Clinical trial NCT06137300: Safety and Efficacy of Urinary Kallidinogenase for Large Artery Atherosclerosis Acute Ischemic Stroke
Official title: Safety and Efficacy of Urinary Kallidinogenase for Large Artery Atherosclerosis Acute Ischemic Stroke：a Multicentre, Prospective, Randomised, Open-label, Blinded-Endpoint Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: Acute Ischemic Stroke, Urinary Kallidinogenase
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 986
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days
timeFrame: 90 days
Secondary outcomes:
measure: National Institute of Health Stroke Scale (NIHSS) at 7days.
timeFrame: 7days
measure: Incidence of ischemic stroke within 90 days.
timeFrame: 0-90days
measure: Adverse events occurring in the course of the treatment.
timeFrame: 0-7days
Other outcomes:
Locations:
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Yi Yang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: