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

Sponsor

Yi Yang (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06137300

Collaborator

(none)

986

Enrollment

Location

Arms

Anticipated Duration (Months)

20.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke	Drug: Urinary kallidinogenase for injection Other: Guideline-prescribed medical therapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

986 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2026

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Urinary Kallidinogenase group Patients are treated with urinary kallidinogenase and guideline-prescribed basic medical therapy.	Drug: Urinary kallidinogenase for injection Urinary kallidinogenase 0.15PNA once daily for 7 days. Other Names: Guideline-prescribed medical therapy
Other: Control group Patients are only treated with guideline-prescribed basic medical therapy.	Other: Guideline-prescribed medical therapy Guideline-prescribed medical therapy

Arm

Intervention/Treatment

Experimental: Urinary Kallidinogenase group

Patients are treated with urinary kallidinogenase and guideline-prescribed basic medical therapy.

Drug: Urinary kallidinogenase for injection

Urinary kallidinogenase 0.15PNA once daily for 7 days.

Other Names:

Guideline-prescribed medical therapy

Other: Control group

Patients are only treated with guideline-prescribed basic medical therapy.

Other: Guideline-prescribed medical therapy

Guideline-prescribed medical therapy

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.