The Occurrence of MACE in Patients With AMI Receiving Pit... | NCT04270344

Studies
The Occurrence of MACE in Patients With AMI Receiving Pitavastatin/Valsartan Treatment

NCT04270344

Sponsor

JW Pharmaceutical

Status

Unknown status

Last Update Posted

Apr 13, 2021Actual

Enrollment

905Estimated

Phase

Not provided

Conditions

Hypercholesterolemia

Interventions

Pitavastatin 4mg

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

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2018Actual

Primary Completion Date

Jun 30, 2022Estimated

Completion Date

Jun 30, 2022Estimated

First Submitted Date

Feb 12, 2020

First Submission Date that Met QC Criteria

Feb 12, 2020

First Posted Date

Feb 17, 2020Actual

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

Apr 11, 2021

Last Update Posted Date

Apr 13, 2021Actual

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

Prospective Observation study to identify the rate of MACE in AMI with Livalo V(Pitavastatin/Valsartan) for 12 month in Korea

Detailed Description

Following subjects with AMI event within 1 month will be assessed MACE event for 1year

Essential hypertension or heart failure
Idiopathic hypercholesterolemia (heterogeneous familial and non-familial hypercholesterolemia, Fredrickson classification type IIa)
Mixed-type hypercholesterolemia (Fredrickson classification type IIb) with acute myocardial infarction (STEMI, NSTEMI),

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

905Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pitavastatin 4mg	Drug	combination therapy with pitavastatin/valsartan (LivaloV)		valsartan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
all-cause mortality, non-fatal MI, repeat re-vascularization	MACE	12 months

Secondary Outcomes

Measure	Description	Time Frame
The rate of mortality	MACE	6 and 12 months
The rate of cardiac death	MACE	6 and 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

idiopathic hypercholesterolemia (heterogeneous familial and non-familial, Fredrickson type IIa) or mixed-type (Fredrickson type IIb) with AMI (STEMI, NSTEMI), including essential hypertension or heart failure
diagnosed AMI (STEMI, NSTEMI) 1 months ago
more than 19 years old and more than 2 years of life expectancy at screening
informed consent

Exclusion Criteria:

cardiogenic shock or corresponding clinical events
contraindicated to the IP
unsuitable to this study judged by investigators

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

hypercholesterolemia and AMI

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Myungho Jeong, Professor	Contact	82-62-220-6243		myungho@chol.com

Overall Officials

Name	Affiliation	Role
Myungho Jeong, Professor	Chonnam National University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
JWP	Recruiting	Seoul	Seocho-gu		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
D006937	Hypercholesterolemia

Ancestor Terms

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C108475	pitavastatin
D000068756	Valsartan

Ancestor Terms

ID	Term
D013777	Tetrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided