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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:
NCT01265706
First received: October 18, 2010
Last updated: December 12, 2014
Last verified: December 2014
History of Changes

October 18, 2010
December 12, 2014
July 2010
May 2014   (final data collection date for primary outcome measure)
Incidence of TLR-MACE for 1 year after enrollment [ Time Frame: 1 year after enrollment ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT01265706 on ClinicalTrials.gov Archive Site
Incidence of TVR-MACE for 1 year after enrollment [ Time Frame: 1 year after enrollment ] [ Designated as safety issue: Yes ]
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Livalo Acute Myocardial Infarction Study (LAMIS)
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)
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.
Not Provided
Observational
Time Perspective: Prospective
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Probability Sample
AMI patients who are in need to be treated by statins
Acute Myocardial Infarction
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
December 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with STEMI, NSTEMI

  • Patients satisfying at least one of the followings

    1. Patients with LDL-C ≥ 130 mg/dL
    2. Patients with LDL-C ≥ 100 mg/dL who are regarded as required cholesterol lowering therapy by the investigator
    3. Patients taking statin are required continuous cholesterol lowering therapy

  • Patients satisfying at least two of the followings

    1. The change of Ischemic ECG
    2. CK, CK-MB, Troponin-I increased more than two times
    3. The symptom of ACS

Exclusion Criteria:

  1. Patients with in-stent restenosis after PCI or coronary artery bypass
  2. Patients with cardiogenic shock
  3. Patients with severe heart failure (Left ventricular ejection fraction is less than 30%)
  4. Patients who are taking cyclosporine
  5. Patients who experienced hypersensitivity to pitavastatin
  6. Patients under dialysis treatment
  7. Patients who are participating other clinical trials
  8. Patients who can not stop taking concomitant drugs
  9. Pregnant or lactating women or suspected pregnancy
  10. Patients who are regarded as ineligible for this study by the investigator
Both
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01265706
PTV_LAMIS II
No
Not Provided
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JW Pharmaceutical
JW Pharmaceutical
Not Provided
Principal Investigator: Young Jun Hong Chonnam National University Hospital
JW Pharmaceutical
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP