Anterior circulation acute ischemic stroke
Conditions
Interventions
Intervention group:Urinary Kallidinogenase Combined with Clinical Routine Treatment
Sponsors
Beijing Tsinghua Changgung Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 18 to 80 years of age; 2. Diagnosis of anterior circulation acute ischemic stroke; 3. Within 48 hours of symptoms onset; 4. modifed Rankin Scale (mRS) score=1 before this event; 5. 5=NIHSS=20 at screening; 6. The availability of informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have already or are going to reveive intravenous thrombolytic/mechanical thrombectomy therapy after onset; 2. Patients with severe consciousness disorder, NIHSS 1a consciousness level score=2; 3. Patients with limited limb mobility such as fractures and claudication upon admission; 4. Patients who have already or are going to reveive Edaravone injection, Edaravone and Dexborneol concentrated solution for injection, Butylphthalide and sodium chloride injection or Butylphthalide soft capsules after onset; 5. Hypotensive (systolic blood pressure <90 mmHg or diastolic blood pressure<60 mmHg) on admission; 6. History of severe drug or food allergy, allergy or intolerance to Human Urinary Kallidinogenase; 7. Patients who have been on angiotensin-converting enzyme inhibitor (ACEI) drugs and within 5 half-lives (according to the specific drug instructions) before initiate HUK treatment; 8. Pregnancy, lactation, or planned pregnancy within 90 days; 9. Patients with severe renal failure or impairment (eGFR<30ml/min/1.73m2) at screening; 10. Severe hepatic dysfunction, elevation of ALT or AST (more than 2.5 times of upper limit of normal value), other liver diseases such as acute and chronic hepatitis, cirrhosis, etc; 11. Patients with heart failure (NYHA class III or IV), unstable angina pectoris, acute myocardial infarction, severe arrhythmia, and degree II and III cardiac conduction obstruction within 6 months prior to randomization; 12. Heavy drinking in the three months before screening, drinking=5 standard drinks per day (1 standard drink is equivalent to120ml wine, 360ml beer or 45ml liquor); 13. Drug Abuse or addiction in the past year; 14. Patients with a malignant tumor, severe systemic diseases, or estimated survival time <90 days; 15. Patients with severe mental disorders or dementia unable to complete the informed consent and follow-up; 16. Have participated in another interventional clinical study within 30 days before randomization or are participating in another interventional clinical study; 17. Other cases unsuitable for this clinical study assessed by researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with modified Rankin Scale (mRS) 0-2 at day 90; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of Tmax>6s volume on CTP from baseline to 5 days after treatment;Change of rCBF in Tmax>6s area on CTP from baseline to 5 days after treatment;Ordinal distribution of modified Rankin Scale (mRS) at day 90;The proportion of patients with modified Rankin Scale (mRS) 0-1 at day 90;Change of National Institute of Health stroke Scale (NIHSS) score from baseline to 5 days after treatment;Change of National Institute of Health stroke scale (NIHSS) score from baseline to 10 days after treatment; | — |
Countries
China
Contacts
Public ContactJian Wu\Zunjing Liu
Beijing Tsinghua Changgung Hospital\Peking University People's Hospital
Outcome results
None listed