Chinese Assessment for Vinpocetine In Neurology

NCT01400035 | Completed DMC

• 1 other identifier: RMS2010C
• Study Type: observational
• Target: 610
• Locations: 1 country
• Sites: 1

Brief Summary

Trial Title：The treatment of Vinpocetine（Cavinton）in patients with cerebral infarction, an open, randomized, multi-center control study

1. 1.Objectives Evaluate the efficacy and safety of Vinpocetine（Cavinton）for treatment of cerebral infarction
2. 2.Design Open, randomized, multi-center control study
3. 3.Trial Population:Patients with acute cerebral infarction
4. 4.Number of Subjects 720 patients in test group and 240 patients in control group, totally 960 patients will be recruited.
5. 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.
6. 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. 7.Statistical Analysis: SPSS 11.0 will be used to make the data analysis.

Conditions

Cerebral Infarction

Keywords

acute cerebral infarction, Vinpocetine

Outcome Measures

Primary Outcomes (1)

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

  May 2010 - Feb. 2013

Secondary Outcomes (1)

• Barthel index and NIHSS

  May. 2010 - Feb. 2013

Study Arms (1)

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.

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Rxmidas Pharmaceuticals Co. Ltd.: lead
• Gedeon Richter Ltd.: collaborator

Study Sites (1)

Weiwei Zhang

Beijing, 100700, China

Location

MeSH Terms

Conditions

Cerebral Infarction

Condition Hierarchy (Ancestors)

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

Study Officials

• Weiwei Zhang, MD

  PLA.The Military General Hospital of Beijing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Neurology Department

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: July 22, 2011
• Study Start: May 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 16, 2013

Record last verified: 2013-08

Locations

CN (1)