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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01265706

Enrollment

1000

Registered

2010-12-23

Start date

2010-07-31

Completion date

2014-12-31

Last updated

2014-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Keywords

Hydroxymethylglutaryl-CoA Reductase Inhibitors

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of TLR-MACE for 1 year after enrollment	1 year after enrollment

Secondary

Measure	Time frame
Incidence of TVR-MACE for 1 year after enrollment	1 year after enrollment

Countries

South Korea

Outcome results