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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 30, 2022

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),

Interventions

  • Drug: Pitavastatin 4mg
    • combination therapy with pitavastatin/valsartan (LivaloV)

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • JW Pharmaceutical
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Myungho Jeong, Professor, Study Chair, Chonnam National University Hospital
  • Overall Contact(s)
    • Myungho Jeong, Professor, 82-62-220-6243, myungho@chol.com

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