NCT02069717WithdrawnNot 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 countryStarted: October 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- The incidence rate of the major adverse cardiovascular events (MACE)
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Study Sites (1)
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