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Completed

NCT Number: NCT00805714

Livalo Acute Myocardial Infarction Study

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.

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Key information

Conditions

Acute Myocardial Infarction

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiac and Vascular Center, Hanseo Hospital, Busan, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patients who have taken pitavastatin since AMI

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. Death/MACE for 1 year after the registration

    Time frame: 1 year

Secondary outcomes

  1. Achievement of LDL cholesterol target level according to the NCEP ATP III guideline

    Time frame: 1 year

  2. Abnormal change of lab value including CK etc

    Time frame: 1 year

  3. Adverse event including myalgia

    Time frame: 1 year

Interested in participating?

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Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study 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

Acronym: LAMIS

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Dec 10, 2008
Registry last updated
Mar 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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