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

• Conditions: Hypercholesterolemia

• Registration Number: NCT04270344
• Lead Sponsor: JW Pharmaceutical

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),

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-02-12
• Study First Posted: 2020-02-17
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-11
• Last Update Posted: 2021-04-13
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 905

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
all-cause mortality, non-fatal MI, repeat re-vascularization	12 months	MACE

Secondary Outcome Measures

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

Trial Locations

Locations (1)

JWP; 🇰🇷 Seoul, Seocho-gu, Korea, Republic of