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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01897883
Other study ID # NIS-NCN-XXX-2013/1
Secondary ID
Status Completed
Phase N/A
First received July 3, 2013
Last updated July 29, 2015
Start date July 2013
Est. completion date August 2014

Study information

Verified date July 2015
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Observational

Clinical 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.

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 5000
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Male or female with age = 18 years

2. Post ischemic stroke patients within 6-12 months from attack

3. written informed consent is provided to participant in the study

Exclusion Criteria:

1. Significant medical or psychological condition that make patients can not finish the questionnaire independently or with the aids of his/her legal representatives

2. The patient is or will be in another clinical study

3. Previous enrolment in the present study

Study Design

Observational Model: Case-Crossover, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
China Research Site Beijing Beijing
China Research Site Beijing
China Research Site Changchun Jilin
China Research Site Changsha Hunan
China Research Site Chengdu Sichuan
China Research Site Chongqing Sichuan
China Research Site Guangzhou
China Research Site Guangzhou Guangdong
China Research Site Haerbin Heilongjiang
China Research Site Hangzhou Zhejiang
China Research Site Jinan Shandong
China Research Site Nanjing Jiangsu
China Research Site Qingdao Shandong
China Research Site Ruian Zhejiang
China Research Site Shanghai Shanghai
China Research Site Shanghai
China Research Site Shenyang Liaoning
China Research Site Shenzhen Guangdong
China Research Site Suzhou Jiangsu
China Research Site Taizhou Zhejiang
China Research Site Tianjin Tianjin
China Research Site Wenzhou Zhejiang
China Research Site Wuhan Hubei
China Research Site Xi An Shanxi
China Research Site Zhengzhou Henan
China Research Site Zhenzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 12 months No
Primary To observe control rate of LDL-C of China post-stroke patients within 6-12 months from attack Up to 12 months No

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