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The purpose of this study is to investigate the effects of febuxostat on coronary plaque volume in patients with chronic stable angina and hyperuricemia.
Patients with stable angina and hyperuricemia who undergo percutaneous coronary intervention (PCI) with intravascular ultrasound (IVUS) are enrolled. Participants will be randomly assigned to one of the two treatment groups.
Febuxostat group and A lifestyle modification group. At 8-12 months, routine follow up angiography and IVUS interrogation as well as endothelial function and several bio markers will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non febuxostat treatment group | No Intervention | No febuxostat treatment | |
| Febuxostat treatment group | Experimental | once daily after breakfast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Febuxostat | Drug | The starting dose of the febuxostat will be 10mg /day. The dose will be increased to 20 mg/day at week 4 and finally titrated to 40 mg/day at week 8. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The percent changes in coronary plaque volume obtained by IVUS from baseline to follow up | 8-12 months | |
| The percent changes in integrated backscatter signal obtained by integrated backscatter IVUS from baseline to follow up | 8-12 |
| Measure | Description | Time Frame |
|---|---|---|
| absolute changes of coronary plaque volume by IVUS from baseline to follow up | 8-12 months | |
| absolute and percent changes in minimal lumen diameter and percent stenosis by QCA from baseline to follow up | 8-12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kiyoshi Hibi, MD | Yokohama City University Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yokohama City University Medical Center | Yokohama | Kanagawa | 232-0024 | Japan |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069465 | Febuxostat |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| changes in plaque characteristics assessed by IVUS from baseline to follow up | 8-12 months |
| changes in serum uremic values and inflammatory markers from baseline to follow up | 8-12 months |
| prognosis(death, ACS, restenosis) | 8-12 months |
| nominal changes in plaque burden assessed by IVUS from baseline to follow up | 8-12 months |
| nominal changes in plaque burden adjusting for analyzed length assessed by IVUS from baseline to follow up | 8-12 months |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |