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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02069717
• Other study ID #: DW_FAMI_001
• Status: Withdrawn
• Phase: N/A
• First received: February 18, 2014
• Last updated: October 25, 2016
• Start date: October 2013
• Est. completion date: September 2014

Study information

• Verified date: October 2016
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Other:
• Not applicable-observational study

Locations

Country	Name	City	State
Korea, Republic of	Chonnam national university hospital	Gwangju

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence rate of the major adverse cardiovascular events (MACE)	cardiac death, MI, re-PCI, CABG	24 months	Yes
Secondary	The incidence rate of the major adverse cardiac and cerebrovascular event (MACCE)	non-cardiac death, stroke, hospitalization for acute coronary syndrome	24 months	Yes