Status:
COMPLETED
Efficacy and Safety Study of Binodenoson in Assessing Cardiac Ischemia
Lead Sponsor:
Pfizer
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief Summary
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....
Eligibility Criteria
Inclusion
- Able to understand and sign an informed consent form.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
419 Patients enrolled
Trial Details
Trial ID
NCT00944294
Start Date
February 1 2004
End Date
April 1 2006
Last Update
June 1 2012
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