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Effects of Combined Therapy With Statin Plus Fenofibrate on Coronary Atherosclerotic Plaque Compared With Statin Alone

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rosuvastatin and fenofibrate
Rosuvastatin alone
Sponsored by
Gachon University Gil Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Atherosclerotic plaque, Virtual histology intravascular ultrasound, Plaque composition, Rosuvastatin, Fenofibrate, Coronary artery disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Konyang University Hospital
  • Chonnam National University Medical School and HospitalRecruiting
  • Inje University ilsanPaik HospitalRecruiting
  • Gachon University Gil Medical CenterRecruiting
  • Chung-Ang University HospitalRecruiting
  • Seoul National Univesity Boramae Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rosuvastatin and fenofibrate

Rosuvastatin alone

Arm Description

Combination therapy: rosuvastatin 10 mg and fenofibrate 160 mg per day

Rosuvastatin 10 mg per day

Outcomes

Primary Outcome Measures

Percent and Absolute changes of Necrotic Core volume in non-culprit intermediate lesions
Percent and Absolute changes of Necrotic Core volume in non-culprit intermediate lesions by VH-IVUS

Secondary Outcome Measures

Percent and Absolute changes of area of necrotic core, dense calcium, fibrous plaque in non-culprit intermediate lesions
Percent and Absolute changes of area of necrotic core, dense calcium, fibrous plaque in non-culprit intermediate lesions by VH-IVUS
Presence of thin-cap fibroatheroma
change of plaque phenotype by VH-IVUS
Absolute and percent changes of volume/area of external elastic membrane, lumen and plaque volume
Absolute and percent changes of volume/area of external elastic membrane, lumen and plaque volume by VH-IVUS
Remodeling index
Remodeling index by VH-IVUS
Major adverse cardiovascular events (MACE)
The composites of all-cause death, non-fatal myocardial infarction, stroke, culprit lesion revascularization, or non-culprit lesion revascularization
Adverse drug events
Adverse drug events related by study drugs
Creatine phosphokinase
measurement of muscular side effects related by study drugs

Full Information

First Posted
September 2, 2014
Last Updated
May 12, 2019
Sponsor
Gachon University Gil Medical Center
Collaborators
Daewoong Pharmaceutical Co. LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT02232360
Brief Title
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gachon University Gil Medical Center
Collaborators
Daewoong Pharmaceutical Co. LTD.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Atherosclerotic plaque, Virtual histology intravascular ultrasound, Plaque composition, Rosuvastatin, Fenofibrate, Coronary artery disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rosuvastatin and fenofibrate
Arm Type
Experimental
Arm Description
Combination therapy: rosuvastatin 10 mg and fenofibrate 160 mg per day
Arm Title
Rosuvastatin alone
Arm Type
Active Comparator
Arm Description
Rosuvastatin 10 mg per day
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin and fenofibrate
Other Intervention Name(s)
Combination therapy with rosuvastatin and fenofibrate
Intervention Description
Combination therapy: rosuvastatin 10 mg and fenofibrate 160 mg per day
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin alone
Other Intervention Name(s)
Rosuvastatin alone therapy
Intervention Description
Rosuvastatin 10mg per day
Primary Outcome Measure Information:
Title
Percent and Absolute changes of Necrotic Core volume in non-culprit intermediate lesions
Description
Percent and Absolute changes of Necrotic Core volume in non-culprit intermediate lesions by VH-IVUS
Time Frame
After 12±2 months treatment
Secondary Outcome Measure Information:
Title
Percent and Absolute changes of area of necrotic core, dense calcium, fibrous plaque in non-culprit intermediate lesions
Description
Percent and Absolute changes of area of necrotic core, dense calcium, fibrous plaque in non-culprit intermediate lesions by VH-IVUS
Time Frame
After 12±2 months treatment
Title
Presence of thin-cap fibroatheroma
Description
change of plaque phenotype by VH-IVUS
Time Frame
After 12±2 months treatment
Title
Absolute and percent changes of volume/area of external elastic membrane, lumen and plaque volume
Description
Absolute and percent changes of volume/area of external elastic membrane, lumen and plaque volume by VH-IVUS
Time Frame
After 12±2 months treatment
Title
Remodeling index
Description
Remodeling index by VH-IVUS
Time Frame
After 12±2 months treatment
Title
Major adverse cardiovascular events (MACE)
Description
The composites of all-cause death, non-fatal myocardial infarction, stroke, culprit lesion revascularization, or non-culprit lesion revascularization
Time Frame
After 12 months treatment
Title
Adverse drug events
Description
Adverse drug events related by study drugs
Time Frame
After 12±2 months treatment
Title
Creatine phosphokinase
Description
measurement of muscular side effects related by study drugs
Time Frame
After 12±2 months treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seung Hwan Han, MD
Phone
82-32-460-3054
Email
shhan@gilhospital.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pyung Chun Oh, MD
Phone
82-32-460-3054
Email
likemed@gilhospital.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung Hwan Han, MD
Organizational Affiliation
Gachon University Gil Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Konyang University Hospital
City
Daejeon
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jang Ho Bae, MD
First Name & Middle Initial & Last Name & Degree
Jang Ho Bae, MD
Facility Name
Chonnam National University Medical School and Hospital
City
Gwangju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young-Joon Hong, MD
First Name & Middle Initial & Last Name & Degree
Young-Joon Hong, MD
Facility Name
Inje University ilsanPaik Hospital
City
Ilsan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung Yoon Lee, MD
First Name & Middle Initial & Last Name & Degree
Sung Yoon Lee, MD
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung Hwan Han, MD, PhD
Phone
82-32-460-3054
Email
shhan@gilhospital.com
First Name & Middle Initial & Last Name & Degree
Seung Hwan Han, MD
Facility Name
Chung-Ang University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang-Wook Kim, MD
First Name & Middle Initial & Last Name & Degree
Sang-Wook Kim, MD
Facility Name
Seoul National Univesity Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Hyun Kim, MD
First Name & Middle Initial & Last Name & Degree
Sang Hyun Kim, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
32321551
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.
Results Reference
derived

Learn more about this trial

Effects of Combined Therapy With Statin Plus Fenofibrate on Coronary Atherosclerotic Plaque Compared With Statin Alone

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