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.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Key Inclusion Criteria:
- Written informed consent prior to any study procedures
- Clinically indicated exercise SPECT MPI (stress and rest scans) performed within 4
weeks prior to screening
- At least 10% reversible myocardial ischemia on clinically indicated exercise SPECT
MPI study as confirmed by the core nuclear laboratory
- Stable doses of ≤ 2 antianginal medications (not including short-acting
nitroglycerin)
- Females of childbearing potential must agree to utilize highly effective
contraception methods from screening throughout the duration of study treatment and
for 14 days following the last dose of study drug
- Able to perform exercise stress testing
Key Exclusion Criteria:
- Left bundle branch block
- Implantable cardiac defibrillator
- Pacemaker
- Intervening coronary revascularization between the time of their prior clinically
indicated exercise SPECT MPI study and Screening
- Acute myocardial infarction within 60 days prior to screening, or MI with planned
intervention during the duration of this study
- Unstable angina within 30 days prior to Screening
- Coronary artery bypass graft (CABG) surgery within 60 days prior to Screening or
percutaneous coronary intervention (PCI) within 30 days prior to Screening
- Anticipated coronary revascularization during the study period
- Cerebrovascular Attack (CVA) or Transient Ischemic Attack (TIA) within 90 days prior
to Screening
- Resting LVEF < 35%
- 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 exercise SPECT MPI study
- Body Mass Index (BMI) ≥ 38 kg/m2
- Any absolute contraindications to exercise stress testing
- Females who are pregnant, or breast-feeding
Jennifer Meriwether, Phone: 1-650-524-3890, Email: jennifer.meriwether@gilead.com
University of Alabama at Birmingham, Birmingham, Alabama 35294, United States; Recruiting
Misty Pruitt, Phone: 205-996-2311
Jack Heo, MD, Principal Investigator
Cardiovascular Research Foundation of Southern California, Beverly Hills, California 90210, United States; Recruiting
Judy Mao, Phone: 310-275-9551
Ronald Karlsberg, MD, Principal Investigator
Clinical Trials Research, Lincoln, California 95648, United States; Recruiting
Leesa Koskela, Phone: 916-781-6718
Jeffrey Wayne, MD, Principal Investigator
Mission Internal Medical Group, Mission Viejo, California 92691, United States; Recruiting
Rhodora Neu, CRC, Phone: 949-364-3388
Gregory S Thomas, MD, Principal Investigator
Hartford Hospital, Hartford, Connecticut 06102, United States; Recruiting
Deborah Katten, RN, Phone: 860-545-1537
Gary Heller, MD, Principal Investigator
Alfieri Cardiology, Newark, Delaware 19713, United States; Recruiting
Colleen Buchanan, Phone: 302-731-0001
Paul Alfieri, MD, Principal Investigator
Zasa Clinical Research, Boyton Beach, Florida 33472, United States; Recruiting
Susan Edwards, Phone: 561-964-7880
Debra Weinstein, MD, Principal Investigator
Jacksonville Cardiovascular Center, Jacksonville, Florida 32216, United States; Recruiting
Jewell Baker, Phone: 904-493-6555
Waddah Salman, MD, Principal Investigator
St. Luke's Cardiology Associates, Jacksonville, Florida 32216, United States; Recruiting
Melody Thompson, Phone: 904-296-0278, Ext: 236
Julius Dean, MD, Principal Investigator
Cardiovascular Research Center of South Florida, Miami, Florida 33173, United States; Recruiting
Ruben Dominguez, Phone: 305-275-8808
Karl Lembcke, MD, Principal Investigator
The Heart and Vascular Institute of Florida, St. Petersburg, Florida 33709, United States; Recruiting
Heather Harteneck, Phone: 727-490-2117
Peter Wassmer, MD, Principal Investigator
Cardiology Partners Clinical Research Institute, Wellington, Florida 33449, United States; Recruiting
Blake Liebeskind, Phone: 561-676-8913
Eliezer Hernandez, MD, Principal Investigator
Fox Valley Clinical Research Center, LLC, Aurora, Illinois 60504, United States; Recruiting
Bonnie Resch, Phone: 630-723-3485
Santosh Gill, MD, Principal Investigator
