Brain Ischemia,StokeNCT01897883
Dyslipidemia Management in Chinese Post Stroke Patients
An observational study of Brain Ischemia,Stoke, run by AstraZeneca at 26 sites in China.
Trial summary
The purpose of this study is to provide current and reliable data of dyslipidimia management together with control situation of blood pressure and glucose for post-stroke patients within 6-12 months from attack, and also the association between patient characteristics and control rate of lipids in this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Ischemia,Stoke
- How many people
- 5,000 participants
- Where
- 26 sitesChina
- Study dates
- Jul 2013to Aug 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Post -ischemic stroke patients within 6-12 months from attack, with age ≥ 18 years old. Subject ( or his legal representative) must demonstrate his or her willingness to participate in the survey and comply with its procedures by signing a written consent. Subjects who are unwilling or unable to provide informed consent will be excluded
Who may be able to join
- Male or female with age ≥ 18 years
- Post ischemic stroke patients within 6-12 months from attack
- written informed consent is provided to participant in the study
Who cannot join
- Significant medical or psychological condition that make patients can not finish the questionnaire independently or with the aids of his/her legal representatives
- The patient is or will be in another clinical study
- Previous enrolment in the present study
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
China26 sites
Research Site
Beijing, Beijing Municipality
Research Site
Beijing
Research Site
Changchun, Jilin
Research Site
Changsha, Hunan
Research Site
Chengdu, Sichuan
Research Site
Chongqing, Sichuan
Research Site
Guangzhou, Guangdong
Research Site
Guangzhou
Research Site
Haerbin, Heilongjiang
Research Site
Hangzhou, Zhejiang
Research Site
Jinan, Shandong
Research Site
Nanjing, Jiangsu
Research Site
Qingdao, Shandong
Research Site
Ruian, Zhejiang
Research Site
Shanghai, Shanghai Municipality
Research Site
Shanghai
Research Site
Shenyang, Liaoning
Research Site
Shenzhen, Guangdong
Research Site
Suzhou, Jiangsu
Research Site
Taizhou, Zhejiang
Research Site
Tianjin, Tianjin Municipality
Research Site
Wenzhou, Zhejiang
Research Site
Wuhan, Hubei
Research Site
Xi’an, Shanxi
Research Site
Zhengzhou, Henan
Research Site
Zhenzhou, Henan
About this study
The purpose of this study is to provide current and reliable data of dyslipidimia management together with control situation of blood pressure and glucose for post-stroke patients within 6-12 months from attack, and also the association between patient characteristics and control rate of lipids in this population.
It is an non-interventional study, no study specified treatment is required.Approximately 5000 post ischemic stroke patients within 6-12 months from attack will enter into the study. Fifty centres from different regions of China will participate in this study.
Read the detailed description
This is a multicentre, cross-sectional, observational study, aiming to investigate the prevalence and control situation of dyslipidimia in China post ischemic stroke patients within 6-12 months from attack. Patients will be screened consecutively, eligible subjects will be interviewed by investigator and finish a questionire during the visit. Investigator will collect relevant medical history, physical exam results and lab test results including blood lipid (i.e. Triglyceride, Total Cholesterol, LDL-C, HDL-C) and glucose(HbA1c if available).Approximately 5000 post ischemic stroke patients within 6-12 months from attack will enter into the study. Fifty centres from different regions of China will participate in this study.
- Conditions
- Brain Ischemia,Stoke
- Medical subject headings
- Brain Ischemia
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 |
|---|---|---|
| One Group | Full Analysis Set (FAS) will be the primary analysis set. All post ischemic stroke patients within 6-12 months from attack (i.e., with inclusion criterion No.2 fulfilled) except the screening failure patients, i.e., those who withdraw from the study once the informed consent is given, will be included in the FAS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To observe LDL-C level of China post-stroke patients within 6-12 months from attack
Investigator will collect lab test results including blood lipid (i.e. Triglyceride, Total Cholesterol, LDL-C, HDL-C) during the patient visit.
Measured: Up to 12 months
To observe control rate of LDL-C of China post-stroke patients within 6-12 months from attack
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Ischemia,StokeStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yong Jun Wang, Principal investigator, Capital Medical University afffiliated Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897883
- Sponsor's protocol ID
- NIS-NCN-XXX-2013/1
- Status last verified
- Jul 2015
- First submitted
- 3 Jul 2013
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyslipidemia Management in Chinese Post Stroke Patients
- ClinicalTrials.gov ID
- NCT01897883
- Acronym / sponsor ID
- NIS-NCN-XXX-2013/1
- Conditions
- Brain Ischemia,Stoke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 12 Jul 2013 (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.
The purpose of this study is to provide current and reliable data of dyslipidimia management together with control situation of blood pressure and glucose for post-stroke patients within 6-12 months from attack, and also the association between patient characteristics and control rate of lipids in this population.
It is an non-interventional study, no study specified treatment is required.Approximately 5000 post ischemic stroke patients within 6-12 months from attack will enter into the study. Fifty centres from different regions of China will participate in this study.
Detailed description
This is a multicentre, cross-sectional, observational study, aiming to investigate the prevalence and control situation of dyslipidimia in China post ischemic stroke patients within 6-12 months from attack. Patients will be screened consecutively, eligible subjects will be interviewed by investigator and finish a questionire during the visit. Investigator will collect relevant medical history, physical exam results and lab test results including blood lipid (i.e. Triglyceride, Total Cholesterol, LDL-C, HDL-C) and glucose(HbA1c if available).Approximately 5000 post ischemic stroke patients within 6-12 months from attack will enter into the study. Fifty centres from different regions of China will participate in this study.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One Group | – | –Full Analysis Set (FAS) will be the primary analysis set. All post ischemic stroke patients within 6-12 months from attack (i.e., with inclusion criterion No.2 fulfilled) except the screening failure patients, i.e., those who withdraw from the study once the informed consent is given, will be included in the FAS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post -ischemic stroke patients within 6-12 months from attack, with age ≥ 18 years old. Subject ( or his legal representative) must demonstrate his or her willingness to participate in the survey and comply with its procedures by signing a written consent. Subjects who are unwilling or unable to provide informed consent will be excluded
Key inclusion criteria (3 listed)
- Male or female with age ≥ 18 years
- Post ischemic stroke patients within 6-12 months from attack
- written informed consent is provided to participant in the study
Key exclusion criteria (3 listed)
- Significant medical or psychological condition that make patients can not finish the questionnaire independently or with the aids of his/her legal representatives
- The patient is or will be in another clinical study
- Previous enrolment in the present study
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
To observe LDL-C level of China post-stroke patients within 6-12 months from attack
Time frame: Up to 12 months
Investigator will collect lab test results including blood lipid (i.e. Triglyceride, Total Cholesterol, LDL-C, HDL-C) during the patient visit.
To observe control rate of LDL-C of China post-stroke patients within 6-12 months from attack
Time frame: Up to 12 months
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 30 Jul 2015.
- CSR SynopsisLink provided by the sponsor.
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.
Yong Jun Wang principal investigator
Capital Medical University afffiliated Beijing Tiantan Hospital
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Ischemia,Stoke, run by AstraZeneca at 26 sites 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 3 inclusion and 3 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 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites 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?
To observe LDL-C level of China post-stroke patients within 6-12 months from attack (time frame: Up to 12 months). The study lists 2 primary outcomes in all. 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 30 Jul 2015.