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Livalo Acute Myocardial Infarction Study (LAMIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by JW Pharmaceutical
Sponsor:
Information provided by (Responsible Party):
JW Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01265706
First received: October 18, 2010
Last updated: May 12, 2014
Last verified: May 2014
  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:

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

  • 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 ClinicalTrials.gov identifier: NCT01265706

Locations
Korea, Republic of
Chonnam National University Hospital Recruiting
Gwangju, Korea, Republic of
Contact: Young Jun Hong    82-62-220-5114    hyj200@hanmail.net   
Sponsors and Collaborators
JW Pharmaceutical
Investigators
Principal Investigator: Young Jun Hong Chonnam National University Hospital
  More Information

No publications provided

Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT01265706     History of Changes
Other Study ID Numbers: PTV_LAMIS II_Ver 1.1
Study First Received: October 18, 2010
Last Updated: May 12, 2014
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
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014