Safety and Efficacy of Urinary Kallidinogenase for Large Artery Atherosclerosis Acute Ischemic Stroke
NCT ID: NCT06137300
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
986 participants
INTERVENTIONAL
2024-03-15
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Urinary Kallidinogenase group
Patients are treated with urinary kallidinogenase and guideline-prescribed basic medical therapy.
Urinary kallidinogenase for injection
Urinary kallidinogenase 0.15PNA once daily for 7 days.
Control group
Patients are only treated with guideline-prescribed basic medical therapy.
Guideline-prescribed medical therapy
Guideline-prescribed medical therapy
Interventions
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Urinary kallidinogenase for injection
Urinary kallidinogenase 0.15PNA once daily for 7 days.
Guideline-prescribed medical therapy
Guideline-prescribed medical therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Yi Yang
OTHER
Responsible Party
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Yi Yang
Associated Dean of the First Hospital of Jilin University
Principal Investigators
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Yi Yang, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
The First Hospital of Jilin University
Locations
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First Hospital of Jilin University
Changchun, Jilin, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TK-LAA
Identifier Type: -
Identifier Source: org_study_id
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