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In order to reevaluate safety and efficacy of human urinary kallikrein in treating acute cerebral infarction ,a multi-center, open label , single group study was designed. Expect to enroll 60 sites and 2186 subjects. Subjects will receive kallikrein treatment according to real clinical practice (suggest above 14days treatment) and 90 days follow up
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| kallikrein group | Experimental | Subjects receive kallikrein treatment according to real clinical practice (suggest above 14days treatment),0.15 peptide nucleic acids(PNA), once a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| kallikrein | Drug | Using kallikrein |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | From enrolled to the day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral infarction on the National Institute of Health stroke scale | The day 8,15 and 22 after enrolled | |
| Recurrence rate of acute cerebral infarction | From enrolled to the day 90 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liying Cui, Doctor | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China | ||
| NO.2 Hospital XiaMen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28265861 | Derived | Ni J, Qu J, Yao M, Zhang Z, Zhong X, Cui L; RESK investigators. Re-evaluate the Efficacy and Safety of Human Urinary Kallidinogenase (RESK): Protocol for an Open-Label, Single-Arm, Multicenter Phase IV Trial for the Treatment of Acute Ischemic Stroke in Chinese Patients. Transl Stroke Res. 2017 Aug;8(4):341-346. doi: 10.1007/s12975-017-0527-5. Epub 2017 Mar 6. |
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| ID | Term |
|---|---|
| D002544 | Cerebral Infarction |
| ID | Term |
|---|---|
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D007610 | Kallikreins |
| D020840 | Tissue Kallikreins |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Activities of daily living on the Barthel Index |
| The day 15,22 and 90 after enrolled |
| Patients body status on the Modified Rankin Scale | The day 15, 22 and 90 after enrolled |
| EQ-5D-3L score | The day 15, 22 and 90 after enrolled |
| Evaluation of pharmaceutical economics | The day 15, 22 and 90 after enrolled |
| Xiamen |
| Fujian |
| 361000 |
| China |
| HanDan Central Hospital | Handan | Hebei | 056001 | China |
| Harrison International Peace Hospital | Hengshui | Hebei | 053000 | China |
| Chenzhou NO.1 People's Hospital | Chenzhou | Hunan | 423000 | China |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | 212000 | China |
| The Fourth Affiliated hospital of Zhejiang University School of Medicine | Yiwu | Zhejiang | 322000 | China |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020521 | Stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
| D014408 | Biomarkers, Tumor |
| D015415 | Biomarkers |