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TerminatedNCT02279342Updated Aug 3, 2017

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

A Phase 4 interventional study of Febuxostat in Coronary Artery Disease, sponsored by Yokohama City University Medical Center. Terminated at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-08-03.

Sponsored by Yokohama City University Medical Center · Phase 4, Interventional, and Treatment

Why this study was terminated
Entry were insufficient as expected.
Phase
Phase 4
Study type
Interventional
Enrollment
1
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Coronary artery disease
  • hyperuricemia
  • coronary plaque volume
  • IVUS
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 1 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Yokohama City University Medical Center is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • No intervention
    Non febuxostat treatment group

    No febuxostat treatment

  • Experimental
    Febuxostat treatment group

    once daily after breakfast

    Drug: Febuxostat

Interventions

  • DrugFebuxostat

    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.

06

What researchers measure

Primary outcomes

  1. The percent changes in coronary plaque volume obtained by IVUS from baseline to follow up

    Time frame: 8-12 months

  2. The percent changes in integrated backscatter signal obtained by integrated backscatter IVUS from baseline to follow up

    Time frame: 8-12

Secondary outcomes

  1. absolute changes of coronary plaque volume by IVUS from baseline to follow up

    Time frame: 8-12 months

  2. absolute and percent changes in minimal lumen diameter and percent stenosis by QCA from baseline to follow up

    Time frame: 8-12 months

  3. changes in plaque characteristics assessed by IVUS from baseline to follow up

    Time frame: 8-12 months

  4. changes in serum uremic values and inflammatory markers from baseline to follow up

    Time frame: 8-12 months

  5. prognosis(death, ACS, restenosis)

    Time frame: 8-12 months

  6. nominal changes in plaque burden assessed by IVUS from baseline to follow up

    Time frame: 8-12 months

  7. nominal changes in plaque burden adjusting for analyzed length assessed by IVUS from baseline to follow up

    Time frame: 8-12 months

07

Study locations

1 site
  • Yokohama City University Medical Center
    Yokohama, Kanagawa 232-0024, Japan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02279342
Lead sponsor
Yokohama City University Medical Center
Responsible party
Kiyoshi Hibi (associate professor of medicine, Yokohama City University Medical Center) — Principal investigator
First posted
Oct 31, 2014
Start date
Oct 2014
Primary completion
Mar 31, 2017
Completion
Mar 31, 2017
Last update
Aug 3, 2017

Study contacts

Kiyoshi Hibi, MD
study chair · Yokohama City University Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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