Chinese Assessment for Vinpocetine In Neurology

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.

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Key information

Conditions

Cerebral Infarction Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Infarction Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Weiwei Zhang

Beijing, 100700, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Mini-Mental State Examination (MMSE)and Modified Rankin Scale

Time frame: May 2010 - Feb. 2013

Secondary outcomes

Barthel index and NIHSS

Time frame: May. 2010 - Feb. 2013

Sponsors and collaborators

Lead sponsor

Shanghai Rxmidas Pharmaceuticals Co. Ltd.

Industry

Collaborators

Gedeon Richter Ltd.

Registry information

Official study title

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

Acronym: CAVIN

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Jul 22, 2011
Registry last updated: Aug 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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