Observational Study to Assess the Incidence Rate of the Major Adverse Cardiovascular Events (MACE) and Safety of Fenofibrate (Lipilfen Capsule)

Multi-center, Prospective, Observational Study to Assess the Incidence Rate of the Major Adverse Cardiovascular Events (MACE) and Safety of Fenofibrate (Lipilfen Capsule) Add-on to Statin Therapy in Patients Who Have History of Acute Myocardial Infarction and Are Diagnosed With Metabolic Syndrome

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02069717

Enrollment

Registered

2014-02-24

Start date

2013-10-31

Completion date

2014-09-30

Last updated

2016-10-26

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

Conditions

Metabolic Syndrome

Brief summary

The purpose of this study was to assess the incidence rate of the major adverse cardiovascular events (MACE) and safety of fenofibrate (Lipilfen capsule) add-on statin therapy in patients who have history of acute myocardial infarction and are diagnosed with metabolic syndrome.

Interventions

OTHERNot applicable-observational study

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* patients \>20 years of age. * history of acute myocardial infarction * metabolic syndrome diagnosis

Exclusion criteria

* current liver disease or AST or ALT greater than 3 times the upper limit of reference range * pre-existing gallbladder disease * moderate to severe renal disorder (serum creatinine \>2.5mg/dL) * pancreatitis diagnosis

Design outcomes

Primary

Measure	Time frame	Description
The incidence rate of the major adverse cardiovascular events (MACE)	24 months	cardiac death, MI, re-PCI, CABG

Secondary

Measure	Time frame	Description
The incidence rate of the major adverse cardiac and cerebrovascular event (MACCE)	24 months	non-cardiac death, stroke, hospitalization for acute coronary syndrome

Countries

South Korea

Outcome results

None listed

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