Observational Study to Assess the Incidence Rate of the Major Adverse Cardiovascular Events (MACE) and Safety of Fenofibrate (Lipilfen Capsule)
Withdrawn
- Conditions
- Metabolic Syndrome
- Interventions
- Other: Not applicable-observational study
- 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
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- WITHDRAWN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
- Arm && Interventions
Group Intervention Description Not applicable-observational study Not applicable-observational study Not applicable-observational study
- 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms mediate fenofibrate's cardiovascular risk reduction in metabolic syndrome patients post-MI?
How does fenofibrate add-on therapy compare to standard lipid-lowering regimens in preventing MACE in post-MI metabolic syndrome patients?
Which biomarkers correlate with improved outcomes in fenofibrate-treated metabolic syndrome patients with prior MI?
What adverse event profiles are associated with fenofibrate-statin combinations in high-risk cardiovascular populations?
What are the competitive advantages of Daewoong's fenofibrate formulation versus other fibrates in metabolic syndrome management?
Trial Locations
- Locations (1)
Chonnam national university hospital
🇰🇷Gwangju, Korea, Republic of