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

Hypercholesterolemia Clinical Trial

— LAMISIII  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04270344
• Other study ID #: JW-PTVV-01
• Status: Recruiting
• Start date: July 1, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2021
• Source: JW Pharmaceutical
• Contact: Myungho Jeong, Professor
• Phone: 82-62-220-6243
• Email: myungho[@]chol.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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),

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 905
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	JWP	Seoul	Seocho-gu

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