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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02279342
• Other study ID #: D1407027
• Status: Terminated
• Phase: Phase 4
• First received: August 14, 2014
• Last updated: August 2, 2017
• Start date: October 2014
• Est. completion date: March 31, 2017

Study information

• Verified date: August 2017
• Source: Yokohama City University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Angina, Stable
• Coronary Artery Disease
• Coronary Disease
• Hyperuricemia
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Japan	Yokohama City University Medical Center	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Yokohama City University Medical Center

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percent changes in coronary plaque volume obtained by IVUS from baseline to follow up		8-12 months
Primary	The percent changes in integrated backscatter signal obtained by integrated backscatter IVUS from baseline to follow up		8-12
Secondary	absolute changes of coronary plaque volume by IVUS from baseline to follow up		8-12 months
Secondary	absolute and percent changes in minimal lumen diameter and percent stenosis by QCA from baseline to follow up		8-12 months
Secondary	changes in plaque characteristics assessed by IVUS from baseline to follow up		8-12 months
Secondary	changes in serum uremic values and inflammatory markers from baseline to follow up		8-12 months
Secondary	prognosis(death, ACS, restenosis)		8-12 months
Secondary	nominal changes in plaque burden assessed by IVUS from baseline to follow up		8-12 months
Secondary	nominal changes in plaque burden adjusting for analyzed length assessed by IVUS from baseline to follow up		8-12 months