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Livalo Acute Myocardial Infarction Study (LAMIS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JW Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00805714
First received: December 2, 2008
Last updated: March 28, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition
Acute Myocardial Infarction

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by JW Pharmaceutical:

Primary Outcome Measures:
  • Death/MACE for 1 year after the registration [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Achievement of LDL cholesterol target level according to the NCEP ATP III guideline [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Abnormal change of lab value including CK etc [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Adverse event including myalgia [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 1128
Study Start Date: April 2007
Study Completion Date: March 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Acute myocardial infarction
AMI patients who are in need to be treated by statins

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

AMI patients who are in need to be treated by statins

Criteria

Inclusion Criteria:

  • The patients who have taken pitavastatin since AMI

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00805714

Locations
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
Heart Center, Division of Cardiology, Chung-Ang University Hospital
Seoul, Korea, Republic of
Cardiovascular Center, Korea University Guro Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
JW Pharmaceutical
Investigators
Principal Investigator: Myung Ho Jeong Chonnam National University Hospital
  More Information

No publications provided

Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT00805714     History of Changes
Other Study ID Numbers: PTV-KAMI
Study First Received: December 2, 2008
Last Updated: March 28, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by JW Pharmaceutical:
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
 Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 13, 2013