Chinese Assessment for Vinpocetine In Neurology (CAVIN)
This study has been completed.
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Weiwei Zhang, Shanghai Rxmidas Pharmaceuticals Co. Ltd.
First received: July 19, 2011
Last updated: August 14, 2013
Last verified: August 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.
||Observational Model: Case Control
Time Perspective: Prospective
||The Investigation of Vinpocetine (Cavinton) for Treatment of Acute Cerebral Infarction, an Open, Multicenter, Randomized, Control Study
Primary Outcome Measures:
- Mini-Mental State Examination (MMSE)and Modified Rankin Scale [ Time Frame: May 2010 - Feb. 2013 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Barthel index and NIHSS [ Time Frame: May. 2010 - Feb. 2013 ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| 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.
|Ages Eligible for Study:
||40 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Totally 610 subjects were recruited, 469 in test group and 141 in control group.
- Male or female, age 40-80
- The onset of the infarction between 48 hours and 1 month
- CT / MRI results show cerebral infarction with deficit of neurological function.
- CT or MRI confirms no intracranial hemorrhage
- NIHSS score ≥ 3
- The subject agree to sign the informed consent form
- Evidence of acute or chronic intracranial hemorrhage, subarachnoid hemorrhage, intracranial arteriovenous malformation, aneurysm or neoplasm based on CT / MRI examination
- NIHSS score ≥ 17
- Coma patient
- Existed disorders or conditions that would interfere neurological assessments (eg. dementia, psychiatric disorder, etc.)
- Intracranial tumor, arteriovenous malformation, aneurysm, or intracranial surgery
- Active peptic ulcer disease
- Complicated with severe hepatic and renal disorder (ALT, AST 3.0 times higher than normal value; BUN or Cr more than 1.5 times the normal value) and severe disorder in hematopoietic system and endocrine system.
- Bleeding tendency or blood disease
- Plan to perform operation and carotid angioplasty
- With severe congestive heart failure or acute myocardial infarction
- Participate in other clinical trials at the same time, or withdrawal within 3 months
- Allergic or contraindicated to vinpocetine or other treatment medication
- Investigator think the subject is not suitable to participate in this trial
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01400035
|Beijing, China, 100700 |
Shanghai Rxmidas Pharmaceuticals Co. Ltd.
Gedeon Richter Ltd.
||Weiwei Zhang, MD
||PLA.The Military General Hospital of Beijing
||Weiwei Zhang, Director of Neurology Department, Shanghai Rxmidas Pharmaceuticals Co. Ltd.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 19, 2011
||August 14, 2013
||China: Food and Drug Administration
Keywords provided by Shanghai Rxmidas Pharmaceuticals Co. Ltd.:
acute cerebral infarction, Vinpocetine
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 27, 2016
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs