Efficacy and Safety Study of Binodenoson in Assessing Cardiac Ischemia

NCT ID: NCT00944970

Last Updated: 2012-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 578 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2006-12-31

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. 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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

binodenoson then adenosine

binodenoson (experimental); adenosine (active comparator)

Group Type: OTHER

binodenoson

Intervention Type: DRUG

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

adenosine

Intervention Type: DRUG

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

adenosine then binodenoson

adenosine (active comparator); binodenoson (experimental)

Group Type: OTHER

binodenoson

Intervention Type: DRUG

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

adenosine

Intervention Type: DRUG

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

adenosine then adenosine

Group Type: ACTIVE_COMPARATOR

adenosine

Intervention Type: DRUG

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

Interventions

binodenoson

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

Intervention Type: DRUG

adenosine

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

Intervention Type: DRUG

Other Intervention Names

CorVue

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert L. Rolleri, Pharm.D.

Role: STUDY_DIRECTOR

King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

Other Identifiers

MRE0470P-305

Identifier Type: -

Identifier Source: org_study_id