Clinical trial NCT02279342: the Effect of Febuxostat on Coronary Plaque Volume in Patients With Chronic Stable Angina and Hyperuricemia
Official title: the Effect of Febuxostat on Coronary Plaque Volume in Patients With Chronic Stable Angina and Hyperuricemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
hyperuricemia
coronary plaque volume
IVUS
Lead sponsor: Yokohama City University Medical Center
Sponsor class: OTHER
First posted: 2014-10-31
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of febuxostat on coronary plaque volume in patients with chronic stable angina and hyperuricemia.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients 20 years of age or older at enrollment who are able to visit
2. Patients with chronic stable angina who have severe coronary stenosis wich require PCI.
3. Patients who have at least one coronary plaque (≧ 500μm in thickness or % plaque of 20% or more) at the non-culprit vessels.
4. Patients with hyperuricemia, who have a serum uric acid level \>7.0mg/dL within 2 months prior to enrollement.
5. Patients who personally given written informed consent to participate in this study.

Exclusion Criteria:

1. Patients who had undergone previous PCI for the lesion under investigation.
2. Patients with gouty tophus, or patients with subjective symptoms of gouty arthritis within 1 year prior to enrollment.
3. Patients with a previous history of hypersensitivity to febuxostat or allopurinol.
4. Patients with serious kidney disease, Acute kidney disease, nephrotic syndrome, dialysis patients, kidney transplant patients, eGFR \< 30 mL/min/1.73m2, etc.
5. Patients with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 2 or more times the upper limit of normal.
6. Patients on any of the following medications at enrollment Mercaptopurine hydrate, azathioprine, vidarabine, or didanosine.
7. Patients who receive any of the following medications for the treatment of hyperuricemia within 1 month prior to enrollment Allopurinol, benzbromarone, probenecid, bucolome, topiroxostat, or febuxostat.
8. Patients otherwise judged by the principal or sub-investigator to be unsuitable for the study.

Primary outcomes:
measure: The percent changes in coronary plaque volume obtained by IVUS from baseline to follow up
timeFrame: 8-12 months
measure: The percent changes in integrated backscatter signal obtained by integrated backscatter IVUS from baseline to follow up
timeFrame: 8-12
Secondary outcomes:
measure: absolute changes of coronary plaque volume by IVUS from baseline to follow up
timeFrame: 8-12 months
measure: absolute and percent changes in minimal lumen diameter and percent stenosis by QCA from baseline to follow up
timeFrame: 8-12 months
measure: changes in plaque characteristics assessed by IVUS from baseline to follow up
timeFrame: 8-12 months
measure: changes in serum uremic values and inflammatory markers from baseline to follow up
timeFrame: 8-12 months
measure: prognosis(death, ACS, restenosis)
timeFrame: 8-12 months
measure: nominal changes in plaque burden assessed by IVUS from baseline to follow up
timeFrame: 8-12 months
measure: nominal changes in plaque burden adjusting for analyzed length assessed by IVUS from baseline to follow up
timeFrame: 8-12 months
Other outcomes:
Locations:
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
Study officials:
affiliation: Yokohama City University Medical Center
name: Kiyoshi Hibi, MD
role: STUDY_CHAIR
References: