Coronary Artery DiseasePhase 4NCT01763996
The Influence of Febuxostat on Coronary Artery Endothelial Dysfunction in Participants With Chronic Stable Angina
A Phase 4 study testing Febuxostat in people with Coronary Artery Disease, run by Takeda at 1 site in United States.
Trial summary
The purpose of this study is to assess the effect of febuxostat on coronary artery flow in patients with coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Febuxostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Apr 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- Has a serum urate ≥4.0 mg/dL.
- Has a history of coronary artery disease, defined as:
- ≥50 % stenosis of ≥1 major coronary artery confirmed by angiography; OR
- Documented prior myocardial infarction (MI) by enzymes/electrocardiogram (ECG) changes; OR
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- Documented prior exercise or pharmacologic stress/echo myocardial imaging study positive for ischemia.
- Has estimated glomerular filtration rate (eGFR) ≥30 mL/min by Modification of Diet in Renal Disease (MDRD) at the screening visit.
- Has a change in coronary artery flow from rest to isometric handgrip exercise of less than + 10 mL/min.
- Is male or female and aged 18 to 85 years, inclusive.
- A female of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study.
- Is on stable (30 days prior to Screening Day-21) medication doses prescribed for any underlying medical condition (ie, hypertension, angina) and is expected to remain on stable doses throughout the study duration.
- Is able to take nitroglycerin for anginal symptoms during study procedures.
Who cannot join
- Has received any investigational compound within 30 days prior to Screening.
- Has received allopurinol or febuxostat in a previous clinical study or as a therapeutic agent with-in 6 months of randomization.
- Has gout or secondary hyperuricemia (eg, due to myeloproliferative disorder, or organ transplant) or has experienced a gout flare.
- Has a history of xanthinuria.
- Has known contraindication to magnetic resonance imaging (MRI) scanning
- Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
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- Has a history of hypersensitivity or allergies to febuxostat or nitroglycerin.
- Has hemoglobin <10 g/L at Screening.
- Has a history or clinical manifestations of a significant medical condition that might affect his/her ability to complete the study.
- Has any of the following during Screening:
- New York Heart Association Class III or IV heart failure.
- Acute coronary syndrome or a coronary revascularization procedure within 2 months of Screening.
- Wolff-Parkinson-White syndrome.
- Pacemaker or implantable cardioverter defibrillator.
- Arrhythmias (ie, supraventricular tachycardia (SVT), atrial fibrillation/flutter, or ventricular tachycardia (VT) during Screening).
- Has a recent history (within the last 2 months prior to Screening) of acute coronary syndrome or a coronary revascularization procedure, MI, heart failure, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
- Has a contraindication for using nitrates (severe anemia, increased intracranial pressure, and those with a known sensitivity or hypersensitivity to nitroglycerin or its ingredients, or other nitrates or nitrites; concomitant use either regularly and/or intermittently, with phosphodiesterase type 5 (PDE5) inhibitors).
- Has unstable angina that:
- Occurs when the patient is at rest.
- Is prolonged, usually greater than 20 minutes.
- Occurs with increasing in intensity, duration, and/or frequency.
- Responds poorly to nitroglycerin (ie, does not go away after three doses of nitroglycerin or returns after the nitroglycerin helped at first).
- Is unable to exercise sufficiently to complete exercise treadmill test (ETT) due to leg claudication, arthritis, deconditioning, or associated pulmonary disease.
- Has severe or critical valvular disease documented by echocardiogram, or congenital heart disease.
- The subject has left ventricular ejection fraction (LVEF) less than 35%, as documented by echocardiogram, left ventriculogram, or gated blood pool scan..
- The subject has clinically significant cardiac conduction defects (ie, second- or third-degree atrioventricular block, or sick sinus syndrome) at Screening
- Has hypertrophic cardiomyopathy.
- Has an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level of greater than 2.0 times the upper limit of normal, has active liver disease, or jaundice.
