The Occurrence of MACE in Patients With AMI Receiving Pitavastatin/Valsartan Treatment (LAMISIII)

April 11, 2021 updated by: JW Pharmaceutical

A 12-month Open-label, Multicenter Observation Study on the Occurrence of Major Adverse Cardiac Events (MACE) in Patients With Acute Myocardial Infarction (AMI) Receiving Pitavastatin/Valsartan Treatment

Prospective Observation study to identify the rate of MACE in AMI with Livalo V(Pitavastatin/Valsartan) for 12 month in Korea

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Following subjects with AMI event within 1 month will be assessed MACE event for 1year

  • Essential hypertension or heart failure
  • Idiopathic hypercholesterolemia (heterogeneous familial and non-familial hypercholesterolemia, Fredrickson classification type IIa)
  • Mixed-type hypercholesterolemia (Fredrickson classification type IIb) with acute myocardial infarction (STEMI, NSTEMI),

Study Type

Observational

Enrollment (Anticipated)

905

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Myungho Jeong, Professor
  • Phone Number: 82-62-220-6243
  • Email: myungho@chol.com

Study Locations

  • Korea, Republic of
    • Seocho-gu
      • Seoul, Seocho-gu, Korea, Republic of
        • Recruiting
        • JWP
        • Contact:
        • Principal Investigator:
          • Jeong Myung Ho, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

hypercholesterolemia and AMI

Description

Inclusion Criteria:

  • idiopathic hypercholesterolemia (heterogeneous familial and non-familial, Fredrickson type IIa) or mixed-type (Fredrickson type IIb) with AMI (STEMI, NSTEMI), including essential hypertension or heart failure
  • diagnosed AMI (STEMI, NSTEMI) 1 months ago
  • more than 19 years old and more than 2 years of life expectancy at screening
  • informed consent

Exclusion Criteria:

  • cardiogenic shock or corresponding clinical events
  • contraindicated to the IP
  • unsuitable to this study judged by investigators

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all-cause mortality, non-fatal MI, repeat re-vascularization
Time Frame: 12 months
MACE
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of mortality
Time Frame: 6 and 12 months
MACE
6 and 12 months
The rate of cardiac death
Time Frame: 6 and 12 months
MACE
6 and 12 months
The rate of nonfatal MI
Time Frame: 6 and 12 months
MACE
6 and 12 months
The rate of hospitalization due to heart failure
Time Frame: 6 and 12 months
MACE
6 and 12 months
The rate of Coronary artery bypass graft(CABG)
Time Frame: 6 and 12 months
MACE
6 and 12 months
The rate of target lesion re-vascularization
Time Frame: 6 and 12 months
MACE
6 and 12 months
The rate of target vessel re-vascularization
Time Frame: 6 and 12 months
MACE
6 and 12 months
The rate of cerebrovascular disease
Time Frame: 6 and 12 months
MACE
6 and 12 months
The change of SBP, DBP
Time Frame: 6 and 12 months
Hypertensive parameters
6 and 12 months
The change of TC, TG, HDL-C, LDL-C, hsCRP
Time Frame: 6 and 12 months
Lipid parameters
6 and 12 months
The change of HbA1c, FBS
Time Frame: 6 and 12 months
No Onset of Diabetes
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JW Pharmaceutical

Investigators

  • Study Chair: Myungho Jeong, Professor, Chonnam National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

February 12, 2020

First Submitted That Met QC Criteria

February 12, 2020

First Posted (Actual)

February 17, 2020

Study Record Updates

Last Update Posted (Actual)

April 13, 2021

Last Update Submitted That Met QC Criteria

April 11, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JW-PTVV-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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