Livalo Acute Myocardial Infarction Study | NCT00805714

Studies
Livalo Acute Myocardial Infarction Study

NCT00805714

Sponsor

JW Pharmaceutical

Status

Completed

Last Update Posted

Mar 30, 2012Estimated

Enrollment

1,128Actual

Phase

Not provided

Conditions

Acute Myocardial Infarction

Interventions

Not provided

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

Mar 2012

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

Apr 2007

Primary Completion Date

Aug 2010Actual

Completion Date

Mar 2011Actual

First Submitted Date

Dec 2, 2008

First Submission Date that Met QC Criteria

Dec 9, 2008

First Posted Date

Dec 10, 2008Estimated

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

Mar 28, 2012

Last Update Posted Date

Mar 30, 2012Estimated

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

Statins are usually used in AMI patients due to its strong anti-lipidemic effect, pleiotropic effect and tolerable safety profiles. Generally AMI patients are prescribed many drugs concomitantly; there are some risks due to the drug interaction. Especially, statins are reported to have many drug interactions, these might influence to therapeutic prognosis and safety in AMI patients.

This study is conducted to administer the non-CYP3A4 metabolized statin, pitavastatin to AMI patients over 1 year, and the results will be compared with the other results from the KAMIR study which is expected to the large scale of AMI patients using statins be enrolled. Finally, from that comparison, we will investigate the influence of the statins metabolism by CYP3A4 to the therapeutic prognosis like death, major adverse cardiac events(MACE), and major ADR of statins like CK increase, myalgia.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,128Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acute myocardial infarction		AMI patients who are in need to be treated by statins

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Death/MACE for 1 year after the registration		1 year

Secondary Outcomes

Measure	Description	Time Frame
Achievement of LDL cholesterol target level according to the NCEP ATP III guideline		1 year
Abnormal change of lab value including CK etc		1 year
Adverse event including myalgia

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patients who have taken pitavastatin since AMI

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

AMI patients who are in need to be treated by statins

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Myung Ho Jeong	Chonnam National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiac and Vascular Center, Hanseo Hospital		Busan			South Korea
Departments of Cardiology, Catholic University of Daegu College of Medicine