Acute Ischemic Stroke
Conditions
Keywords
Acute Ischemic Stroke, Urinary Kallidinogenase
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.
Interventions
Urinary kallidinogenase 0.15PNA once daily for 7 days.
OTHERGuideline-prescribed medical therapy
Guideline-prescribed medical therapy
Sponsors
Yi Yang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactYi Yang, MD,PhD
Backup ContactZhenni Guo, MD,PhD
Outcome results
None listed