The Influence of Febuxostat on Coronary Artery Endothelial Dysfunction in Participants With Chronic Stable Angina

Completed · Phase 4 · Has a placebo group

Conditions studied: Coronary Artery Disease

In brief

The purpose of this study is to assess the effect of febuxostat on coronary artery flow in patients with coronary artery disease.

Key facts

Study ID

NCT01763996

Run by

Takeda

People needed

30

Starts

2013-05-01

Expected to finish

2015-04-01

Last updated by the study team

2016-04-13

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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.

You may not qualify if…

• 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.
• 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..

Where it is running

• Study site — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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