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Chinese Assessment for Vinpocetine In Neurology

NCT ID: NCT01400035

Last Updated: 2013-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

610 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-05-31

Brief Summary

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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

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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.

Conditions

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Cerebral Infarction

Keywords

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acute cerebral infarction, Vinpocetine

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gedeon Richter Ltd.

INDUSTRY

Sponsor Role collaborator

Shanghai Rxmidas Pharmaceuticals Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Weiwei Zhang

Director of Neurology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weiwei Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

PLA.The Military General Hospital of Beijing

Locations

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Weiwei Zhang

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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RMS2010C

Identifier Type: -

Identifier Source: org_study_id