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 5 years prior to the Screening Visit.
- Is required or expected to require excluded medications including digoxin or digoxin-containing compounds.
- If female, is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
- Has participated in another clinical trial within the past 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Febuxostat on Coronary Artery Endothelial Dysfunction in Subjects With Chronic Stable Angina: A Phase 4 Randomized, Placebo-Controlled, Double-Blind, Cross-Over Study
The purpose of this study is to assess the effect of febuxostat on coronary artery flow in patients with coronary artery disease.
Read the detailed description
The drug being tested in this study is called febuxostat. Febuxostat is being tested to treat people who have angina. This study will look at the heart and blood flow of people who take febuxostat.
The study will enroll approximately 30 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups (or sequences)-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
- Sequence 1: 6 weeks febuxostat followed by 6 weeks of placebo.
- Sequence 2: 6 week placebo followed by 6 weeks of febuxostat
All participants will be asked to take one capsule at the same time each day throughout the study. All participants will be asked to record any time they have angina symptoms during the study.
This single-center trial will be conducted in the United States. The overall time to participate in this study is 16 weeks. Participants will make 7 visits to the clinic including a final visit 4 weeks after last dose of study drug for a follow-up assessment.
- Conditions
- Coronary Artery Disease
- Being tested
- Febuxostat, Febuxostat placebo
- Keywords
- Drug therapy
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FebuxostatDrug
Febuxostat capsules
Febuxostat placeboDrug
Febuxostat placebo-matching capsules
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: Febuxostat 80 mg + Placebo | Experimental | Febuxostat 80 mg, capsules, orally, once daily for 6 weeks in Period 1, followed by febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 2. Receives: Drug: Febuxostat; Drug: Febuxostat placebo |
| Sequence 2: Placebo + Febuxostat 80 mg | Experimental | Febuxostat placebo-matching capsules, orally, once daily for 6 weeks in Period 1, followed by febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 2. Receives: Drug: Febuxostat; Drug: Febuxostat placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Coronary Artery Flow From Rest to Isometric Handgrip (IHG) Exercise at the End of the Administration of Febuxostat and Placebo
Coronary artery flow was measured using magnetic resonance imaging (MRI) at rest and during sustained isometric (static) handgrip exercises. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.
Measured: Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)
Secondary outcomes (10)
Change in Coronary Artery Cross-Sectional Area From Rest to IHG Exercise at the End of the Administration of Febuxostat and Placebo
Coronary artery cross-sectional area was measured by MRI at rest and during sustained isometric (static) handgrip exercise. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.
Measured: Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)
Change in Coronary Flow Velocity From Rest to IHG Exercise at the End of the Administration of Febuxostat and Placebo
Coronary flow velocity was measured by MRI at rest and during sustained isometric (static) handgrip exercise. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.
Measured: Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)
Change in Coronary Artery Flow Following the Administration of Sublingual Nitroglycerin at the End of the Administration of Febuxostat and Placebo
Coronary artery flow was measured by MRI before and following administration of nitroglycerin under the tongue. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.
Measured: Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)
Change in Coronary Artery Cross Sectional Area Following the Administration of Sublingual Nitroglycerin at the End of the Administration of Febuxostat and Placebo
Coronary artery cross sectional area was measured by MRI before and following administration of nitroglycerin under the tongue. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.
Measured: Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)
Change in Coronary Flow Velocity Following the Administration of Sublingual Nitroglycerin at the End of the Administration of Febuxostat and Placebo
Coronary flow velocity was measured by MRI before and following administration of nitroglycerin under the tongue. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.
Measured: Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)
Change in Time to Onset of ≥1 mm ST-Segment Depression During Exercise Treadmill Test (ETT)
Time in seconds to ischemic ECG changes during ETT. Continuous electrocardiography (ECG) was performed during an exercise treadmill test (modified Bruce protocol) to assess the onset of ST-segment depression after administration of febuxostat or placebo for 6 weeks in participants with a normal ST segment at randomization. . Data at the end of each treatment period was combined for the febuxostat and the placebo arms.
