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

• Status: Terminated
• Trial end date: 2017-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yokohama City University Medical Center
• Treatments: Febuxostat

Criteria

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.