Coronary Artery DiseasePhase 4NCT02279342
the Effect of Febuxostat on Coronary Plaque Volume in Patients With Chronic Stable Angina and Hyperuricemia
A Phase 4 study testing Febuxostat in people with Coronary Artery Disease, run by Yokohama City University Medical Center at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Febuxostat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2014to 31 Mar 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 20 years of age or older at enrollment who are able to visit
- Patients with chronic stable angina who have severe coronary stenosis wich require PCI.
- Patients who have at least one coronary plaque (≧ 500μm in thickness or % plaque of 20% or more) at the non-culprit vessels.
- Patients with hyperuricemia, who have a serum uric acid level >7.0mg/dL within 2 months prior to enrollement.
- Patients who personally given written informed consent to participate in this study.
Who cannot join
- Patients who had undergone previous PCI for the lesion under investigation.
- Patients with gouty tophus, or patients with subjective symptoms of gouty arthritis within 1 year prior to enrollment.
- Patients with a previous history of hypersensitivity to febuxostat or allopurinol.
- Patients with serious kidney disease, Acute kidney disease, nephrotic syndrome, dialysis patients, kidney transplant patients, eGFR < 30 mL/min/1.73m2, etc.
- Patients with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 2 or more times the upper limit of normal.
- Patients on any of the following medications at enrollment Mercaptopurine hydrate, azathioprine, vidarabine, or didanosine.
- 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.
- Patients otherwise judged by the principal or sub-investigator to be unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024
About this study
The purpose of this study is to investigate the effects of febuxostat on coronary plaque volume in patients with chronic stable angina and hyperuricemia.
Read the 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
- Being tested
- Febuxostat
- Keywords
- Coronary artery disease, hyperuricemia, coronary plaque volume, IVUS
- Medical subject headings
- Coronary Artery Disease, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FebuxostatDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Non febuxostat treatment group | No intervention | No febuxostat treatment |
| Febuxostat treatment group | Experimental | once daily after breakfast Receives: Drug: Febuxostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent changes in coronary plaque volume obtained by IVUS from baseline to follow up
Measured: 8-12 months
The percent changes in integrated backscatter signal obtained by integrated backscatter IVUS from baseline to follow up
Measured: 8-12
Secondary outcomes (7)
absolute changes of coronary plaque volume by IVUS from baseline to follow up
Measured: 8-12 months
absolute and percent changes in minimal lumen diameter and percent stenosis by QCA from baseline to follow up
Measured: 8-12 months
changes in plaque characteristics assessed by IVUS from baseline to follow up
Measured: 8-12 months
changes in serum uremic values and inflammatory markers from baseline to follow up
Measured: 8-12 months
prognosis(death, ACS, restenosis)
Measured: 8-12 months
nominal changes in plaque burden assessed by IVUS from baseline to follow up
Measured: 8-12 months
nominal changes in plaque burden adjusting for analyzed length assessed by IVUS from baseline to follow up
Measured: 8-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startOct 2014
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Why it stopped: Entry were insufficient as expected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yokohama City University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kiyoshi Hibi, Yokohama City University Medical Center
- Investigators
- Kiyoshi Hibi, MD, Study chair, Yokohama City University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279342
- Sponsor's protocol ID
- D1407027
- Status last verified
- Aug 2017
- First submitted
- 14 Aug 2014
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Febuxostat on Coronary Plaque Volume in Patients With Chronic Stable Angina and Hyperuricemia
- ClinicalTrials.gov ID
- NCT02279342
- Acronym / sponsor ID
- D1407027
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, hyperuricemia, coronary plaque volume, IVUS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Entry were insufficient as expected.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Yokohama City University Medical CenterUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non febuxostat treatment group | No intervention | –No febuxostat treatment |
| Febuxostat treatment group | Experimental | Drug: Febuxostatonce daily after breakfast |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients 20 years of age or older at enrollment who are able to visit
- Patients with chronic stable angina who have severe coronary stenosis wich require PCI.
- Patients who have at least one coronary plaque (≧ 500μm in thickness or % plaque of 20% or more) at the non-culprit vessels.
- Patients with hyperuricemia, who have a serum uric acid level >7.0mg/dL within 2 months prior to enrollement.
- Patients who personally given written informed consent to participate in this study.
Key exclusion criteria (8 listed)
- Patients who had undergone previous PCI for the lesion under investigation.
- Patients with gouty tophus, or patients with subjective symptoms of gouty arthritis within 1 year prior to enrollment.
- Patients with a previous history of hypersensitivity to febuxostat or allopurinol.
- Patients with serious kidney disease, Acute kidney disease, nephrotic syndrome, dialysis patients, kidney transplant patients, eGFR < 30 mL/min/1.73m2, etc.
- Patients with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 2 or more times the upper limit of normal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FebuxostatThe 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. | Drug | Febuxostat treatment group |
Primary outcome
The percent changes in coronary plaque volume obtained by IVUS from baseline to follow up
Time frame: 8-12 months
The percent changes in integrated backscatter signal obtained by integrated backscatter IVUS from baseline to follow up
Time frame: 8-12
7 secondary outcomes
absolute changes of coronary plaque volume by IVUS from baseline to follow up
Time frame: 8-12 months
absolute and percent changes in minimal lumen diameter and percent stenosis by QCA from baseline to follow up
Time frame: 8-12 months
changes in plaque characteristics assessed by IVUS from baseline to follow up
Time frame: 8-12 months
changes in serum uremic values and inflammatory markers from baseline to follow up
Time frame: 8-12 months
prognosis(death, ACS, restenosis)
Time frame: 8-12 months
nominal changes in plaque burden assessed by IVUS from baseline to follow up
Time frame: 8-12 months
nominal changes in plaque burden adjusting for analyzed length assessed by IVUS from baseline to follow up
Time frame: 8-12 months
Results and safety
The study was stopped early (reason given: Entry were insufficient as expected.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kiyoshi Hibi, MD study chair
Yokohama City University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Febuxostat in people with Coronary Artery Disease, run by Yokohama City University Medical Center at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Entry were insufficient as expected.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percent changes in coronary plaque volume obtained by IVUS from baseline to follow up (time frame: 8-12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2017.