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

NCT02232360 | Unknown Phase 4 DMC

• 1 other identifier: STAFENO
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 6

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.

Conditions

Coronary Artery Disease

Keywords

Atherosclerotic plaque; Virtual histology intravascular ultrasound; Plaque composition; Rosuvastatin; Fenofibrate; Coronary artery disease

Outcome Measures

Primary Outcomes (1)

• 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

  After 12±2 months treatment

Secondary Outcomes (7)

• Percent and Absolute changes of area of necrotic core, dense calcium, fibrous plaque in non-culprit intermediate lesions

  After 12±2 months treatment

• Presence of thin-cap fibroatheroma

  After 12±2 months treatment

• Absolute and percent changes of volume/area of external elastic membrane, lumen and plaque volume

  After 12±2 months treatment

• Remodeling index

  After 12±2 months treatment

• Major adverse cardiovascular events (MACE)

  After 12 months treatment

Study Arms (2)

Rosuvastatin and fenofibrate

EXPERIMENTAL

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

Drug: Rosuvastatin and fenofibrate

Rosuvastatin alone

ACTIVE COMPARATOR

Rosuvastatin 10 mg per day

Drug: Rosuvastatin alone

Interventions

Rosuvastatin and fenofibrate DRUG

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

Also known as: Combination therapy with rosuvastatin and fenofibrate

Rosuvastatin and fenofibrate

Rosuvastatin alone DRUG

Rosuvastatin 10mg per day

Also known as: Rosuvastatin alone therapy

Rosuvastatin alone

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gachon University Gil Medical Center: lead
• Daewoong Pharmaceutical Co. LTD.: collaborator

Study Sites (6)

Konyang University Hospital

Daejeon, South Korea

NOT YET RECRUITING

Chonnam National University Medical School and Hospital

Gwangju, South Korea

RECRUITING

Inje University ilsanPaik Hospital

Ilsan, South Korea

RECRUITING

Gachon University Gil Medical Center

Incheon, 405-760, South Korea

RECRUITING

Chung-Ang University Hospital

Seoul, South Korea

RECRUITING

Seoul National Univesity Boramae Medical Center

Seoul, South Korea

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 32321551 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Plaque, Atherosclerotic

Interventions

Rosuvastatin Calcium; Fenofibrate; Combined Modality Therapy

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Phenols; Ketones; Therapeutics

Study Officials

• Seung Hwan Han, MD

  Gachon University Gil Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung Hwan Han, MD

CONTACT

82-32-460-3054; shhan@gilhospital.com

Pyung Chun Oh, MD

CONTACT

82-32-460-3054; likemed@gilhospital.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 5, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 15, 2019

Record last verified: 2019-05

Locations

KR (6)