Myocardial Ischemia Clinical Trial
Official title:
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
This study enrolled participants with documented exercise-induced myocardial ischemia in
order to evaluate whether ranolazine, when taken prior to exercise, can improve blood flow
to the heart (myocardial perfusion), as assessed by exercise-induced myocardial perfusion
defect size (PDS) and total perfusion deficit (TPD), using gated single photon emission
computed tomography (SPECT) myocardial perfusion imaging (MPI).
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.
Status | Completed |
Enrollment | 81 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Key Inclusion Criteria: - Exercise SPECT MPI study (stress and rest) showing at least 10% reversible myocardial ischemia (as confirmed by the core nuclear laboratory using Corridor4DM imaging software) 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 was 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 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | ECOGENE-21 Clinical Trial Center, Chicoutimi Hospital | Chicoutimi | Quebec |
Canada | Chum Hotel Dieu | Montreal | Quebec |
Canada | Montreal Heart Institute | Montreal | Quebec |
Canada | University of Ottawa Heart Institute | Ottawa | Ontario |
Czech Republic | University Hospital Kralovske Vinohrady | Praha 10 | |
Czech Republic | University Hospital Motol | Praha 5 | |
Finland | Turku University Hospital | Turku | |
Israel | Barzilai Medical Center | Ashkelon | |
Israel | Soroka Medical Center | Beer Sheva | |
Israel | Rambam Health Care Campus | Haifa | |
Israel | Kaplan Medical Center | Rehovot | |
Israel | Assuta MC | Tel Aviv | |
Italy | "Federico II" University | Naples | |
Italy | Federico II University | Naples | |
Singapore | National Heart Centre Singapore | Singapore | |
Singapore | National University Health System | Singapore | |
United Kingdom | Northwick Park Hospital, Watford Road | Middlesex | |
United States | Androscroggin Cardiology Associates DBA Maine Research Associates | Auburn | Maine |
United States | Fox Valley Clinical Research Center, LLC | Aurora | Illinois |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Heritage Cardiology | Camp Hill | Pennsylvania |
United States | Louisiana Heart Center | Covington | Louisiana |
United States | Duke University Medical Center | Durham | North Carolina |
United States | East Texas Cardiology PA | Houston | Texas |
United States | Imperial Cardiac Center | Imperial | California |
United States | Kore Cardiovascular Research | Jackson | Tennessee |
United States | St. Luke's Cardiology Associates | Jacksonville | Florida |
United States | Cardiovascular Imaging Technologies | Kansas City | Missouri |
United States | Clinical Trials Research | Lincoln | California |
United States | Dr. Michael Sacher | Massapequa | New York |
United States | Cardiovascular Research Center of South Florida | Miami | Florida |
United States | Mission Internal Medical Group | Mission Viejo | California |
United States | Columbia University Medical Center | New York | New York |
United States | Alfieri Cardiology | Newark | Delaware |
United States | Research One | Orlando | Florida |
United States | Research Integrity, LLC | Owensboro | Kentucky |
United States | University of Pittsburgh Medical Center Cardiovascular Institute | Pittsburgh | Pennsylvania |
United States | Central Coast Cardiology | Salinas | California |
United States | Delmarva Heart Research Foundation, Inc | Salisbury | Maryland |
United States | Mercury Medical, LLC | San Antonio | Texas |
United States | Louisiana Heart Center | Slidell | Louisiana |
United States | Cardiology Partners Clinical Research Institute | Wellington | Florida |
Lead Sponsor | Collaborator |
---|---|
Gilead Sciences |
United States, Canada, Czech Republic, Finland, Israel, Italy, Singapore, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Exercise-induced Perfusion Defect Size (PDS) Following Ranolazine and Placebo Treatment | PDS is the amount (percent) of the myocardium with decreased blood flow. A lower percentage means more of the myocardium is receiving blood flow. Measurements were obtained by gated single photon emission computed tomography (SPECT) imaging following exercise at the end of the ranolazine and placebo treatment periods. | Up to 33 days | No |
Primary | Exercise-induced Total Perfusion Deficit (TPD) Following Ranolazine and Placebo Treatment | TPD is a score that measures the overall impact of a region of decreased myocardial blood flow, incorporating both the amount and severity of the decreased flow. TPD is measured on a scale of 0-100, with higher scores being worse and lower scores being better. Measurements were obtained by SPECT imaging following exercise at the end of the ranolazine and placebo treatment periods. | Up to 33 days | No |
Secondary | Perfusion Defect Severity at Baseline, End of Period 1, and End of Period 2 | Perfusion defect severity was assessed for each participant as the percentage of the 17 myocardium segments with a relative perfusion defect score of 3 or 4 on a 0-4 scale. Segment scores are: 0 = normal perfusion; 1 = mild reduction in counts-not definitely abnormal; 2 = moderate reduction in counts-definitely abnormal; 3 = severe reduction in counts; 4 = absent uptake (lower scores correspond to less severity and higher scores correspond to increased severity). A lower percentage means fewer segments have severely reduced blood flow. Measurements were obtained by SPECT imaging following exercise at baseline and at the end of Periods 1 and 2. | Up to 33 days | No |
Secondary | Exercise-induced Reversible Perfusion Defect Size (PDS) at Baseline, End of Period 1, and End of Period 2 | Exercise-induced reversible PDS was derived as the exercise PDS at baseline and at the end of Periods 1 and 2 minus the resting PDS at baseline. A lower percentage means more of the myocardium is receiving blood flow. Measurements were obtained by SPECT imaging at baseline both at rest and following exercise and following exercise at the end of Periods 1 and 2. | Up to 33 days | No |
Secondary | Exercise-induced Reversible Total Perfusion Deficit (TPD) at Baseline, End of Period 1, and End of Period 2 | Exercise-induced reversible TPD was derived as the exercise TPD at baseline and at the end of Periods 1 and 2 minus the resting TPD at baseline. TPD is measured on a scale of 0-100, with higher scores being worse and lower scores being better. Measurements were obtained by SPECT imaging at baseline both at rest and following exercise and following exercise at the end of Periods 1 and 2. | Up to 33 days | No |
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