Measured: Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)
Change in Maximum ST-segment Depression During Exercise Treadmill Test
Continuous ECG was performed during an exercise treadmill test (modified Bruce protocol) to assess the maximum ST-segment depression after 6 weeks of febuxostat or placebo treatment in participants with a normal ST segment at randomization. A negative change from Baseline indicates improvement. Data at the end of each treatment period was combined for the febuxostat and the placebo arms.
Measured: Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)
Percentage of Participants Stopping Exercise Treadmill Test Due to Angina at the End of the Administration of Febuxostat and Placebo
An exercise treadmill test (modified Bruce protocol) was performed. Data at the end of each treatment period was combined for the febuxostat and the placebo arms.
Measured: At the end of each 6 week treatment period (Week 6 and Week 12)
Time to Onset of Angina During Exercise Treadmill Test at the End of the Administration of Febuxostat and Placebo
Time in seconds to ischemic chest pain/ angina during ETT. Data at the end of each period was combined for the febuxostat and the placebo arms
Measured: At the end of each 6 week treatment period (Week 6 and Week 12)
Exercise Duration
Exercise duration is the exercise time in seconds during ETT. Data at the end of each period was combined for the febuxostat and the placebo arms.
Measured: At the end of each 6 week treatment period (Week 6 and Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startMay 2013
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763996
- Sponsor's protocol ID
- CCR-FEB-002
- Other IDs
- U1111-1136-2270
- Status last verified
- Mar 2016
- First submitted
- 7 Jan 2013
- Last updated
- 13 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hays AG, Iantorno M, Schar M, Lai S, Czarny M, Breton E, Palmer RN, Whelton A, Weiss RG, Gerstenblith G. The influence of febuxostat on coronary artery endothelial dysfunction in patients with coronary artery disease: A phase 4 randomized, placebo-controlled, double-blind, crossover trial. Am Heart J. 2018 Mar;197:85-93. doi: 10.1016/j.ahj.2017.11.006. Epub 2017 Nov 23.
PubMed 29447788
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Febuxostat on Coronary Artery Endothelial Dysfunction in Subjects With Chronic Stable Angina: A Phase 4 Randomized, Placebo-Controlled, Double-Blind, Cross-Over Study
- ClinicalTrials.gov ID
- NCT01763996
- Acronym / sponsor ID
- CCR-FEB-002
- Conditions
- Coronary Artery Disease
- Keywords
- Drug therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 9 Jan 2013 (estimated)
- Results
- Posted 13 Apr 2016
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 assess the effect of febuxostat on coronary artery flow in patients with coronary artery disease.
Detailed description
The drug being tested in this study is called febuxostat. Febuxostat is being tested to treat people who have angina. This study will look at the heart and blood flow of people who take febuxostat.
The study will enroll approximately 30 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups (or sequences)-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
- Sequence 1: 6 weeks febuxostat followed by 6 weeks of placebo.
- Sequence 2: 6 week placebo followed by 6 weeks of febuxostat
All participants will be asked to take one capsule at the same time each day throughout the study. All participants will be asked to record any time they have angina symptoms during the study.
This single-center trial will be conducted in the United States. The overall time to participate in this study is 16 weeks. Participants will make 7 visits to the clinic including a final visit 4 weeks after last dose of study drug for a follow-up assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: Febuxostat 80 mg + Placebo | Experimental | Drug: Febuxostat, Drug: Febuxostat placeboFebuxostat 80 mg, capsules, orally, once daily for 6 weeks in Period 1, followed by febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 2. |
| Sequence 2: Placebo + Febuxostat 80 mg | Experimental | Drug: Febuxostat, Drug: Febuxostat placeboFebuxostat placebo-matching capsules, orally, once daily for 6 weeks in Period 1, followed by febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 2. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- Has a serum urate ≥4.0 mg/dL.
