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

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

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Febuxostat

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 232-0024
      • Yokohama City University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Non febuxostat treatment group; No febuxostat treatment
Experimental: Febuxostat treatment group; once daily after breakfast	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The percent changes in coronary plaque volume obtained by IVUS from baseline to follow up	8-12 months
The percent changes in integrated backscatter signal obtained by integrated backscatter IVUS from baseline to follow up	8-12

Secondary Outcome Measures

Outcome Measure	Time Frame
absolute changes of coronary plaque volume by IVUS from baseline to follow up	8-12 months
absolute and percent changes in minimal lumen diameter and percent stenosis by QCA from baseline to follow up	8-12 months
changes in plaque characteristics assessed by IVUS from baseline to follow up	8-12 months
changes in serum uremic values and inflammatory markers from baseline to follow up	8-12 months
prognosis(death, ACS, restenosis)	8-12 months
nominal changes in plaque burden assessed by IVUS from baseline to follow up	8-12 months
nominal changes in plaque burden adjusting for analyzed length assessed by IVUS from baseline to follow up	8-12 months

Collaborators and Investigators

• Sponsor: Yokohama City University Medical Center
• Investigators: Study Chair: Kiyoshi Hibi, MD, Yokohama City University Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): March 31, 2017
• Study Completion (Actual): March 31, 2017

Study Registration Dates

• First Submitted: August 14, 2014
• First Submitted That Met QC Criteria: October 30, 2014
• First Posted (Estimate): October 31, 2014

Study Record Updates

• Last Update Posted (Actual): August 3, 2017
• Last Update Submitted That Met QC Criteria: August 2, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Coronary artery disease; IVUS; hyperuricemia; coronary plaque volume
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Angina, Stable; Hyperuricemia; Antirheumatic Agents; Gout Suppressants; Febuxostat
• Other Study ID Numbers: D1407027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No