotensin-converting enzyme inhibitor (ACEI) drugs regularly; Refractory hypertension: systolic blood pressure ≥200 mmHg or diastolic blood pressure ≥110 mmHg; hypotension: systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg; Liver dysfunction (ALT/AST >1.5 × upper limit of normal [ULN]), renal dysfunction (Cr >1 × ULN); Coagulopathy (prolonged INR (>1.5) or prolonged APTT (>2 folds); Cardioembolic stroke or high-risk factors of cardioembolic stroke identified by investigators (atrial fibrillation, cardiac mural thrombus, cardiomyopathy, etc.); Special populations such as pregnant and lactating women, patients with life expectancy less than 3 months, or patients unable to complete the study for other reasons; Unwilling to be followed up or poor treatment compliance; Participating in other clinical investigators, or had participated in other clinical investigators within 3 months before enrollment; Other conditions considered by the investigator to be inappropriate for enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Urinary Kallidinogenase group<br>Patients are treated with urinary kallidinogenase and guideline-prescribed basic medical therapy. | Drug: Urinary kallidinogenase for injection<br>* Urinary kallidinogenase 0.15PNA once daily for 7 days.<br>* Other names: Guideline-prescribed medical therapy;|
| Other: Control group<br>Patients are only treated with guideline-prescribed basic medical therapy. | Other: Guideline-prescribed medical therapy<br>* Guideline-prescribed medical therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days | Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Institute of Health Stroke Scale (NIHSS) at 7days. | National Institute of Health stroke Scale (NIHSS) ranged from 0 to 42, a low value represents a better outcome. | 7days | 
| Incidence of ischemic stroke within 90 days. | Including recurrent and new ischemic stroke. | 0-90days | 
| Adverse events occurring in the course of the treatment. | Including all adverse events, severe adverse events and urinary kallidinogenase related adverse events. | 0-7days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Ischemic Stroke, Urinary Kallidinogenase