Effect of Ranolazine on Myocardial Perfusion Assessed by Serial Quantitative Exercise SPECT Imaging
NCT ID: NCT01221272
Last Updated: 2014-09-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
81 participants
INTERVENTIONAL
2010-09-30
2012-09-30
Brief Summary
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This was a 2-period crossover study. The last dose of each period must have been taken 3-4 hours prior to conduct of the exercise SPECT MPI. After the research exercise SPECT MPI was performed at the end of Period 1, participants discontinued the treatment they were randomized to for that period and began the other treatment in Period 2.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Ranolazine/Placebo
Participants received ranolazine from Day 1 through Day 15 (± 2 days) of Period 1, followed by an exercise SPECT MPI study, then received placebo to match ranolazine from Day 1 through Day 15 (± 2 days) of Period 2, followed by an exercise SPECT MPI study.
Ranolazine
* One 500 mg tablet in the evening on Day 1 of the period
* One 500 mg tablet, twice daily on Days 2-3 of the period
* Two 500 mg tablets (1000 mg total), twice daily from Day 4 to the end of the period (Day 15 ± 2 days)
Placebo to match ranolazine
Placebo to match ranolazine administered in the same form and frequency as the active drug.
SPECT MPI
Gated single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) to confirm the presence of reversible exercise-induced left ventricular perfusion defect size (PDS) performed within 12 weeks prior to baseline or at the baseline visit, and at the end-of-period 1 and end-of-period 2 visits.
Exercise
Treadmill stress test
Placebo/Ranolazine
Participants received placebo to match ranolazine from Day 1 through Day 15 (± 2 days) of Period 1, followed by an exercise SPECT MPI study, then received ranolazine from Day 1 through Day 15 (± 2 days) of Period 2, followed by an exercise SPECT MPI study.
Ranolazine
* One 500 mg tablet in the evening on Day 1 of the period
* One 500 mg tablet, twice daily on Days 2-3 of the period
* Two 500 mg tablets (1000 mg total), twice daily from Day 4 to the end of the period (Day 15 ± 2 days)
Placebo to match ranolazine
Placebo to match ranolazine administered in the same form and frequency as the active drug.
SPECT MPI
Gated single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) to confirm the presence of reversible exercise-induced left ventricular perfusion defect size (PDS) performed within 12 weeks prior to baseline or at the baseline visit, and at the end-of-period 1 and end-of-period 2 visits.
Exercise
Treadmill stress test
Interventions
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Ranolazine
* One 500 mg tablet in the evening on Day 1 of the period
* One 500 mg tablet, twice daily on Days 2-3 of the period
* Two 500 mg tablets (1000 mg total), twice daily from Day 4 to the end of the period (Day 15 ± 2 days)
Placebo to match ranolazine
Placebo to match ranolazine administered in the same form and frequency as the active drug.
SPECT MPI
Gated single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) to confirm the presence of reversible exercise-induced left ventricular perfusion defect size (PDS) performed within 12 weeks prior to baseline or at the baseline visit, and at the end-of-period 1 and end-of-period 2 visits.
Exercise
Treadmill stress test
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Exercise SPECT MPI study (stress and rest) conducted during screening (after consultation with the Medical Monitor and after informed consent was obtained) showing at least 10% reversible myocardial ischemia (as confirmed by the core nuclear laboratory)
* Stable antianginal medical therapy (excluding short-acting nitroglycerin)
Exclusion Criteria
* Automated implantable defibrillator and/or pacemaker (selected subjects with permanent pacemakers who had an intact sinus mechanism may have been included following consultation with the Medical Monitor)
* Intervening coronary revascularization between the time of qualifying exercise SPECT MPI study and randomization
* Acute myocardial infarction (MI) 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 surgery within 60 days prior to screening or at any time after the qualifying exercise SPECT MPI study, or percutaneous coronary intervention 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 or transient ischemic attack within 90 days prior to screening
* History of serious arrhythmias
* Current atrial fibrillation or atrial flutter
* QTc interval \> 500 milliseconds
* Diagnosed as having New York Heart Association Class III or IV heart failure
* Inability to exercise or exercise limitation due to other comorbidities that may have interfered with ability to perform required exercise SPECT MPI study
* Body mass index greater than or equal to 38 kg/m\^2 (may have been up to 40 kg/m\^2 after consultation with the Medical Monitor)
* Any absolute contraindications to exercise stress testing
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Patrick Yue, MD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Imperial Cardiac Center
Imperial, California, United States
Clinical Trials Research
Lincoln, California, United States
Mission Internal Medical Group
Mission Viejo, California, United States
Central Coast Cardiology
Salinas, California, United States
Alfieri Cardiology
Newark, Delaware, United States
St. Luke's Cardiology Associates
Jacksonville, Florida, United States
Cardiovascular Research Center of South Florida
Miami, Florida, United States
Research One
Orlando, Florida, United States
Cardiology Partners Clinical Research Institute
Wellington, Florida, United States
Fox Valley Clinical Research Center, LLC
Aurora, Illinois, United States
Research Integrity, LLC
Owensboro, Kentucky, United States
Louisiana Heart Center
Covington, Louisiana, United States
Louisiana Heart Center
Slidell, Louisiana, United States
Androscroggin Cardiology Associates DBA Maine Research Associates
Auburn, Maine, United States
Delmarva Heart Research Foundation, Inc
Salisbury, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Cardiovascular Imaging Technologies
Kansas City, Missouri, United States
Dr. Michael Sacher
Massapequa, New York, United States
Columbia University Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Heritage Cardiology
Camp Hill, Pennsylvania, United States
University of Pittsburgh Medical Center Cardiovascular Institute
Pittsburgh, Pennsylvania, United States
Kore Cardiovascular Research
Jackson, Tennessee, United States
East Texas Cardiology PA
Houston, Texas, United States
Mercury Medical, LLC
San Antonio, Texas, United States
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
ECOGENE-21 Clinical Trial Center, Chicoutimi Hospital
Chicoutimi, Quebec, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Chum Hotel Dieu
Montreal, Quebec, Canada
University Hospital Kralovske Vinohrady
Prague, , Czechia
University Hospital Motol
Prague, , Czechia
Turku University Hospital
Turku, , Finland
Barzilai Medical Center
Ashkelon, , Israel
Soroka Medical Center
Beersheba, , Israel
Rambam Health Care Campus
Haifa, , Israel
Kaplan Medical Center
Rehovot, , Israel
Assuta MC
Tel Aviv, , Israel
"Federico II" University
Naples, , Italy
Federico II University
Naples, , Italy
National University Health System
Singapore, , Singapore
National Heart Centre Singapore
Singapore, , Singapore
Northwick Park Hospital, Watford Road
Middlesex, , United Kingdom
Countries
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Other Identifiers
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GS-US-259-0103
Identifier Type: -
Identifier Source: org_study_id
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