NCT02279342

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_4 coronary-artery-disease

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
Last Updated

August 3, 2017

Status Verified

August 1, 2017

Enrollment Period

2.5 years

First QC Date

August 14, 2014

Last Update Submit

August 2, 2017

Conditions

Coronary Artery Disease

Keywords

Coronary artery diseasehyperuricemiacoronary plaque volumeIVUS

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Non febuxostat treatment group

NO INTERVENTION

No febuxostat treatment

Febuxostat treatment group

EXPERIMENTAL

once daily after breakfast

Drug: Febuxostat

Interventions

FebuxostatDRUG

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.

Febuxostat treatment group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yokohama City University Medical Center

Yokohama, Kanagawa, 232-0024, Japan

Location

MeSH Terms

Conditions

Coronary Artery DiseaseHyperuricemia

Interventions

Febuxostat

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Kiyoshi Hibi, MD

    Yokohama City University Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor of medicine

Study Record Dates

First Submitted

August 14, 2014

First Posted

October 31, 2014

Study Start

October 1, 2014

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

August 3, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)