Dyslipidemia Management in Chinese Post Stroke Patients | NCT01897883

Studies
Dyslipidemia Management in Chinese Post Stroke Patients

NCT01897883

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jul 30, 2015Estimated

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Brain Ischemia,Stoke

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Aug 2014Actual

Completion Date

Aug 2014Actual

First Submitted Date

Jul 3, 2013

First Submission Date that Met QC Criteria

Jul 10, 2013

First Posted Date

Jul 12, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2015

Last Update Posted Date

Jul 30, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
To observe control rate of LDL-C of China post-stroke patients within 6-12 months from attack		Up to 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yong Jun Wang	Capital Medical University afffiliated Beijing Tiantan Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Beijing	Beijing Municipality		China
Research Site

Label	URL
CSR Synopsis	View source

Condition Browse Module

MeSH Terms

ID	Term
D002545	Brain Ischemia

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

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Browse Branches

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