Clinical trial NCT01400035: Chinese Assessment for Vinpocetine In Neurology
Official title: The Investigation of Vinpocetine (Cavinton) for Treatment of Acute Cerebral Infarction, an Open, Multicenter, Randomized, Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Infarction
Keywords: acute cerebral infarction, Vinpocetine
Lead sponsor: Shanghai Rxmidas Pharmaceuticals Co. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Gedeon Richter Ltd.
First posted: 2011-07-22
Enrollment: 610
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Totally 610 subjects were recruited, 469 in test group and 141 in control group.

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mini-Mental State Examination (MMSE)and Modified Rankin Scale
timeFrame: May 2010 - Feb. 2013
Secondary outcomes:
measure: Barthel index and NIHSS
timeFrame: May. 2010 - Feb. 2013
Other outcomes:
Locations:
city: Beijing
country: China
facility: Weiwei Zhang
Study officials:
affiliation: PLA.The Military General Hospital of Beijing
name: Weiwei Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: