Efficacy and Safety Study of Binodenoson in Assessing Cardiac Ischemia

NCT00944970 | Completed Phase 3 DMC

• 1 other identifier: MRE0470P-305
• Study Type: interventional
• Target: 578
• Locations: 0 countries
• Sites: N/A

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

Keywords

Coronary artery disease; Angina; Anginal symptoms; Ischemic heart disease; Ischemia; Single photon emission computed tomography; Pharmacologic stress; Myocardial perfusion imaging; Suspected coronary artery disease; known coronary artery disease; typical or atypical anginal symptoms

Outcome Measures

Primary Outcomes (4)

• Summed difference in binodenoson and adenosine reader-generated Summed Difference Scores

  2 to 7 days apart

• Summed difference in adenosine- and adenosine-2 reader-generated Summed Difference Scores

  2 to 7 days apart

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

  2 to 7 days apart

• Extreme discrepancies in adenosine- and adenosine-2 reader-generated Summed Difference Scores

  2 to 7 days apart

Secondary Outcomes (33)

• Categorized reader-generated Summed Difference Scores (binodenoson and adenosine)

  2 to 7 days apart

• Categorized reader-generated Summed Difference Scores (adenosine-1 and adenosine-2)

  2 to 7 days apart

• Difference in reader-generated Summed Stress Scores (binodenoson and adenosine)

  2 to 7 days apart

• Difference in reader-generated Summed Stress Scores (adenosine-1 and adenosine-2)

  2 to 7 days apart

• Extreme discrepant reader-generated Summed Stress Scores (binodenoson and adenosine)

  2 to 7 days apart

Study Arms (3)

binodenoson then adenosine

OTHER

binodenoson (experimental); adenosine (active comparator)

Drug: binodenoson; Drug: adenosine

adenosine then binodenoson

OTHER

adenosine (active comparator); binodenoson (experimental)

Drug: binodenoson; Drug: adenosine

adenosine then adenosine

ACTIVE COMPARATOR

Drug: adenosine

Interventions

binodenoson DRUG

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

Also known as: CorVue

adenosine then binodenoson; binodenoson then adenosine

adenosine DRUG

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

adenosine then adenosine; adenosine then binodenoson; binodenoson then adenosine

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and sign an informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Myocardial Ischemia; Ischemia

Interventions

binodenoson; Adenosine

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Robert L. Rolleri, Pharm.D.

  King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2009
• First Posted: July 23, 2009
• Study Start: October 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: June 1, 2012

Record last verified: 2012-05