Cardiovascular Research of Northwest Indiana, LLC, Munster, Indiana 46321, United States; Recruiting
Ricardo Guedes, Phone: 219-934-4200
Wail Asfour, MD, Principal Investigator
Research Integrity, LLC, Owensboro, Kentucky 42303, United States; Recruiting
Julie Baker, Phone: 270-691-1827
Kisher Vora, MD, Principal Investigator
Louisiana Heart Center, Covington, Louisiana 70403, United States; Recruiting
Tasha Stevenson, Phone: 985-871-4155, Ext: 308
Marc Bernstein, MD, Principal Investigator
Louisiana Heart Center, Hammond, Louisiana 70403, United States; Recruiting
Tasha Stevenson, Phone: 985-370-7739, Ext: 113
Frank Arena, MD, Principal Investigator
Louisiana Heart Center, LaPlace, Louisiana 70068, United States; Withdrawn
Louisiana Heart Center, Slidell, Louisiana 70458, United States; Recruiting
Daphne Dureau, Phone: 985-649-2700, Ext: 213
Bruce Iteld, MD, Principal Investigator
Androscroggin Cardiology Associates DBA Maine Research Associates, Auburn, Maine 04210, United States; Recruiting
Jessica Gamache, Phone: 207-783-2795
Robert Weiss, MD, Principal Investigator
Delmarva Heart Research Foundation, Inc, Salisbury, Maryland 21804, United States; Recruiting
Kathryn Fiddler, Phone: 410-334-2333
M. Greg Treuth, MD, Principal Investigator
Great Lakes Research Group, Bay City, Michigan 48706, United States; Recruiting
Terri Vittitow, Phone: 989-895-9100
Jeffrey Potts, MD, Principal Investigator
Cardiovascular Imaging Technologies, Kansas City, Missouri 64111, United States; Recruiting
Staci Courter, Phone: 816-531-2842, Ext: 107
Timothy Bateman, MD, Principal Investigator
Albany Associates in Cardiology, Albany, New York 12205, United States; Withdrawn
Dr. Michael Sacher, Massapequa, New York 11758, United States; Recruiting
Regina Massaro, Phone: 516-882-9600
Michael Sacher, MD, Principal Investigator
Columbia University Medical Center, New York, New York 10032, United States; Recruiting
Magnolia Jimenez, Phone: 210-305-4275
Sabahat Bokhari, MD, Principal Investigator
Duke University Medical Center, Durham, North Carolina 27710, United States; Recruiting
Melissa Jenkins, Phone: 919-684-7752
Salvador Borges-Neto, MD, Principal Investigator
University of Cincinnati, Cincinnati, Ohio 45267, United States; Recruiting
Amy Friesen, Phone: 513-558-5145
Myron Gerson, MD, Principal Investigator
University of Ottawa Heart Institute, Ottawa, Ontario K1Y 4W7, Canada; Recruiting
Marlie Poirier, Phone: 613-761-5103
Terrence Ruddy, MD, Principal Investigator
Heritage Cardiology, Camp Hill, Pennsylvania 17011, United States; Recruiting
Kimberly Darrow, Phone: 717-441-1725
Venkatesh Nadar, MD, Principal Investigator
University of Pittsburgh Medical Center Cardiovascular Institute, Pittsburgh, Pennsylvania 15213, United States; Recruiting
Louise Martin, Phone: 412-647-3435
Prem Soman, MD, Principal Investigator
ECOGENE-21 Clinical Trial Center, Chicoutimi Hospital, Chicoutimi, Quebec G7H 7P2, Canada; Recruiting
Sophie Rousseau, Phone: 418-541-1024
Gerald Tremblay, MD, Principal Investigator
Chum Hotel Dieu, Montreal, Quebec H2W 1T8, Canada; Recruiting
Renee Duclos, Phone: 514-890-8000, Ext: 14803
Carol Lemay, Phone: 514-890-8000, Ext: 14803
Samer Mansour, MD, Principal Investigator
Montreal Heart Institute, Montreal, Quebec H1T 1C8, Canada; Recruiting
Nathalie Nadeau, Phone: 1-514-376-3330, Ext: 3214
Jean Gregoire, MD, Principal Investigator
Kore Cardiovascular Research, Jackson, Tennessee 38305, United States; Recruiting
Donna Manns, Phone: 731-512-0104
Elie Hage-Korban, MD, Principal Investigator
Meharry Medical College, Nashville, Tennessee 37208, United States; Recruiting
Denise Clarke, Phone: 615-327-6884
John Murray, MD, Principal Investigator
Cardiovascular Associates of East Texas, P.A., Tyler, Texas 75701, United States; Recruiting
James Crump, Phone: 905-595-2283
Scott Wright, MD, Principal Investigator
University of Virginia Health System, Charlottesville, Virginia 22908, United States; Recruiting
Jayne Missel, Phone: 434-243-7195
Jamieson Bourque, MD, Principal Investigator
Clinical Research Associates of Tidewater, Norfolk, Virginia 23507, United States; Withdrawn