Chinese Assessment for Vinpocetine In Neurology (CAVIN)
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|ClinicalTrials.gov Identifier: NCT01400035|
Recruitment Status : Completed
First Posted : July 22, 2011
Last Update Posted : August 16, 2013
Trial Title：The treatment of Vinpocetine（Cavinton）in patients with cerebral infarction, an open, randomized, multi-center control study
- Objectives Evaluate the efficacy and safety of Vinpocetine（Cavinton）for treatment of cerebral infarction
- Design Open, randomized, multi-center control study
- Trial Population:Patients with acute cerebral infarction
- Number of Subjects 720 patients in test group and 240 patients in control group, totally 960 patients will be recruited.
Administration Test group: intravenous infusion drip of Vinpocetine 30 mg and Citicoline 0.4g once daily; additionally oral take aspirin 75-100mg or clopidogrel sulfate tablets 75mg once a day.
Control group: intravenous infusion drip of Citicoline 0.4g once daily; additionally oral take aspirin 75-100mg or clopidogrel sulfate tablets 75mg once a day.
- Outcome evaluation 6.1 Primary end points: 6.1.1 Modified Rankin Scale. 6.1.2 Mini-Mental State Examination (MMSE) 6.2 Second end points 6.2.1 Barthel index 6.2.2 NIHSS score 6.2.3 Transcranial Doppler (TCD) examination 6.3 Safety data 6.3.1 Serology, hepatic and renal function examination 6.3.2 Adverse events
- Statistical Analysis: SPSS 11.0 will be used to make the data analysis.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||610 participants|
|Observational Model:||Case Control|
|Official Title:||The Investigation of Vinpocetine (Cavinton) for Treatment of Acute Cerebral Infarction, an Open, Multicenter, Randomized, Control Study|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||May 2013|
test group, control group
Test group: Patients will be given cytidine diphosphate choline 0.4-0.5g, aspirin 75-100mg or Clopidogrel 75mg, intravenous infusion of Cavinton 30mg once a day.
Control group: Patients will be given cytidine diphosphate choline 0.4-0.5g, aspirin 75-100mg or Clopidogrel 75mg once a day.
- Mini-Mental State Examination (MMSE)and Modified Rankin Scale [ Time Frame: May 2010 - Feb. 2013 ]
- Barthel index and NIHSS [ Time Frame: May. 2010 - Feb. 2013 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01400035
|Beijing, China, 100700|
|Principal Investigator:||Weiwei Zhang, MD||PLA.The Military General Hospital of Beijing|