Livalo Acute Myocardial Infarction Study (LAMIS)

Tracking Information
First Submitted Date	October 18, 2010
First Posted Date	December 23, 2010
Last Update Posted Date	December 15, 2014
Study Start Date	July 2010
Actual Primary Completion Date	May 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: December 12, 2014)	Incidence of TLR-MACE for 1 year after enrollment [ Time Frame: 1 year after enrollment ]
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT01265706 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: December 12, 2014)	Incidence of TVR-MACE for 1 year after enrollment [ Time Frame: 1 year after enrollment ]
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Livalo Acute Myocardial Infarction Study (LAMIS)
Official Title	1-year, Prospective, Randomized, Open-label, Parallel Group Observational Study to Evaluate the Safety and Efficacy of 4mg/Day of Pitavastatin Versus 2mg/Day of Pitavastatin in Acute Myocardial Infarction(AMI)
Brief Summary	This study is performed to observe the incidence of major cardiovascular events in Korean patients with AMI after giving pitavastatin 2mg and 4mg longer than 1 year.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	AMI patients who are in need to be treated by statins
Condition	Acute Myocardial Infarction
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Estimated Enrollment; (submitted: December 22, 2010)	1000
Original Estimated Enrollment	Same as current
Actual Study Completion Date	December 2014
Actual Primary Completion Date	May 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: Patients with STEMI, NSTEMI; Patients satisfying at least one of the followings Patients with LDL-C ≥ 130 mg/dL Patients with LDL-C ≥ 100 mg/dL who are regarded as required cholesterol lowering therapy by the investigator Patients taking statin are required continuous cholesterol lowering therapy; Patients satisfying at least two of the followings The change of Ischemic ECG CK, CK-MB, Troponin-I increased more than two times The symptom of ACS Exclusion Criteria: Patients with in-stent restenosis after PCI or coronary artery bypass; Patients with cardiogenic shock; Patients with severe heart failure (Left ventricular ejection fraction is less than 30%); Patients who are taking cyclosporine; Patients who experienced hypersensitivity to pitavastatin; Patients under dialysis treatment; Patients who are participating other clinical trials; Patients who can not stop taking concomitant drugs; Pregnant or lactating women or suspected pregnancy; Patients who are regarded as ineligible for this study by the investigator
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Senior
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Korea, Republic of
Removed Location Countries
Administrative Information
NCT Number	NCT01265706
Other Study ID Numbers	PTV_LAMIS II
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	JW Pharmaceutical
Study Sponsor	JW Pharmaceutical
Collaborators	Not Provided
Investigators	Principal Investigator: Young Jun Hong Chonnam National University Hospital
PRS Account	JW Pharmaceutical
Verification Date	December 2014