Chinese Assessment for Vinpocetine In Neurology (CAVIN)

August 14, 2013 updated by: Weiwei Zhang, Shanghai Rxmidas Pharmaceuticals Co. Ltd.

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

610

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100700
        • Weiwei Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Totally 610 subjects were recruited, 469 in test group and 141 in control group.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Barthel index and NIHSS
Time Frame: May. 2010 - Feb. 2013
May. 2010 - Feb. 2013

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Rxmidas Pharmaceuticals Co. Ltd.

Collaborators

Gedeon Richter Ltd.

Investigators

  • Principal Investigator: Weiwei Zhang, MD, PLA.The Military General Hospital of Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

July 19, 2011

First Submitted That Met QC Criteria

July 21, 2011

First Posted (Estimate)

July 22, 2011

Study Record Updates

Last Update Posted (Estimate)

August 16, 2013

Last Update Submitted That Met QC Criteria

August 14, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMS2010C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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