Efficacy and Safety Study of Binodenoson in Assessing Cardiac Ischemia

Pfizer419 enrolled

Overview

Binodenoson (an experimental drug) and adenosine (an FDA-approved drug that is currently used by doctors) are used to increase blood flow to the heart just like when a person exercises on a treadmill. Using imaging techniques, this increased blood flow can help determine if areas of the heart are not getting enough blood and oxygen during exercise. The purpose of the study is to determine if binodenoson is as good as adenosine in determining if there are areas of the heart not getting enough oxygen when blood flow to the heart is increased.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Enrollment

419

Conditions

Coronary Artery Disease

Interventions

binodenosonDRUG

30-second intravenous injection (bolus) of binodenoson (1.5 mcg/kg) and a 6-minute intravenous infusion of placebo

adenosineDRUG

30-second intravenous injection (bolus) of placebo and a 6-minute intravenous infusion of adenosine (140 mcg/kg/minute)

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Able to understand and sign an informed consent form. Exclusion Criteria: * Women who are of childbearing potential. * Very low likelihood of coronary artery disease (by American Heart Association and American College of Cardiology standards). * Documented history of acute myocardial infarction within 30 days. * Percutaneous coronary intervention or coronary bypass graft surgery within 3 years, unless typical or atypical anginal symptoms are present. * Reactive airway disease or other contraindication that preclude a patient from receiving adenosine. * Previous heart transplant or listed to receive a heart transplant. * Cardiomyopathy (idiopathic dilated, restrictive, hypertrophic). * History of hemodynamically significant supraventricular tachycardia or sustained ventricular tachycardia. * Presence of second- or third-degree AV block (in the absence of permanent pacemaker). * Left ventricular ejection fraction greater than 35%, known prior to the first imaging procedure. * Presence of advanced heart failure, New York Heart Association Class IV. * History of vasospastic/Prinzmetal angina. * Active (under treatment) cancer (except skin cancers). * Inability to discontinue antianginal medications, Aggrenox®, dipyridamole, and xanthine-containing drugs and foods (including caffeine) as required prior to each imaging procedure. * Previous participation in a study of binodenoson. * Any physical or psychosocial condition that, based on the Investigator's judgment, would prevent the patient from completing the study.

Outcomes

Primary Outcomes

Difference in binodenoson and adenosine reader-generated Summed Difference Scores

Time frame: 2 to 7 days apart

Extreme discrepancies in binodenoson and adenosine reader-generated Summed Difference Scores

Time frame: 2 to 7 days apart

Secondary Outcomes

Categorized reader-generated Summed Difference Scores

Time frame: 2 to 7 days apart

Difference in reader-generated Summed Stress Scores

Time frame: 2 to 7 days apart

Extreme discrepant reader-generated Summed Stress Scores

Time frame: 2 to 7 days apart

Categorized reader-generated Summed Stress Scores

Time frame: 2 to 7 days apart

Sensitivity compared to coronary angiography

Time frame: angiography obtained up to 60 days post-image

Specificity compared to coronary angiography

Time frame: angiography obtained up to 60 days post-image

Sensitivity compared to clinical endpoint

Time frame: clinical endpoint obtained up to 60 days post-image

Specificity compared to clinical endpoint

Time frame: clinical endpoint obtained up to 60 days post-image

Incidence of second- or third-degree AV block

Data from ClinicalTrials.gov

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