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

Phase 4

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Drug: Febuxostat

• Registration Number: NCT02279342
• Lead Sponsor: Yokohama City University Medical Center

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.

Study Timeline

• Study First Submitted: 2014-08-14
• Study Start: 2014-10
• Study First Submitted QC: 2014-10-30
• Study First Posted: 2014-10-31
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-02
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Febuxostat treatment group	Febuxostat	once daily after breakfast

Primary Outcome Measures

Name	Time	Method
The percent changes in integrated backscatter signal obtained by integrated backscatter IVUS from baseline to follow up	8-12
The percent changes in coronary plaque volume obtained by IVUS from baseline to follow up	8-12 months

Secondary Outcome Measures

Name	Time	Method
changes in serum uremic values and inflammatory markers from baseline to follow up	8-12 months
prognosis(death, ACS, restenosis)	8-12 months
changes in plaque characteristics assessed 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
absolute changes of coronary plaque volume by IVUS from baseline to follow up	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

Trial Locations

Locations (1)

Yokohama City University Medical Center; 🇯🇵 Yokohama, Kanagawa, Japan