Cerebral InfarctionCAVINNCT01400035
Chinese Assessment for Vinpocetine In Neurology
An observational study of Cerebral Infarction, run by Shanghai Rxmidas Pharmaceuticals Co. Ltd. at 1 site in China.
Trial 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（Cavinton）for treatment of cerebral infarction 2. Design Open, randomized, multi-center control study 3. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cerebral Infarction
- Type of treatment
- Injection or infusion
- How many people
- 610 participants
- Where
- 1 siteChina
- Study dates
- May 2010to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Totally 610 subjects were recruited, 469 in test group and 141 in control group.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Investigation of Vinpocetine (Cavinton) for Treatment of Acute Cerebral Infarction, an Open, Multicenter, Randomized, Control Study
Trial Title：The treatment of Vinpocetine（Cavinton）in patients with cerebral infarction, an open, randomized, multi-center control study
- Objectives Evaluate the efficacy and safety of Vinpocetine（Cavinton）for treatment of cerebral infarction
- Design Open, randomized, multi-center control study
- Trial Population:Patients with acute cerebral infarction
- Number of Subjects 720 patients in test group and 240 patients in control group, totally 960 patients will be recruited.
- 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.
- 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
- Statistical Analysis: SPSS 11.0 will be used to make the data analysis.
Read the 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.
- Conditions
- Cerebral Infarction
- Keywords
- acute cerebral infarction, Vinpocetine
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination (MMSE)and Modified Rankin Scale
Measured: May 2010 - Feb. 2013
Secondary outcomes (1)
Barthel index and NIHSS
Measured: May. 2010 - Feb. 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startMay 2010
- Primary completionFeb 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 610 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Rxmidas Pharmaceuticals Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gedeon Richter Ltd.
- Responsible party
- Principal investigator, Weiwei Zhang, Shanghai Rxmidas Pharmaceuticals Co. Ltd.
- Investigators
- Weiwei Zhang, MD, Principal investigator, PLA.The Military General Hospital of Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400035
- Sponsor's protocol ID
- RMS2010C
- Acronym
- CAVIN
- Status last verified
- Aug 2013
- First submitted
- 19 Jul 2011
- Last updated
- 16 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of Vinpocetine (Cavinton) for Treatment of Acute Cerebral Infarction, an Open, Multicenter, Randomized, Control Study
- ClinicalTrials.gov ID
- NCT01400035
- Acronym / sponsor ID
- CAVIN / RMS2010C
- Conditions
- Cerebral Infarction
- Keywords
- acute cerebral infarction, Vinpocetine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 610 participants (actual)
- Lead sponsor
- Shanghai Rxmidas Pharmaceuticals Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Gedeon Richter Ltd.
- Study start
- May 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 22 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Trial Title：The treatment of Vinpocetine（Cavinton）in patients with cerebral infarction, an open, randomized, multi-center control study
- Objectives Evaluate the efficacy and safety of Vinpocetine（Cavinton）for treatment of cerebral infarction
- Design Open, randomized, multi-center control study
- Trial Population:Patients with acute cerebral infarction
- Number of Subjects 720 patients in test group and 240 patients in control group, totally 960 patients will be recruited.
- 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.
- 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
- Statistical Analysis: SPSS 11.0 will be used to make the data analysis.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Totally 610 subjects were recruited, 469 in test group and 141 in control group.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mini-Mental State Examination (MMSE)and Modified Rankin Scale
Time frame: May 2010 - Feb. 2013
1 secondary outcome
Barthel index and NIHSS
Time frame: May. 2010 - Feb. 2013
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weiwei Zhang, MD principal investigator
PLA.The Military General Hospital of Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Infarction, run by Shanghai Rxmidas Pharmaceuticals Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination (MMSE)and Modified Rankin Scale (time frame: May 2010 - Feb. 2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2013.