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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04270344

Acronym

LAMISIII

Enrollment

905

Registered

2020-02-17

Start date

2018-07-01

Completion date

2022-06-30

Last updated

2021-04-13

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

Conditions

Hypercholesterolemia

Brief summary

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

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

DRUGPitavastatin 4mg

combination therapy with pitavastatin/valsartan (LivaloV)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Contacts

Primary ContactMyungho Jeong, Professor

myungho@chol.com82-62-220-6243

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026