Clinical trial NCT00805714: Livalo Acute Myocardial Infarction Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: Hydroxymethylglutaryl-CoA Reductase Inhibitors
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-12-10
Enrollment: 1128
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: AMI patients who are in need to be treated by statins

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.


Eligibility criteria: Inclusion Criteria:

* The patients who have taken pitavastatin since AMI

Exclusion Criteria:

* none

Primary outcomes:
measure: Death/MACE for 1 year after the registration
timeFrame: 1 year
Secondary outcomes:
measure: Achievement of LDL cholesterol target level according to the NCEP ATP III guideline
timeFrame: 1 year
measure: Abnormal change of lab value including CK etc
timeFrame: 1 year
measure: Adverse event including myalgia
timeFrame: 1 year
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Cardiac and Vascular Center, Hanseo Hospital
city: Daegu
country: Korea, Republic of
facility: Departments of Cardiology, Catholic University of Daegu College of Medicine
city: Daegu
country: Korea, Republic of
facility: Division of Cardiology, Department of Internal Medicine, School of Medicine, Keimyung University
city: Daejeon
country: Korea, Republic of
facility: Division of Cardiology, Heart Center, Konyang University
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Iksan
country: Korea, Republic of
facility: Department of Cardiovascular Medicine, Wonkwang University School of Medicine
city: In Cheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seongnam
country: Korea, Republic of
facility: Division of Cardiology Cardiac Center, Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Cardiovascular Center, Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Heart Center, Division of Cardiology, Chung-Ang University Hospital
Study officials:
affiliation: Chonnam National University Hospital
name: Myung Ho Jeong
role: PRINCIPAL_INVESTIGATOR
References: