Study Stopped
Business decision to stop the program
A Study to Examine MPI SPECT Imaging With BMS068645 and Adenosine Compared to Coronary Angiography
A Phase 3, Parallel, Double Blind, Multicenter Trial to Examine Inducible Myocardial Perfusion Abnormality Detection With BMS068645 and Adenosine Stress SPECT Compared to Coronary Angiography
1 other identifier
interventional
2,000
1 country
77
Brief Summary
The purpose of the study is to determine whether BMS068645 is as effective as Adenosine SPECT at detecting blockages in heart arteries, and to determine if it will have fewer side effects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 13, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedFebruary 1, 2017
January 1, 2017
11 months
September 9, 2005
January 31, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity and specificity of BMS068645 vs. adenosine; to be determined at the end of the study after enrollment is complete
Secondary Outcomes (1)
Incidence of serious adverse events due to adenosine vs. BMS068645; incidence of adverse events due to adenosine vs. BMS068645; to be determined at the end of the study after enrollment, but with interim independent analysis by a safety monitoring board
Interventions
Eligibility Criteria
You may qualify if:
- Referral for pharmacologic stress SPECT MPI
- Have suspected Ischemic heart disease
You may not qualify if:
- Acute myocardial Infarction, Coronary artery bypass graft, percutaneous coronary intervention within 30 days of enrollment
- Severe asthma or COPD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (77)
Local Institution
Birmingham, Alabama, 35213, United States
Local Institution
Huntsville, Alabama, 35801, United States
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North Little Rock, Arkansas, 72117, United States
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Northridge, California, 91325, United States
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Rancho Mirage, California, 92270, United States
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Santa Clara, California, 95051, United States
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Santa Rosa, California, 95405, United States
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Walnut Creek, California, 94598, United States
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Bridgeport, Connecticut, 06606, United States
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Guilford, Connecticut, 06437, United States
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New Haven, Connecticut, 06510, United States
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Newark, Delaware, 19713, United States
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Fort Lauderdale, Florida, 33308, United States
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Gainesville, Florida, 32605, United States
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Gainesville, Florida, 32607, United States
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Gainesville, Florida, 32608, United States
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Jacksonville, Florida, 32207, United States
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Jacksonville, Florida, 32257, United States
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Jacksonville Beach, Florida, 32250, United States
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Jupiter, Florida, 33458, United States
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Miami, Florida, 33173, United States
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Safety Harbor, Florida, 34695, United States
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Stuart, Florida, 34996, United States
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Tamarac, Florida, 33321, United States
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Honolulu, Hawaii, 96817, United States
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Aurora, Illinois, 60504, United States
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Fox River Grove, Illinois, 60021, United States
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La Grange, Illinois, 60525, United States
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Peoria, Illinois, 61603, United States
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Winfield, Illinois, 60190, United States
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Fort Wayne, Indiana, 48604, United States
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Indianapolis, Indiana, 46260, United States
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Overland Park, Kansas, 66209, United States
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Louisville, Kentucky, 40205, United States
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Baton Rouge, Louisiana, 70808, United States
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Auburn, Maine, 04210, United States
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Scarborough, Maine, 04074, United States
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South Portland, Maine, 04106, United States
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Westminster, Maryland, 21157, United States
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Ayer, Massachusetts, 01432, United States
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Grand Rapids, Michigan, 49525, United States
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Minneapolis, Minnesota, 55415, United States
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Saint Cloud, Minnesota, 56303, United States
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Saint Louis Park, Minnesota, 55416, United States
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Tupelo, Mississippi, 38801, United States
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Kansas City, Missouri, 64111, United States
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Kansas City, Missouri, 64132, United States
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St Louis, Missouri, 63104, United States
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Albany, New York, 10025, United States
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New York, New York, 10029, United States
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West Islip, New York, 11795, United States
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Raleigh, North Carolina, 27609, United States
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Cincinnati, Ohio, 45219, United States
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Cleveland, Ohio, 44195, United States
Local Institution
Columbus, Ohio, 43210, United States
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Lorain, Ohio, 44053, United States
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Sandusky, Ohio, 44870, United States
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Westlake, Ohio, 44145, United States
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Tulsa, Oklahoma, 74104, United States
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Philadelphia, Pennsylvania, 19102, United States
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Wyomissing, Pennsylvania, 19610, United States
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Providence, Rhode Island, 02904, United States
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Simpsonville, South Carolina, 29681, United States
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Chattanooga, Tennessee, 37404, United States
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Johnson City, Tennessee, 37604, United States
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Nashville, Tennessee, 37203, United States
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Nashville, Tennessee, 37205, United States
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Oak Ridge, Tennessee, 37830, United States
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Amarillo, Texas, 79106, United States
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Houston, Texas, 77090, United States
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Plano, Texas, 75024, United States
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Hopewell, Virginia, 23860, United States
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Lynchburg, Virginia, 24501, United States
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Richmond, Virginia, 23230, United States
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Roanoke, Virginia, 24015, United States
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Spokane, Washington, 99204, United States
Local Institution
Wausau, Wisconsin, 54401, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mark Hibberd, MD, PhD
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 13, 2005
Study Start
April 1, 2005
Primary Completion
March 1, 2006
Last Updated
February 1, 2017
Record last verified: 2017-01