the Effect of Febuxostat on Coronary Plaque Volume in Patients With Chronic Stable Angina and Hyperuricemia

Sponsor

Yokohama City University Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT02279342

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: Febuxostat	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

the Effect of Febuxostat on Coronary Plaque Volume in Patients With Chronic Stable Angina and Hyperuricemia

Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Mar 31, 2017

Actual Study Completion Date :

Mar 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Non febuxostat treatment group No febuxostat treatment
Experimental: Febuxostat treatment group once daily after breakfast	Drug: Febuxostat 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.

Arm

Intervention/Treatment

No Intervention: Non febuxostat treatment group

No febuxostat treatment

Experimental: Febuxostat treatment group

once daily after breakfast

Drug: Febuxostat

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.

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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