Chinese Assessment for Vinpocetine In Neurology (CAVIN)

This study has been completed.
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Weiwei Zhang, Shanghai Rxmidas Pharmaceuticals Co. Ltd.
ClinicalTrials.gov Identifier:
NCT01400035
First received: July 19, 2011
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

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.

Condition
Cerebral Infarction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Investigation of Vinpocetine (Cavinton) for Treatment of Acute Cerebral Infarction, an Open, Multicenter, Randomized, Control Study

Resource links provided by NLM:


Further study details as provided by Shanghai Rxmidas Pharmaceuticals Co. Ltd.:

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 ]

Enrollment: 610
Study Start Date: May 2010
Study Completion Date: May 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.


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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400035

Locations
China
Weiwei Zhang
Beijing, China, 100700
Sponsors and Collaborators
Shanghai Rxmidas Pharmaceuticals Co. Ltd.
Gedeon Richter Ltd.
Investigators
Principal Investigator: Weiwei Zhang, MD PLA.The Military General Hospital of Beijing
  More Information

No publications provided

Responsible Party: Weiwei Zhang, Director of Neurology Department, Shanghai Rxmidas Pharmaceuticals Co. Ltd.
ClinicalTrials.gov Identifier: NCT01400035     History of Changes
Other Study ID Numbers: RMS2010C
Study First Received: July 19, 2011
Last Updated: August 14, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai Rxmidas Pharmaceuticals Co. Ltd.:
acute cerebral infarction, Vinpocetine

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Vinpocetine
Cytidine Diphosphate Choline
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Cardiovascular Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014