- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02232360
Effects of Combined Therapy With Statin Plus Fenofibrate on Coronary Atherosclerotic Plaque Compared With Statin Alone
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Seung Hwan Han, MD
- Phone Number: 82-32-460-3054
- Email: shhan@gilhospital.com
Study Contact Backup
- Name: Pyung Chun Oh, MD
- Phone Number: 82-32-460-3054
- Email: likemed@gilhospital.com
Study Locations
-
-
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Daejeon, Korea, Republic of
- Not yet recruiting
- Konyang University Hospital
-
Contact:
- Jang Ho Bae, MD
-
Principal Investigator:
- Jang Ho Bae, MD
-
Gwangju, Korea, Republic of
- Recruiting
- Chonnam National University Medical School and Hospital
-
Contact:
- Young-joon Hong, MD
-
Principal Investigator:
- Young-joon Hong, MD
-
Ilsan, Korea, Republic of
- Recruiting
- Inje University ilsanPaik Hospital
-
Contact:
- Sung Yoon Lee, MD
-
Principal Investigator:
- Sung Yoon Lee, MD
-
Incheon, Korea, Republic of, 405-760
- Recruiting
- Gachon University Gil Medical Center
-
Contact:
- Seung Hwan Han, MD, PhD
- Phone Number: 82-32-460-3054
- Email: shhan@gilhospital.com
-
Principal Investigator:
- Seung Hwan Han, MD
-
Seoul, Korea, Republic of
- Recruiting
- Chung-Ang University Hospital
-
Contact:
- Sang-wook Kim, MD
-
Principal Investigator:
- Sang-wook Kim, MD
-
Seoul, Korea, Republic of
- Not yet recruiting
- Seoul National Univesity Boramae Medical Center
-
Contact:
- Sang Hyun Kim, MD
-
Principal Investigator:
- Sang Hyun Kim, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rosuvastatin and fenofibrate
Combination therapy: rosuvastatin 10 mg and fenofibrate 160 mg per day
|
Combination therapy: rosuvastatin 10 mg and fenofibrate 160 mg per day
Other Names:
|
Active Comparator: Rosuvastatin alone
Rosuvastatin 10 mg per day
|
Rosuvastatin 10mg per day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent and Absolute changes of Necrotic Core volume in non-culprit intermediate lesions
Time Frame: After 12±2 months treatment
|
Percent and Absolute changes of Necrotic Core volume in non-culprit intermediate lesions by VH-IVUS
|
After 12±2 months treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent and Absolute changes of area of necrotic core, dense calcium, fibrous plaque in non-culprit intermediate lesions
Time Frame: After 12±2 months treatment
|
Percent and Absolute changes of area of necrotic core, dense calcium, fibrous plaque in non-culprit intermediate lesions by VH-IVUS
|
After 12±2 months treatment
|
Presence of thin-cap fibroatheroma
Time Frame: After 12±2 months treatment
|
change of plaque phenotype by VH-IVUS
|
After 12±2 months treatment
|
Absolute and percent changes of volume/area of external elastic membrane, lumen and plaque volume
Time Frame: After 12±2 months treatment
|
Absolute and percent changes of volume/area of external elastic membrane, lumen and plaque volume by VH-IVUS
|
After 12±2 months treatment
|
Remodeling index
Time Frame: After 12±2 months treatment
|
Remodeling index by VH-IVUS
|
After 12±2 months treatment
|
Major adverse cardiovascular events (MACE)
Time Frame: After 12 months treatment
|
The composites of all-cause death, non-fatal myocardial infarction, stroke, culprit lesion revascularization, or non-culprit lesion revascularization
|
After 12 months treatment
|
Adverse drug events
Time Frame: After 12±2 months treatment
|
Adverse drug events related by study drugs
|
After 12±2 months treatment
|
Creatine phosphokinase
Time Frame: After 12±2 months treatment
|
measurement of muscular side effects related by study drugs
|
After 12±2 months treatment
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Seung Hwan Han, MD, Gachon University Gil Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Rosuvastatin Calcium
- Fenofibrate
Other Study ID Numbers
- STAFENO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
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IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
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National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
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Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
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Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
-
China National Center for Cardiovascular DiseasesRecruitingLeft Main Coronary Artery DiseaseChina
Clinical Trials on Rosuvastatin and fenofibrate
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University of Campania "Luigi Vanvitelli"Unknown
-
National Taiwan University HospitalAvailable
-
National Taiwan University HospitalAvailableHyperlipidemia
-
University of IoanninaUnknown
-
IlDong Pharmaceutical Co LtdCompletedMixed DyslipidemiasKorea, Republic of
-
AstraZenecaCompleted
-
Ranbaxy Laboratories LimitedCompleted
-
Gachon University Gil Medical CenterCompletedHypertriglyceridemiaKorea, Republic of
-
Zhejiang UniversityCompletedHyperlipoproteinemiaChina