Clinical trial NCT02232360: Effects of Combined Therapy With Statin Plus Fenofibrate on Coronary Atherosclerotic Plaque Compared With Statin Alone
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Atherosclerotic plaque
Virtual histology intravascular ultrasound
Plaque composition
Rosuvastatin
Fenofibrate
Coronary artery disease
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
Collaborators: name: Daewoong Pharmaceutical Co. LTD.
First posted: 2014-09-05
Enrollment: 106
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

  * Stain-naive patients - LDL-cholesterol ≥70 mg/dL and non-HDL-cholesterol ≥130 mg/dL
  * Patients taking statin within 2 weeks - LDL-cholesterol \< 100 mg/dL and non-HDL-cholesterol ≥100 mg/dL
* Patients who gave written informed consent

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Percent and Absolute changes of Necrotic Core volume in non-culprit intermediate lesions
timeFrame: After 12±2 months treatment
Secondary outcomes:
measure: Percent and Absolute changes of area of necrotic core, dense calcium, fibrous plaque in non-culprit intermediate lesions
timeFrame: After 12±2 months treatment
measure: Presence of thin-cap fibroatheroma
timeFrame: After 12±2 months treatment
measure: Absolute and percent changes of volume/area of external elastic membrane, lumen and plaque volume
timeFrame: After 12±2 months treatment
measure: Remodeling index
timeFrame: After 12±2 months treatment
measure: Major adverse cardiovascular events (MACE)
timeFrame: After 12 months treatment
measure: Adverse drug events
timeFrame: After 12±2 months treatment
measure: Creatine phosphokinase
timeFrame: After 12±2 months treatment
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Konyang University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Medical School and Hospital
city: Ilsan
country: Korea, Republic of
facility: Inje University ilsanPaik Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National Univesity Boramae Medical Center
Study officials:
affiliation: Gachon University Gil Medical Center
name: Seung Hwan Han, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kwon TG, Jang AY, Kim SW, Hong YJ, Bae JH, Lee SY, Kim SH, Han SH. Design and rationale of a randomized control trial testing the effectiveness of combined therapy with STAtin plus FENOfibrate and statin alone in non-diabetic, combined dyslipidemia patients with non-intervened intermediate coronary artery disease - STAFENO study. Trials. 2020 Apr 22;21(1):353. doi: 10.1186/s13063-020-04291-5.