Trial Title：The treatment of Vinpocetine（Cavinton）in patients with cerebral infarction, an open, randomized, multi-center control study
1. Objectives Evaluate the efficacy and safety of Vinpocetine（Cavinton）for treatment of cerebral infarction
2. Design Open, randomized, multi-center control study
3. Trial Population:Patients with acute cerebral infarction
4. Number of Subjects 720 patients in test group and 240 patients in control group, totally 960 patients will be recruited.
5. 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.
6. 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
7. Statistical Analysis: SPSS 11.0 will be used to make the data analysis.
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.
- Observation: Case Control
- Perspective: Prospective
- Sampling: Probability Sample
Totally 610 subjects were recruited, 469 in test group and 141 in control group.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Modified Rankin scale (the score difference compared to baseline ≧2)||Jun. 2010 - Jul. 2011||Yes|
|Secondary||Barthel index||Jun. 2010 - Jul. 2011||Yes|
|Primary||Mini-Mental State Examination (MMSE)and Modified Rankin Scale||May 2010 - Feb. 2013||Yes|
|Secondary||Barthel index and NIHSS||May. 2010 - Feb. 2013||Yes|