Status:
COMPLETED
Chinese Assessment for Vinpocetine In Neurology
Lead Sponsor:
Shanghai Rxmidas Pharmaceuticals Co. Ltd.
Collaborating Sponsors:
Gedeon Richter Ltd.
Conditions:
Cerebral Infarction
Eligibility:
All Genders
40-80 years
Brief 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（C...
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 Mod...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
610 Patients enrolled
Trial Details
Trial ID
NCT01400035
Start Date
May 1 2010
End Date
May 1 2013
Last Update
August 16 2013
Active Locations (1)
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1
Weiwei Zhang
Beijing, China, 100700