Study the Effects of Ranolazine on Myocardial Perfusion Assessed by Serial Quantitative Exercise SPECT Imaging



Status:Completed
Conditions:Angina, Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:11/11/2012
Start Date:September 2010
End Date:October 2012
Contact:Jennifer Meriwether
Email:jennifer.meriwether@gilead.com
Phone:1-650-524-3890

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A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Cross-over Trial to Evaluate the Effects of Ranolazine on Myocardial Perfusion Assessed by Serial Quantitative Exercise SPECT Imaging


The purpose of this study is to evaluate if ranolazine can improve blood flow to your heart
(myocardial perfusion) by SPECT MPI when taken prior to exercise.


To evaluate the effect of ranolazine 1000 mg administered twice daily compared to placebo on
exercise-induced myocardial perfusion defect size (PDS) and total perfusion deficit (TPD),
assessed by gated single photon emission computed tomography (SPECT) myocardial perfusion
imaging (MPI) in subjects with documented exercise induced myocardial ischemia at baseline.

Key Inclusion Criteria:

- Exercise SPECT MPI study (stress and rest) showing at least 10% reversible myocardial
ischemia (as confirmed by the core nuclear laboratory) performed not more than 12
weeks prior to Screening, OR

- Exercise SPECT MPI study (stress and rest) conducted during screening (after
consultation with the Medical Monitor and after informed consent has been obtained)
showing at least 10% reversible myocardial ischemia (as confirmed by the core nuclear
laboratory)

- Stable antianginal medical therapy (excluding short-acting nitroglycerin)

Key Exclusion Criteria:

- Left bundle branch block

- Automated implantable defibrillator and/or pacemaker (selected subjects with
permanent pacemakers who have an intact sinus mechanism may be included following
consultation with the Medical Monitor)

- Intervening coronary revascularization between the time of qualifying exercise SPECT
MPI study and Randomization

- Acute myocardial infarction within 60 days prior to Screening or at any time after
the qualifying exercise SPECT MPI study, or MI undergoing staged intervention during
a subject's participation in the trial

- Unstable angina within 30 days prior to Screening, or at any time after the
qualifying exercise SPECT MPI study

- Coronary artery bypass graft (CABG) surgery within 60 days prior to Screening or at
any time after the qualifying exercise SPECT MPI study, or percutaneous coronary
intervention (PCI) within 30 days prior to Screening or at any time after the
qualifying exercise SPECT MPI study

- Anticipated coronary revascularization during the trial period

- Cerebrovascular Attack (CVA) or Transient Ischemic Attack (TIA) within 90 days prior
to Screening

- History of serious arrhythmias

- Currently in atrial fibrillation or atrial flutter

- QTc interval > 500 milliseconds

- Diagnosed as having New York Heart Association (NYHA) Class III or IV heart failure

- Inability to exercise or exercise limitation due to other co morbidities that may
interfere with ability to perform required exercise SPECT MPI study

- Body Mass Index (BMI) greater than or equal to 38 kg/m2 (may be up to 40 kg/m2 after
consultation with the Medical Monitor)

- Any absolute contraindications to exercise stress testing
We found this trial at
38
sites
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Beverly Hills, CA
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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400 Gresham Dr
Norfolk, Virginia 23507
757-627-7446
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St. Petersburg, Florida 33706
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Albany, New York 12212
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Bay City, Michigan 48706
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Boynton Beach, Florida 33437
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Camp Hill, Pennsylvania 17011
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Hartford, Connecticut 06102
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Houston, Texas 77002
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Imperial, California 92251
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Jackson, Tennessee 38305
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Jacksonville, Florida 32216
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Jacksonville, Florida 32216
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Kansas City, Missouri 64111
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Lincoln, California 95648
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Massapequa, New York 11758
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Mission Viejo, California 92691
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Nashville, Tennessee 37208
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Newark, Delaware 19713
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Orlando, Florida 32806
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Owensboro, Kentucky 42303
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Salinas, California 93901
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Salisbury, Maryland 21804
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San Antonio, Texas 78229
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Slidell, Louisiana 70458
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