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

JW Pharmaceutical905 enrolled

Overview

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

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

905

Conditions

Hypercholesterolemia

Interventions

Pitavastatin 4mgDRUG

combination therapy with pitavastatin/valsartan (LivaloV)

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

JWP

Seoul, Seocho-gu, South Korea

RECRUITING

Outcomes

Primary Outcomes

all-cause mortality, non-fatal MI, repeat re-vascularization

MACE

Time frame: 12 months

Secondary Outcomes

The rate of mortality

MACE

Time frame: 6 and 12 months

The rate of cardiac death

MACE

Time frame: 6 and 12 months

The rate of nonfatal MI

MACE

Time frame: 6 and 12 months

The rate of hospitalization due to heart failure

MACE

Time frame: 6 and 12 months

The rate of Coronary artery bypass graft(CABG)

MACE

Time frame: 6 and 12 months

The rate of target lesion re-vascularization

MACE

Time frame: 6 and 12 months

The rate of target vessel re-vascularization

MACE

Time frame: 6 and 12 months

The rate of cerebrovascular disease

MACE

Time frame: 6 and 12 months

The change of SBP, DBP

Hypertensive parameters

Central Contacts

Myungho Jeong, Professor

CONTACT

82-62-220-6243 myungho@chol.com

Data from ClinicalTrials.gov

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