- Has a history of coronary artery disease, defined as:
- Has estimated glomerular filtration rate (eGFR) ≥30 mL/min by Modification of Diet in Renal Disease (MDRD) at the screening visit.
Key exclusion criteria (32 listed)
- Has received any investigational compound within 30 days prior to Screening.
- Has received allopurinol or febuxostat in a previous clinical study or as a therapeutic agent with-in 6 months of randomization.
- Has gout or secondary hyperuricemia (eg, due to myeloproliferative disorder, or organ transplant) or has experienced a gout flare.
- Has a history of xanthinuria.
- Has known contraindication to magnetic resonance imaging (MRI) scanning
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 |
|---|---|---|
| FebuxostatFebuxostat capsules | Drug | Sequence 1: Febuxostat 80 mg + Placebo, Sequence 2: Placebo + Febuxostat 80 mg |
| Febuxostat placeboFebuxostat placebo-matching capsules | Drug | Sequence 1: Febuxostat 80 mg + Placebo, Sequence 2: Placebo + Febuxostat 80 mg |
Primary outcome
Change in Coronary Artery Flow From Rest to Isometric Handgrip (IHG) Exercise at the End of the Administration of Febuxostat and Placebo
Time frame: Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)
Coronary artery flow was measured using magnetic resonance imaging (MRI) at rest and during sustained isometric (static) handgrip exercises. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.
10 secondary outcomes
Change in Coronary Artery Cross-Sectional Area From Rest to IHG Exercise at the End of the Administration of Febuxostat and Placebo
Time frame: Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)
Change in Coronary Flow Velocity From Rest to IHG Exercise at the End of the Administration of Febuxostat and Placebo
Time frame: Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)
Change in Coronary Artery Flow Following the Administration of Sublingual Nitroglycerin at the End of the Administration of Febuxostat and Placebo
Time frame: Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)
Change in Coronary Artery Cross Sectional Area Following the Administration of Sublingual Nitroglycerin at the End of the Administration of Febuxostat and Placebo
Time frame: Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)
Change in Coronary Flow Velocity Following the Administration of Sublingual Nitroglycerin at the End of the Administration of Febuxostat and Placebo
Time frame: Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)
Change in Time to Onset of ≥1 mm ST-Segment Depression During Exercise Treadmill Test (ETT)
Time frame: Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)
Change in Maximum ST-segment Depression During Exercise Treadmill Test
Time frame: Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)
Percentage of Participants Stopping Exercise Treadmill Test Due to Angina at the End of the Administration of Febuxostat and Placebo
Time frame: At the end of each 6 week treatment period (Week 6 and Week 12)
Time to Onset of Angina During Exercise Treadmill Test at the End of the Administration of Febuxostat and Placebo
Time frame: At the end of each 6 week treatment period (Week 6 and Week 12)
Exercise Duration
Time frame: At the end of each 6 week treatment period (Week 6 and Week 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29447788Hays AG, Iantorno M, Schar M, Lai S, Czarny M, Breton E, Palmer RN, Whelton A, Weiss RG, Gerstenblith G. The influence of febuxostat on coronary artery endothelial dysfunction in patients with coronary artery disease: A phase 4 randomized, placebo-controlled, double-blind, crossover trial. Am Heart J. 2018 Mar;197:85-93. doi: 10.1016/j.ahj.2017.11.006. Epub 2017 Nov 23.
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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.
Medical Director study director
Takeda
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 Takeda at 1 site in United States.
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 13 inclusion and 32 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: finished, as of the sponsor's last update on 13 Apr 2016. 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 United States. 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?
Yes. Results are posted in the registry (first posted 13 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Coronary Artery Flow From Rest to Isometric Handgrip (IHG) Exercise at the End of the Administration of Febuxostat and Placebo (time frame: Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01763996, which also lists 1 linked publication.
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 13 Apr 2016.