Livalo Acute Myocardial Infarction Study

Acute Myocardial Infarction Clinical Trial

— LAMIS  

Official title:

A Prospective Clinical Observation Study to Evaluate the Influence of Long Term Treatment of Pitavastatin on the Therapeutic Prognosis and Safety in Acute Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00805714
• Other study ID #: PTV-KAMI
• Status: Completed
• Phase: N/A
• First received: December 2, 2008
• Last updated: March 28, 2012
• Start date: April 2007
• Est. completion date: March 2011

Study information

• Verified date: March 2012
• Source: JW Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1128
• Est. completion date: March 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• The patients who have taken pitavastatin since AMI

Exclusion Criteria:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
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	Department of Cardiovascular Medicine, Wonkwang University School of Medicine	Iksan
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	Cardiovascular Center, Korea University Guro Hospital	Seoul
Korea, Republic of	Heart Center, Division of Cardiology, Chung-Ang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death/MACE for 1 year after the registration		1 year	No
Secondary	Achievement of LDL cholesterol target level according to the NCEP ATP III guideline		1 year	Yes
Secondary	Abnormal change of lab value including CK etc		1 year	Yes
Secondary	Adverse event including myalgia		1 year	Yes