Chinese Assessment for Vinpocetine In Neurology

Cerebral Infarction Clinical Trial

— CAVIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01400035
• Other study ID #: RMS2010C
• Status: Completed
• Phase: N/A
• First received: July 19, 2011
• Last updated: August 14, 2013
• Start date: May 2010
• Est. completion date: May 2013

Study information

• Verified date: August 2013
• Source: Shanghai Rxmidas Pharmaceuticals Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 610
• Est. completion date: May 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction

Locations

Country	Name	City	State
China	Weiwei Zhang	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Rxmidas Pharmaceuticals Co. Ltd.	Gedeon Richter Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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