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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Daewoong Pharmaceutical Co. LTD.
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT02069717
First received: February 18, 2014
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Other: Not applicable-observational study

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
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

Resource links provided by NLM:


Further study details as provided by Daewoong Pharmaceutical Co. LTD.:

Primary Outcome Measures:
  • The incidence rate of the major adverse cardiovascular events (MACE) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    cardiac death, MI, re-PCI, CABG


Secondary Outcome Measures:
  • The incidence rate of the major adverse cardiac and cerebrovascular event (MACCE) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    non-cardiac death, stroke, hospitalization for acute coronary syndrome


Estimated Enrollment: 1573
Study Start Date: October 2013
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Not applicable-observational study
Not applicable-observational study
Other: Not applicable-observational study

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects aged more than 20 with history of acute myocardial infarction and diagnosed with metabolic syndrome

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02069717

Locations
Korea, Republic of
Chonnam national university hospital Recruiting
Gwangju, Korea, Republic of, 501-757
Contact: Myung Ho Jeong, MD, PhD       shj@daewoong.co.kr   
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
  More Information

No publications provided

Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT02069717     History of Changes
Other Study ID Numbers: DW_FAMI_001
Study First Received: February 18, 2014
Last Updated: February 20, 2014
Health Authority: Korea: Ministry of Food and Drug Safety

Additional relevant MeSH terms:
Myocardial Infarction
Metabolic Syndrome X
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014