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

Yokohama City University Medical Center

Status and phase: Terminated; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Febuxostat

Study type: Interventional

Funder types: Other

Identifiers

NCT02279342

D1407027

Details and patient eligibility

About

The purpose of this study is to investigate the effects of febuxostat on coronary plaque volume in patients with chronic stable angina and hyperuricemia.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Non febuxostat treatment group

No Intervention group

Description:

No febuxostat treatment

Febuxostat treatment group

Experimental group

Description:

once daily after breakfast

Treatment:

Drug: Febuxostat