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Withdrawn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
ConditionsMetabolic Syndrome
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- Withdrawn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.
Investigators
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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