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| Name | Class |
|---|---|
| Daewoong Pharmaceutical Co. LTD. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin and fenofibrate | Experimental | Combination therapy: rosuvastatin 10 mg and fenofibrate 160 mg per day |
|
| Rosuvastatin alone | Active Comparator | Rosuvastatin 10 mg per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin and fenofibrate | Drug | Combination therapy: rosuvastatin 10 mg and fenofibrate 160 mg per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | After 12±2 months treatment |
| Presence of thin-cap fibroatheroma |
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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
Patients who gave written informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seung Hwan Han, MD | Contact | 82-32-460-3054 | shhan@gilhospital.com | |
| Pyung Chun Oh, MD | Contact | 82-32-460-3054 | likemed@gilhospital.com |
| Name | Affiliation | Role |
|---|---|---|
| Seung Hwan Han, MD | Gachon University Gil Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konyang University Hospital | Not yet recruiting | Daejeon | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32321551 | Derived | 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. |
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| Rosuvastatin alone | Drug | Rosuvastatin 10mg per day |
|
|
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 | 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 | Remodeling index by VH-IVUS | 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 | After 12 months treatment |
| Adverse drug events | Adverse drug events related by study drugs | After 12±2 months treatment |
| Creatine phosphokinase | measurement of muscular side effects related by study drugs | After 12±2 months treatment |
| Chonnam National University Medical School and Hospital | Recruiting | Gwangju | South Korea |
|
| Inje University ilsanPaik Hospital | Recruiting | Ilsan | South Korea |
|
| Gachon University Gil Medical Center | Recruiting | Incheon | 405-760 | South Korea |
|
| Chung-Ang University Hospital | Recruiting | Seoul | South Korea |
|
| Seoul National Univesity Boramae Medical Center | Not yet recruiting | Seoul | South Korea |
|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D058226 | Plaque, Atherosclerotic |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D011345 | Fenofibrate |
| D003131 | Combined Modality Therapy |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D010636 | Phenols |
| D007659 | Ketones |
| D013812 | Therapeutics |
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