Back to resultsthe Effect of Febuxostat on Coronary Plaque Volume in Patients With Chronic Stable Angina and Hyperuricemia
Primary Purpose
Coronary Artery Disease
Status
Terminated
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Febuxostat
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery disease, hyperuricemia, coronary plaque volume, IVUS
Eligibility Criteria
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.
Sites / Locations
- Yokohama City University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Non febuxostat treatment group
Febuxostat treatment group
Arm Description
No febuxostat treatment
once daily after breakfast
Outcomes
Primary Outcome Measures
The percent changes in coronary plaque volume obtained by IVUS from baseline to follow up
The percent changes in integrated backscatter signal obtained by integrated backscatter IVUS from baseline to follow up
Secondary Outcome Measures
absolute changes of coronary plaque volume by IVUS from baseline to follow up
absolute and percent changes in minimal lumen diameter and percent stenosis by QCA from baseline to follow up
changes in plaque characteristics assessed by IVUS from baseline to follow up
changes in serum uremic values and inflammatory markers from baseline to follow up
prognosis(death, ACS, restenosis)
nominal changes in plaque burden assessed by IVUS from baseline to follow up
nominal changes in plaque burden adjusting for analyzed length assessed by IVUS from baseline to follow up
Full Information
NCT ID
NCT02279342
First Posted
August 14, 2014
Last Updated
August 2, 2017
Sponsor
Yokohama City University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02279342
Brief Title
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
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Entry were insufficient as expected.
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
March 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yokohama City University Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease, hyperuricemia, coronary plaque volume, IVUS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non febuxostat treatment group
Arm Type
No Intervention
Arm Description
No febuxostat treatment
Arm Title
Febuxostat treatment group
Arm Type
Experimental
Arm Description
once daily after breakfast
Intervention Type
Drug
Intervention Name(s)
Febuxostat
Intervention Description
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.
Primary Outcome Measure Information:
Title
The percent changes in coronary plaque volume obtained by IVUS from baseline to follow up
Time Frame
8-12 months
Title
The percent changes in integrated backscatter signal obtained by integrated backscatter IVUS from baseline to follow up
Time Frame
8-12
Secondary Outcome Measure Information:
Title
absolute changes of coronary plaque volume by IVUS from baseline to follow up
Time Frame
8-12 months
Title
absolute and percent changes in minimal lumen diameter and percent stenosis by QCA from baseline to follow up
Time Frame
8-12 months
Title
changes in plaque characteristics assessed by IVUS from baseline to follow up
Time Frame
8-12 months
Title
changes in serum uremic values and inflammatory markers from baseline to follow up
Time Frame
8-12 months
Title
prognosis(death, ACS, restenosis)
Time Frame
8-12 months
Title
nominal changes in plaque burden assessed by IVUS from baseline to follow up
Time Frame
8-12 months
Title
nominal changes in plaque burden adjusting for analyzed length assessed by IVUS from baseline to follow up
Time Frame
8-12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiyoshi Hibi, MD
Organizational Affiliation
Yokohama City University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Yokohama City University Medical Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
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