Chinese Assessment for Vinpocetine In Neurology (CAVIN)
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||The Investigation of Vinpocetine (Cavinton) for Treatment of Acute Cerebral Infarction, an Open, Multicenter, Randomized, Control Study|
- Mini-Mental State Examination (MMSE)and Modified Rankin Scale [ Time Frame: May 2010 - Feb. 2013 ] [ Designated as safety issue: Yes ]
- Barthel index and NIHSS [ Time Frame: May. 2010 - Feb. 2013 ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2010|
|Study Completion Date:||May 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
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.
The design of this study is a randomized, open, multi-center and control study. The patients with cerebral infarction are as the study objects. Coronal CT / MRI examination combined with NIHSS and Modified Ranking Scale, MMSE, Barthel index, Transcranial Doppler (TCD) examination are applied to evaluate the Vinpocetine treatment efficacy and safety for cerebral infarction . From ethical side, all patients will receive a conventional therapy, and based on it, the test group will be given intravenous injection of Vinpocetine as add-on treatment. Observation period is 10-14 days, and follow up for 3 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400035
|Beijing, China, 100700|
|Principal Investigator:||Weiwei Zhang, MD||PLA.The Military General Hospital of Beijing|