Livalo Acute Myocardial Infarction Study (LAMIS)

Acute Myocardial Infarction Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01265706
• Other study ID #: PTV_LAMIS II
• Status: Completed
• Phase: N/A
• First received: October 18, 2010
• Last updated: December 12, 2014
• Start date: July 2010
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: JW Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hospital	Gwangju

Sponsors (1)

Lead Sponsor	Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of TLR-MACE for 1 year after enrollment		1 year after enrollment	Yes
Secondary	Incidence of TVR-MACE for 1 year after enrollment		1 year after enrollment	Yes