A Study to Examine MPI SPECT Imaging With BMS068645 and Adenosine Compared to Coronary Angiography

Condition(s) targeted: Heart Disease; Ischemic Heart Disease

Intervention: apadenoson (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Lantheus Medical Imaging

Official(s) and/or principal investigator(s):
Mark Hibberd, MD, PhD, Study Director, Affiliation: Bristol-Myers Squibb

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

Official title: 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

Study design: Diagnostic, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Sensitivity and specificity of BMS068645 vs. adenosine; to be determined at the end of the study after enrollment is complete

Secondary outcome: 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Referral for pharmacologic stress SPECT MPI

- Have suspected Ischemic heart disease

Exclusion Criteria:

- Acute myocardial Infarction, Coronary artery bypass graft, percutaneous coronary

intervention within 30 days of enrollment

- Severe asthma or COPD

Local Institution, Huntsville, Alabama 35801, United States

Local Institution, Birmingham, Alabama 35213, United States

Local Institution, North Little Rock, Arkansas 72117, United States

Local Institution, Rancho Mirage, California 92270, United States

Local Institution, Walnut Creek, California 94598, United States

Local Institution, Santa Rosa, California 95405, United States

Local Institution, Northridge, California 91325, United States

Local Institution, Santa Clara, California 95051, United States

Local Institution, New Haven, Connecticut 06510, United States

Local Institution, Guilford, Connecticut 06437, United States

Local Institution, Bridgeport, Connecticut 06606, United States

Local Institution, Newark, Delaware 19713, United States

Local Institution, Miami, Florida 33173, United States

Local Institution, Tamarac, Florida 33321, United States

Local Institution, Gainesville, Florida 32605, United States

Local Institution, Jupiter, Florida 33458, United States

Local Institution, Jacksonville, Florida 32207, United States

Local Institution, Stuart, Florida 34996, United States

Local Institution, Jacksonville, Florida 32257, United States

Local Institution, Gainesville, Florida 32608, United States

Local Institution, Jacksonville Beach, Florida 32250, United States

Local Institution, Gainesville, Florida 32607, United States

Local Institution, Fort Lauderdale, Florida 33308, United States

Local Institution, Safety Harbor, Florida 34695, United States

Local Institution, Honolulu, Hawaii 96817, United States

Local Institution, Winfield, Illinois 60190, United States

Local Institution, Peoria, Illinois 61603, United States

Local Institution, Aurora, Illinois 60504, United States

Local Institution, Fox River Grove, Illinois 60021, United States

Local Institution, La Grange, Illinois 60525, United States

Local Institution, Indianapolis, Indiana 46260, United States

Local Institution, Fort Wayne, Indiana 48604, United States

Local Institution, Overland Park, Kansas 66209, United States

Local Institution, Louisville, Kentucky 40205, United States

Local Institution, Baton Rouge, Louisiana 70808, United States

Local Institution, Scarborough, Maine 04074, United States

Local Institution, South Portland, Maine 04106, United States

Local Institution, Auburn, Maine 04210, United States

Local Institution, Westminster, Maryland 21157, United States

Local Institution, Ayer, Massachusetts 01432, United States

Local Institution, Grand Rapids, Michigan 49525, United States

Local Institution, St. Louis Park, Minnesota 55416, United States

Local Institution, Minneapolis, Minnesota 55415, United States

Local Institution, St. Cloud, Minnesota 56303, United States

Local Institution, Tupelo, Mississippi 38801, United States

Local Institution, St. Louis, Missouri 63104, United States

Local Institution, Kansas City, Missouri 64111, United States

Local Institution, Kansas City, Missouri 64132, United States

Local Institution, West Islip, New York 11795, United States

Local Institution, Albany, New York 10025, United States

Local Institution, New York, New York 10029, United States

Local Institution, Raleigh, North Carolina 27609, United States

Local Institution, Columbus, Ohio 43210, United States

Local Institution, Lorain, Ohio 44053, United States

Local Institution, Westlake, Ohio 44145, United States

Local Institution, Sandusky, Ohio 44870, United States

Local Institution, Cincinnati, Ohio 45219, United States

Local Institution, Cleveland, Ohio 44195, United States

Local Institution, Tulsa, Oklahoma 74104, United States

Local Institution, Wyomissing, Pennsylvania 19610, United States

Local Institution, Philadelphia, Pennsylvania 19102, United States

Local Institution, Providence, Rhode Island 02904, United States

Local Institution, Simpsonville, South Carolina 29681, United States

Local Institution, Nashville, Tennessee 37203, United States

Local Institution, Chattanooga, Tennessee 37404, United States

Local Institution, Nashville, Tennessee 37205, United States

Local Institution, Oak Ridge, Tennessee 37830, United States

Local Institution, Johnson City, Tennessee 37604, United States

Local Institution, Houston, Texas 77090, United States

Local Institution, Plano, Texas 75024, United States

Local Institution, Amarillo, Texas 79106, United States

Local Institution, Hopewell, Virginia 23860, United States

Local Institution, Richmond, Virginia 23230, United States

Local Institution, Roanoke, Virginia 24015, United States

Local Institution, Lynchburg, Virginia 24501, United States

Local Institution, Spokane, Washington 99204, United States

Local Institution, Wausau, Wisconsin 54401, United States

Starting date: April 2005
Last updated: April 8, 2008