Clinical Trial: Chinese Assessment for Vinpocetine In Neurology

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: The Investigation of Vinpocetine (Cavinton) for Treatment of Acute Cerebral Infarction, an Open, Multicenter, Randomized, Control Study

Brief Summary:

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.

Detailed Summary: 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 [14]. 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.
Sponsor: Shanghai Rxmidas Pharmaceuticals Co. Ltd.

Current Primary Outcome: Mini-Mental State Examination (MMSE)and Modified Rankin Scale [ Time Frame: May 2010 - Feb. 2013 ]

Original Primary Outcome: Modified Rankin scale (the score difference compared to baseline ≧2) [ Time Frame: Jun. 2010 - Jul. 2011 ]

Modified Rankin scale (the score difference compared to baseline ≧ 2) MMSE (the score difference compared to baseline ≧26)


Current Secondary Outcome: Barthel index and NIHSS [ Time Frame: May. 2010 - Feb. 2013 ]

Original Secondary Outcome: Barthel index [ Time Frame: Jun. 2010 - Jul. 2011 ]

  1. Barthel index
  2. NIHSS
  3. Transcranial Doppler sonography (TCD) examination: blood flow rate, frequency spectrum, morphous, pulsatility index, resistant index of middle cerebral artery, anterior cerebral artery, posterior cerebral artery, vertebral artery, basal artery.


Information By: Shanghai Rxmidas Pharmaceuticals Co. Ltd.

Dates:
Date Received: July 19, 2011
Date Started: May 2010
Date Completion:
Last Updated: August 14, 2013
Last Verified: August 2013