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Efficacy and Safety Study of Binodenoson in Assessing Cardiac Ischemia (VISION-302)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00944294
Recruitment Status : Completed
First Posted : July 23, 2009
Last Update Posted : June 1, 2012
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE July 17, 2009
First Posted Date  ICMJE July 23, 2009
Last Update Posted Date June 1, 2012
Study Start Date  ICMJE February 2004
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2009)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00944294 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2009)
  • 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 [ Time Frame: 0 to 60 minutes after start of study drug administration ]
  • Patient-rated overall symptom bother [ Time Frame: 1 hour post-dosing ]
  • Patient preference for pharmacologic stress agent [ Time Frame: 1 to 4 days following 2nd procedure ]
  • Incidence of flushing [ Time Frame: 0 to 60 minutes after start of study drug administration ]
  • Patient-rated intensity of flushing [ Time Frame: 0 to 60 minutes after start of study drug administration ]
  • Incidence of chest pain [ Time Frame: 0 to 60 minutes after start of study drug administration ]
  • Patient-rated intensity of chest pain [ Time Frame: 0 to 60 minutes after start of study drug administration ]
  • Incidence of dyspnea [ Time Frame: 0 to 60 minutes after start of study drug administration ]
  • Patient-rated intensity of dyspnea [ Time Frame: 0 to 60 minutes after start of study drug administration ]
  • Incidence of nausea [ Time Frame: 0 to 60 minutes after start of study drug administration ]
  • Patient-rated intensity of nausea [ Time Frame: 0 to 60 minutes after start of study drug administration ]
  • Incidence of headache [ Time Frame: 0 to 60 minutes after start of study drug administration ]
  • Patient-rated intensity of headache [ Time Frame: 0 to 60 minutes after start of study drug administration ]
  • Incidence of abdominal discomfort [ Time Frame: 0 to 60 minutes after start of study drug administration ]
  • Patient-rated intensity of abdominal discomfort [ Time Frame: 0 to 60 minutes after start of study drug administration ]
  • Incidence of dizziness [ Time Frame: 0 to 60 minutes after start of study drug administration ]
  • Patient-rated intensity of dizziness [ Time Frame: 0 to 60 minutes after start of study drug administration ]
  • Overall incidence of adverse events [ Time Frame: up to 7 days post-dosing ]
  • Peak change in heart rate [ Time Frame: 0 to 60 minutes after start of study drug administration ]
  • Peak change in systolic blood pressure [ Time Frame: 0 to 60 minutes after start of study drug administration ]
  • Peak change in diastolic blood pressure [ Time Frame: 0 to 60 minutes after start of study drug administration ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Binodenoson in Assessing Cardiac Ischemia
Official Title  ICMJE Vasodilator Induced Stress In CONcordance With Adenosine (VISION-302)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Drug: binodenoson
    30-second intravenous injection (bolus) of binodenoson (1.5 mcg/kg) and a 6-minute intravenous infusion of placebo
    Other Name: CorVue
  • Drug: adenosine
    30-second intravenous injection (bolus) of placebo and a 6-minute intravenous infusion of adenosine (140 mcg/kg/minute)
Study Arms  ICMJE
  • binodenoson then adenosine
    binodenoson (experimental); adenosine (active comparator)
    Interventions:
    • Drug: binodenoson
    • Drug: adenosine
  • adenosine then binodenoson
    adenosine (active comparator); binodenoson (experimental)
    Interventions:
    • Drug: binodenoson
    • Drug: adenosine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2009)
419
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2006
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00944294
Other Study ID Numbers  ICMJE MRE0470P-302
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kenneth Sommerville, M.D., Vice President, Clinical Development
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Robert L. Rolleri, Pharm.D. King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
PRS Account Pfizer
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP