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

NCT ID: NCT02279342

Last Updated: 2017-08-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-03-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Non febuxostat treatment group

No febuxostat treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Febuxostat treatment group

once daily after breakfast

Group Type: EXPERIMENTAL

Febuxostat

Intervention Type: DRUG

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.

Interventions

Febuxostat

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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yokohama City University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kiyoshi Hibi

associate professor of medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kiyoshi Hibi, MD

Role: STUDY_CHAIR

Yokohama City University Medical Center

Locations

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

Countries

Japan

Other Identifiers

D1407027

Identifier Type: -

Identifier Source: org_study_id