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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 plaque

Presence 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

Page last updated: August 23, 2015

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