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

Withdrawn

• Conditions: Metabolic Syndrome

• Registration Number: NCT02069717
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-02-18
• Study First Submitted QC: 2014-02-20
• Study First Posted: 2014-02-24
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-25
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chonnam national university hospital; 🇰🇷 Gwangju, Korea, Republic of