Livalo Acute Myocardial Infarction Study

Completed

• Conditions: Acute Myocardial Infarction

• Registration Number: NCT00805714
• Lead Sponsor: JW Pharmaceutical

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 available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2008-12-02
• Study First Submitted QC: 2008-12-09
• Study First Posted: 2008-12-10
• Primary Completion: 2010-08
• Study Completion: 2011-03
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-28
• Last Update Posted: 2012-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1128

Inclusion Criteria

• The patients who have taken pitavastatin since AMI

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death/MACE for 1 year after the registration	1 year

Secondary Outcome Measures

Name	Time	Method
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	1 year

Trial Locations

Locations (10)

Department of Cardiovascular Medicine, Wonkwang University School of Medicine; 🇰🇷 Iksan, Korea, Republic of

Cardiac and Vascular Center, Hanseo Hospital; 🇰🇷 Busan, Korea, Republic of

Departments of Cardiology, Catholic University of Daegu College of Medicine; 🇰🇷 Daegu, Korea, Republic of

Division of Cardiology, Department of Internal Medicine, School of Medicine, Keimyung University; 🇰🇷 Daegu, Korea, Republic of

Division of Cardiology, Heart Center, Konyang University; 🇰🇷 Daejeon, Korea, Republic of

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Gachon University Gil Medical Center; 🇰🇷 In Cheon, Korea, Republic of

Division of Cardiology Cardiac Center, Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of

Heart Center, Division of Cardiology, Chung-Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of

Cardiovascular Center, Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of