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Dyslipidemia Management in Chinese Post Stroke Patients

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ClinicalTrials.gov Identifier: NCT01897883
Recruitment Status : Completed
First Posted : July 12, 2013
Last Update Posted : July 30, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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.


Condition or disease
Brain Ischemia,Stoke

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 Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Dyslipidemia Management in Chinese Post Stroke Patients
Study Start Date : July 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Group/Cohort
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.



Primary Outcome Measures :
  1. 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.

  2. To observe control rate of LDL-C of China post-stroke patients within 6-12 months from attack [ Time Frame: Up to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01897883


  Show 26 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Yong Jun Wang Capital Medical University afffiliated Beijing Tiantan Hospital

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01897883     History of Changes
Other Study ID Numbers: NIS-NCN-XXX-2013/1
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: July 30, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Ischemia
Dyslipidemias
Brain Ischemia
Pathologic Processes
Lipid Metabolism Disorders
Metabolic Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases