Effects of Pitavastatin Treatments on the Plasma Lgi3 Lev... | NCT03730038

Studies
Effects of Pitavastatin Treatments on the Plasma Lgi3 Level in the Patients With Dyslipidemia

NCT03730038

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Oct 19, 2020Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Dyslipidemias

Interventions

Treatment of pitavastatin 4 mg qd for 12 weeks
Life-style modification

Countries

South Korea

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

Oct 2020

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

Feb 18, 2019Actual

Primary Completion Date

Feb 13, 2020Actual

Completion Date

Feb 13, 2020Actual

First Submitted Date

Nov 1, 2018

First Submission Date that Met QC Criteria

Nov 1, 2018

First Posted Date

Nov 5, 2018Actual

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

Oct 14, 2020

Last Update Posted Date

Oct 19, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Leucine-rich glioma inactivated 3(Lgi3) has been postulated to have a pro-inflammatory adipokine that inter-plays with other adipokines in adipogenesis and metabolic inflammation according to recent investigations. Thus, in this study, we sought to demonstrate that the treatment of statin can decrease Lgi3 level along with the decrease of the atherosclerosis to further evaluate the role of Lgi3 in atherosclerosis.

Detailed Description

Patients who assigned to the pitavastatin treatment first group will be given the pitavastatin 4 mg qd treatment for 12 weeks after randomization, followed by wash-out period of 3 weeks and life-style modification treatment for 12 weeks. Similarly, patients who assigned to the life-style modification treatment first group, will be treated with life-style modification treatment for 12 weeks after randomization, followed by wash-out period of 3 weeks and pitavastatin treatment for 12 weeks.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pitavastatin treatment	Experimental	Treatment of pitavastatin 4 mg qd for 12 weeks	Drug: Treatment of pitavastatin 4 mg qd for 12 weeks
Life-style modification	Active Comparator		Behavioral: Life-style modification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Treatment of pitavastatin 4 mg qd for 12 weeks	Drug	Treatment of pitavastatin 4 mg qd for 12 weeks	Pitavastatin treatment

Measure	Description	Time Frame
Changes in Lgi3 level		At 12 weeks after intervention

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 20-80 years
Patients with intermediate or low cardiovascular risks needing the statin treatment
Patients with intermediate or low cardiovascular risks treating the statin treatment

Exclusion Criteria:

Patients without signed informed consent
Patients with myopathy
Pregnant women or women with potential childbearing
Patients with diabetes
Patients with established coronary artery disease
Patients with heart failure
Life expectancy less than 1 year

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine		Seoul		03722	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050171	Dyslipidemias

Ancestor Terms

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

Patients who assigned to the pitavastatin treatment first group will be given the pitavastatin, followed by wash-out period and life-style modification treatment. Patients who assigned to the life-style modification treatment first group, will be treated with life-style modification treatment first, followed by wash-out period and pitavastatin treatment.