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Livalo Acute Myocardial Infarction Study (LAMIS)

This study has been completed.
Information provided by (Responsible Party):
JW Pharmaceutical Identifier:
First received: October 18, 2010
Last updated: December 12, 2014
Last verified: December 2014
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.

Acute Myocardial Infarction

Study Type: Observational
Study Design: Time Perspective: Prospective
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)

Resource links provided by NLM:

Further study details as provided by JW Pharmaceutical:

Primary Outcome Measures:
  • Incidence of TLR-MACE for 1 year after enrollment [ Time Frame: 1 year after enrollment ]

Secondary Outcome Measures:
  • Incidence of TVR-MACE for 1 year after enrollment [ Time Frame: 1 year after enrollment ]

Estimated Enrollment: 1000
Study Start Date: July 2010
Study Completion Date: December 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
AMI patients who are in need to be treated by statins

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01265706

Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of
Sponsors and Collaborators
JW Pharmaceutical
Principal Investigator: Young Jun Hong Chonnam National University Hospital
  More Information

Responsible Party: JW Pharmaceutical Identifier: NCT01265706     History of Changes
Other Study ID Numbers: PTV_LAMIS II
Study First Received: October 18, 2010
Last Updated: December 12, 2014

Keywords provided by JW Pharmaceutical:
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents processed this record on September 20, 2017