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

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ClinicalTrials.gov Identifier: NCT02279342
Recruitment Status : Terminated (Entry were insufficient as expected.)
First Posted : October 31, 2014
Last Update Posted : August 3, 2017
Sponsor:
Information provided by (Responsible Party):
Kiyoshi Hibi, Yokohama City University Medical Center

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Febuxostat Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: the Effect of Febuxostat on Coronary Plaque Volume in Patients With Chronic Stable Angina and Hyperuricemia
Study Start Date : October 2014
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina
Drug Information available for: Febuxostat

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.




Primary Outcome Measures :
  1. The percent changes in coronary plaque volume obtained by IVUS from baseline to follow up [ Time Frame: 8-12 months ]
  2. The percent changes in integrated backscatter signal obtained by integrated backscatter IVUS from baseline to follow up [ Time Frame: 8-12 ]

Secondary Outcome Measures :
  1. absolute changes of coronary plaque volume by IVUS from baseline to follow up [ Time Frame: 8-12 months ]
  2. absolute and percent changes in minimal lumen diameter and percent stenosis by QCA from baseline to follow up [ Time Frame: 8-12 months ]
  3. changes in plaque characteristics assessed by IVUS from baseline to follow up [ Time Frame: 8-12 months ]
  4. changes in serum uremic values and inflammatory markers from baseline to follow up [ Time Frame: 8-12 months ]
  5. prognosis(death, ACS, restenosis) [ Time Frame: 8-12 months ]
  6. nominal changes in plaque burden assessed by IVUS from baseline to follow up [ Time Frame: 8-12 months ]
  7. nominal changes in plaque burden adjusting for analyzed length assessed by IVUS from baseline to follow up [ Time Frame: 8-12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279342


Locations
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Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan, 232-0024
Sponsors and Collaborators
Yokohama City University Medical Center
Investigators
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Study Chair: Kiyoshi Hibi, MD Yokohama City University Medical Center

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Responsible Party: Kiyoshi Hibi, associate professor of medicine, Yokohama City University Medical Center
ClinicalTrials.gov Identifier: NCT02279342     History of Changes
Other Study ID Numbers: D1407027
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kiyoshi Hibi, Yokohama City University Medical Center:
Coronary artery disease
hyperuricemia
coronary plaque volume
IVUS

Additional relevant MeSH terms:
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Febuxostat
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina, Stable
Hyperuricemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Pathologic Processes
Gout Suppressants
Antirheumatic Agents