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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urinary Kallidinogenase group | Experimental | Patients are treated with urinary kallidinogenase and guideline-prescribed basic medical therapy. |
|
| Control group | Other | Patients are only treated with guideline-prescribed basic medical therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urinary kallidinogenase for injection | Drug | Urinary kallidinogenase 0.15PNA once daily for 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7days |
| Incidence of ischemic stroke within 90 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Yang, MD,PhD | Contact | 13756661217 | 0086 | doctoryangyi@163.com |
| Zhenni Guo, MD,PhD | Contact | 18186872986 | 0086 | zhen1ni2@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Yang, MD,PhD | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Hospital of Jilin University | Changchun | Jilin | 130000 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Guideline-prescribed medical therapy | Other | Guideline-prescribed medical therapy |
|
Including recurrent and new ischemic stroke.
| 0-90days |
| Adverse events occurring in the course of the treatment. | Including all adverse events, severe adverse events and urinary kallidinogenase related adverse events. | 0-7days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |