Status:
TERMINATED
the Effect of Febuxostat on Coronary Plaque Volume in Patients With Chronic Stable Angina and Hyperuricemia
Lead Sponsor:
Yokohama City University Medical Center
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2017
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT02279342
Start Date
October 1 2014
End Date
March 31 2017
Last Update
August 3 2017
Active Locations (1)
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1
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan, 232-0024