Coronary Artery DiseasePhase 4NCT02232360
Effects of Combined Therapy With Statin Plus Fenofibrate on Coronary Atherosclerotic Plaque Compared With Statin Alone
A Phase 4 study testing Rosuvastatin and fenofibrate and Rosuvastatin alone in people with Coronary Artery Disease, run by Gachon University Gil Medical Center at 6 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Rosuvastatin and fenofibrate and Rosuvastatin alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Jan 2014to Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites, 6 recruiting
- Not yet recruiting
Konyang University Hospital
Daejeon
Jang Ho Bae, MD
Jang Ho Bae, MD
- Recruiting
Chonnam National University Medical School and Hospital
Gwangju
Young-Joon Hong, MD
Young-Joon Hong, MD
- Recruiting
Inje University ilsanPaik Hospital
Ilsan
Sung Yoon Lee, MD
Sung Yoon Lee, MD
- Recruiting
Gachon University Gil Medical Center
Incheon, 405-760
Seung Hwan Han, MD, PhD, 82-32-460-3054, shhan@gilhospital.com
Seung Hwan Han, MD
- Recruiting
Chung-Ang University Hospital
Seoul
Sang-Wook Kim, MD
Sang-Wook Kim, MD
- Not yet recruiting
Seoul National Univesity Boramae Medical Center
Seoul
Sang Hyun Kim, MD
Sang Hyun Kim, MD
About this study
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)
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Rosuvastatin and fenofibrate, Rosuvastatin alone
- Keywords
- Atherosclerotic plaque, Virtual histology intravascular ultrasound, Plaque composition, Rosuvastatin, Fenofibrate, Coronary artery disease
- Medical subject headings
- Coronary Artery Disease, Plaque, Atherosclerotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin and fenofibrateDrug
Also called Combination therapy with rosuvastatin and fenofibrate
Combination therapy: rosuvastatin 10 mg and fenofibrate 160 mg per day
Rosuvastatin aloneDrug
Also called Rosuvastatin alone therapy
Rosuvastatin 10mg per day
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin and fenofibrate | Experimental | Combination therapy: rosuvastatin 10 mg and fenofibrate 160 mg per day Receives: Drug: Rosuvastatin and fenofibrate |
| Rosuvastatin alone | Active comparator | Rosuvastatin 10 mg per day Receives: Drug: Rosuvastatin alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Percent and Absolute changes of area of necrotic core, dense calcium, fibrous plaque in non-culprit intermediate lesions by VH-IVUS
Measured: After 12±2 months treatment
Presence of thin-cap fibroatheroma
change of plaque phenotype by VH-IVUS
Measured: After 12±2 months treatment
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
Measured: After 12±2 months treatment
Remodeling index
Remodeling index by VH-IVUS
Measured: After 12±2 months treatment
Major adverse cardiovascular events (MACE)
The composites of all-cause death, non-fatal myocardial infarction, stroke, culprit lesion revascularization, or non-culprit lesion revascularization
Measured: After 12 months treatment
Adverse drug events
Adverse drug events related by study drugs
Measured: After 12±2 months treatment
Creatine phosphokinase
measurement of muscular side effects related by study drugs
Measured: After 12±2 months treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Responsible party
- Principal investigator, Seung Hwan Han, Gachon University Gil Medical Center
- Investigators
- Seung Hwan Han, MD, Principal investigator, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232360
- Sponsor's protocol ID
- STAFENO
- Status last verified
- May 2019
- First submitted
- 2 Sep 2014
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32321551
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02232360
- Acronym / sponsor ID
- STAFENO
- Conditions
- Coronary Artery Disease
- Keywords
- Atherosclerotic plaque, Virtual histology intravascular ultrasound, Plaque composition, Rosuvastatin, Fenofibrate, Coronary artery disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Study start
- Jan 2014
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 5 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin and fenofibrate | Experimental | Drug: Rosuvastatin and fenofibrateCombination therapy: rosuvastatin 10 mg and fenofibrate 160 mg per day |
| Rosuvastatin alone | Active comparator | Drug: Rosuvastatin aloneRosuvastatin 10 mg per day |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Patients who gave written informed consent
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatin and fenofibrateAlso: Combination therapy with rosuvastatin and fenofibrateCombination therapy: rosuvastatin 10 mg and fenofibrate 160 mg per day | Drug | Rosuvastatin and fenofibrate |
| Rosuvastatin aloneAlso: Rosuvastatin alone therapyRosuvastatin 10mg per day | Drug | Rosuvastatin alone |
Primary outcome
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
7 secondary outcomes
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
Presence of thin-cap fibroatheroma
Time frame: 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
Remodeling index
Time frame: After 12±2 months treatment
Major adverse cardiovascular events (MACE)
Time frame: After 12 months treatment
Adverse drug events
Time frame: After 12±2 months treatment
Creatine phosphokinase
Time frame: After 12±2 months treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Derived from this study: PubMed 32321551Kwon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung Hwan Han, MD principal investigator
Gachon University Gil Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin and fenofibrate and Rosuvastatin alone in people with Coronary Artery Disease, run by Gachon University Gil Medical Center at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seung Hwan Han, MD (82-32-460-3054, shhan@gilhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent and Absolute changes of Necrotic Core volume in non-culprit intermediate lesions (time frame: After 12±2 months treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02232360, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.