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Livalo Acute Myocardial Infarction Study (LAMIS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01265706
First Posted: December 23, 2010
Last Update Posted: December 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
JW Pharmaceutical
  Purpose
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.

Condition
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)
  Eligibility

Information from the National Library of Medicine

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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
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265706


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

Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT01265706     History of Changes
Other Study ID Numbers: PTV_LAMIS II
First Submitted: October 18, 2010
First Posted: December 23, 2010
Last Update Posted: December 15, 2014
Last Verified: December 2014

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
Enzyme Inhibitors
Lipid Regulating Agents