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

Not Applicable

Not yet recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Other: Guideline-prescribed medical therapy; Drug: Urinary kallidinogenase for injection

• Registration Number: NCT06137300
• Lead Sponsor: Yi Yang

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-11-14
• Study First Posted: 2023-11-18
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-25
• Last Update Posted: 2024-02-28
• Study Start: 2024-03-15
• Primary Completion: 2026-06-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 986

Inclusion Criteria

1. Age ≥18 years old;
2. Acute anterior circulation large artery atherosclerotic cerebral infarction (according to TOAST classification) within 48h of onset; NIHSS score ≥6, ≤15;
3. Moderate to severe stenosis or occlusion of offending vessels;
4. The mRS Score ≤2 before onset;
5. Subjects or their legal representatives agreed to the treatment and signed the informed consent form.

Exclusion Criteria

1. Transient ischemic attack;
2. Patients who planned or had received emergency reperfusion therapy (including intravenous thrombolysis and emergency thrombectomy);
3. Severe disturbance of consciousness:GCS ≤8;
4. Patients who previously received angiotensin-converting enzyme inhibitor (ACEI) drugs regularly;
5. 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;
6. Liver dysfunction (ALT/AST >1.5 × upper limit of normal [ULN]), renal dysfunction (Cr >1 × ULN);
7. Coagulopathy (prolonged INR (>1.5) or prolonged APTT (>2 folds);
8. Cardioembolic stroke or high-risk factors of cardioembolic stroke identified by investigators (atrial fibrillation, cardiac mural thrombus, cardiomyopathy, etc.);
9. 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;
10. Unwilling to be followed up or poor treatment compliance;
11. Participating in other clinical investigators, or had participated in other clinical investigators within 3 months before enrollment;
12. Other conditions considered by the investigator to be inappropriate for enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Guideline-prescribed medical therapy	Patients are only treated with guideline-prescribed basic medical therapy.
Urinary Kallidinogenase group	Urinary kallidinogenase for injection	Patients are treated with urinary kallidinogenase and guideline-prescribed basic medical therapy.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China