About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Urinary kallidinogenase for injection
DrugUrinary kallidinogenase 0.15PNA once daily for 7 days.
Guideline-prescribed medical therapy
Other interventionGuideline-prescribed medical therapy
Treatment groups
Trial outcomes
Primary outcomes
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days
Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.
Secondary outcomes
National Institute of Health Stroke Scale (NIHSS) at 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.
Including recurrent and new ischemic stroke.
Adverse events occurring in the course of the treatment.
Including all adverse events, severe adverse events and urinary kallidinogenase related adverse events.
Sponsors and contacts
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Yi Yang
Lead sponsor
The First Hospital of Jilin University
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options: