Status:
NOT_YET_RECRUITING
Safety and Efficacy of Urinary Kallidinogenase for Large Artery Atherosclerosis Acute Ischemic Stroke
Lead Sponsor:
Yi Yang
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
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. T...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
986 Patients enrolled
Trial Details
Trial ID
NCT06137300
Start Date
March 15 2024
End Date
December 31 2027
Last Update
February 28 2024
Active Locations (1)
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1
First Hospital of Jilin University
Changchun, Jilin, China, 130000