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Clinical Trials/NCT02069717
NCT02069717
Withdrawn
Not Applicable

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

Daewoong Pharmaceutical Co. LTD.1 site in 1 countryOctober 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metabolic Syndrome
Sponsor
Daewoong Pharmaceutical Co. LTD.
Locations
1
Primary Endpoint
The incidence rate of the major adverse cardiovascular events (MACE)
Status
Withdrawn
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
September 2014
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Daewoong Pharmaceutical Co. LTD.
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 24 months

cardiac death, MI, re-PCI, CABG

Secondary Outcomes

  • The incidence rate of the major adverse cardiac and cerebrovascular event (MACCE)(24 months)

Study Sites (1)

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