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

N/AWithdrawnNCT02069717

Daewoong Pharmaceutical Co. LTD.

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Metabolic Syndrome

Interventions

Not applicable-observational studyOTHER

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Chonnam national university hospital

Gwangju, South Korea

Outcomes

Primary Outcomes

The incidence rate of the major adverse cardiovascular events (MACE)

cardiac death, MI, re-PCI, CABG

Time frame: 24 months

Secondary Outcomes

The incidence rate of the major adverse cardiac and cerebrovascular event (MACCE)

non-cardiac death, stroke, hospitalization for acute coronary syndrome

Time frame: 24 months

Data from ClinicalTrials.gov

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