Clinical trial NCT01897883: Dyslipidemia Management in Chinese Post Stroke Patients
Official title: Dyslipidemia Management in Chinese Post Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Ischemia,Stoke
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-07-12
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To observe LDL-C level of China post-stroke patients within 6-12 months from attack
timeFrame: Up to 12 months
measure: To observe control rate of LDL-C of China post-stroke patients within 6-12 months from attack
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Shenzhen
country: China
facility: Research Site
state: Guangdong
city: Haerbin
country: China
facility: Research Site
state: Heilongjiang
city: Zhengzhou
country: China
facility: Research Site
state: Henan
city: Zhenzhou
country: China
facility: Research Site
state: Henan
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Changsha
country: China
facility: Research Site
state: Hunan
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Suzhou
country: China
facility: Research Site
state: Jiangsu
city: Changchun
country: China
facility: Research Site
state: Jilin
city: Shenyang
country: China
facility: Research Site
state: Liaoning
city: Jinan
country: China
facility: Research Site
state: Shandong
city: Qingdao
country: China
facility: Research Site
state: Shandong
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Xi An
country: China
facility: Research Site
state: Shanxi
city: Chengdu
country: China
facility: Research Site
state: Sichuan
city: Chongqing
country: China
facility: Research Site
state: Sichuan
city: Tianjin
country: China
facility: Research Site
state: Tianjin
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
city: Ruian
country: China
facility: Research Site
state: Zhejiang
city: Taizhou
country: China
facility: Research Site
state: Zhejiang
city: Wenzhou
country: China
facility: Research Site
state: Zhejiang
city: Beijing
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
Study officials:
affiliation: Capital Medical University afffiliated Beijing Tiantan Hospital
name: Yong Jun Wang
role: PRINCIPAL_INVESTIGATOR
References: