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Using placebo as control, The purpose of this study is to evaluate the efficacy and safety of methanesulfonic acid cinepazide injection to relieve disabled degree of acute cerebral infarction patients, and explore the best safe and effective dose as well as dose method.
The study will enroll 288 acute cerebral infarction patients. Patients will be assigned randomly to receive either Methanesulfonic acid cinepazide injection or placebo treatment. All patient in the study will receive standard of care treatment and clinical, diagnostic, laboratory, safety, and follow-up evaluations. Follow-up evaluations, including National Institute of Health stroke scale(NIHSS), Barthel index score and modified Rankin scale assessments, will be done periodically until 90 days after onset. The degree of disabled improved will be a primary measure of drug effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cinepazide, Stroke, Injection | Experimental | Test drug:Methanesulfonic acid cinepazide injection(5ml/125mg) |
|
| palcebo,Stroke,Injection | Placebo Comparator | Placebo:simulation agent of Methanesulfonic acid cinepazide injection(5ml sterile water for injection) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cinepazide | Drug | 2 branches of Methanesulfonic acid cinepazide injection were matched into 250 ml 0.9% sodium chloride injection, iv gtt, speed is 100ml/h, once per day. 1 branch of simulation agent of Methanesulfonic acid cinepazide injection was matched into 250 ml 0.9% sodium chloride injection, iv gtt, speed is 100ml/h, once per day. |
| Measure | Description | Time Frame |
|---|---|---|
| modified Rankin scale | 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| Barthel index | 3 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang Zhao, Doctor | Contact | zhaogang@fmmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Gang Zhao, Doctor | Xijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Xi'an | Shaanxi | 710032 | 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 |
|---|---|
| C026896 | cinepazide |
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|
| placebo | Drug | 2 branches of simulation agent of Methanesulfonic acid cinepazide injection were matched into 250 ml 0.9% sodium chloride injection, iv gtt, speed is 100ml/h, once per day. 1 branch of simulation agent of Methanesulfonic acid cinepazide injection were matched into 250 ml 0.9% sodium chloride injection, iv gtt, speed is 100ml/h, once per day. |
|
|
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |