Effects of Combined Therapy With Statin Plus Fenofibrate on Coronary Atherosclerotic Plaque Compared With Statin Alone
Information source: Gachon University Gil Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease
Intervention: Rosuvastatin and fenofibrate (Drug); Rosuvastatin alone (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Gachon University Gil Medical Center Official(s) and/or principal investigator(s): Seung Hwan Han, MD, Principal Investigator, Affiliation: Gachon University Gil Medical Center
Overall contact: Seung Hwan Han, MD, Phone: 82-32-460-3054, Email: shhan@gilhospital.com
Summary
The purpose of this study is to determine effects of combination therapy with rosuvastatin
and fenofibrate on atheromatous plaques and its tissue characteristics of de novo coronary
lesions with intermediate stenosis in patient with coronary artery disease, compared with
rosuvastatin alone therapy.
Clinical Details
Official title: The Comparative Analysis of the Effects on Plaque Volume and Tissue Characteristics Between Combined Therapy With STAatin Plus FENOfibrate and Statin Alone in Mild to Moderate, Non- Intervened Coronary Artery Stenosis (STAFENO Trial)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Absolute changes of Necrotic Core volume
Secondary outcome: Absolute and percent changes of area of necrotic core, dense calcium, fibrofatty, fibrous plaquePresence of thin-cap fibroatheroma Absolute and percent changes of volume/area of external elastic membrane, lumen, plaque Remodeling index Major adverse cardiovascular events (MACE) Adverse drug events Creatine phosphokinase Percent change of Necrotic core volume
Detailed description:
Cardiovascular disease remains the leading cause of morbidity and mortality worldwide. In
the past few decades, optimal pharmacological therapies with statins targeting
LDL-cholesterol substantially reduce the risks of cardiovascular disease. However, the
residual cardiovascular risk is still high, requiring need for additional preventive
therapies to achieve even greater risk reduction.
Recent meta-analysis demonstrated fibrates can reduce the risk of coronary events and might
have a role in patients with high cardiovascular risks or combined dyslipidemia. Likewise,
fenofibrate had a possible benefit for patients with high triglyceride level and low
HDL-cholesterol level in the post-hoc analysis of ACCORD or FIELD trials.
Thus, investigators tried to determine effects of combination therapy with rosuvastatin and
fenofibrate on atheromatous plaques and its tissue characteristics of de novo coronary
lesions with intermediate stenosis in patient with coronary artery disease, compared with
rosuvastatin alone therapy.
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with coronary artery disease who were 20 years of age or older and needed
coronary angiography
- Intermediate coronary artery stenosis (diameter stenosis ≥30% to ≤60% by visual
estimation, diameter ≥2. 0 mm to ≤4. 0 mm, de novo lesion in native coronary artery) in
which virtual histology-intravascular ultrasound (VH-IVUS) could be feasible
- Combined dyslipidemia (LDL-cholesterol ≥70 mg/dL and non-HDL-cholesterol ≥130 mg/dL)
- Patients who gave written informed consent
Exclusion Criteria:
- Patients who had a history of use of lipid-modifying agents within 2 weeks
- Diabetic patients
- Cardiogenic shock
- Heart failure with symptoms of New York Heart Association class III/IV or left
ventricular ejection fraction <35%
- Renal dysfunction (creatinine level ≥1. 7 mg/dL or dependence of dialysis
- Hepatic dysfunction (transaminase level > 3 times of normal within limit)
- Pregnancy or breast-feeding women
- Familial hypercholesterolemia
- Hypertriglyceridemia (triglyceride level >500 mg/dL)
Locations and Contacts
Seung Hwan Han, MD, Phone: 82-32-460-3054, Email: shhan@gilhospital.com
Konyang University Hospital, Daejeon, Korea, Republic of; Not yet recruiting Jang Ho Bae, MD Jang Ho Bae, MD, Principal Investigator
Chonnam National University Medical School and Hospital, Gwangju, Korea, Republic of; Recruiting Young-Joon Hong, MD Young-Joon Hong, MD, Principal Investigator
Inje University ilsanPaik Hospital, Ilsan, Korea, Republic of; Recruiting Sung Yoon Lee, MD Sung Yoon Lee, MD, Principal Investigator
Gachon University Gil Medical Center, Incheon 405-760, Korea, Republic of; Recruiting Seung Hwan Han, MD, PhD, Phone: 82-32-460-3054, Email: shhan@gilhospital.com Seung Hwan Han, MD, Principal Investigator
Chung-Ang University Hospital, Seoul, Korea, Republic of; Recruiting Sang-Wook Kim, MD Sang-Wook Kim, MD, Principal Investigator
Seoul National Univesity Boramae Medical Center, Seoul, Korea, Republic of; Not yet recruiting Sang Hyun Kim, MD Sang Hyun Kim, MD, Principal Investigator
Additional Information
Starting date: January 2014
Last updated: August 10, 2015
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