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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranolazine/Placebo | Experimental | 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. |
|
| Placebo/Ranolazine | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranolazine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Yue, MD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Imperial Cardiac Center |
Number screened: 222; randomized and treated (RAT; Safety Analysis Set): 81
Efficacy Analysis Set: 61 RAT participants with data for both end-of-period (EOP) scans, completed ≥ 7 consecutive days treatment in each period, took the morning dose before each EOP scan, and had baseline perfusion defect size ≥ 5% as measured by QPS imaging software.
Participants were enrolled in a total of 27 study sites in the United States, Canada, Czech Republic, and Israel. The first participant was screened on 29 September 2010. The last participant observation was on 27 September 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranolazine/Placebo | Period 1: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise gated single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) study. Period 2: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
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| Placebo to match ranolazine | Drug | Placebo to match ranolazine administered in the same form and frequency as the active drug. |
|
| SPECT MPI | Procedure | 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 | Behavioral | Treadmill stress test |
|
| Up to 33 days |
| 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 |
| 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 |
| Imperial |
| California |
| 92251 |
| United States |
| Clinical Trials Research | Lincoln | California | 95648 | United States |
| Mission Internal Medical Group | Mission Viejo | California | 92691 | United States |
| Central Coast Cardiology | Salinas | California | 93901 | United States |
| Alfieri Cardiology | Newark | Delaware | 19713 | United States |
| St. Luke's Cardiology Associates | Jacksonville | Florida | 32216 | United States |
| Cardiovascular Research Center of South Florida | Miami | Florida | 33173 | United States |
| Research One | Orlando | Florida | 32806 | United States |
| Cardiology Partners Clinical Research Institute | Wellington | Florida | 33449 | United States |
| Fox Valley Clinical Research Center, LLC | Aurora | Illinois | 60504 | United States |
| Research Integrity, LLC | Owensboro | Kentucky | 42303 | United States |
| Louisiana Heart Center | Covington | Louisiana | 70403 | United States |
| Louisiana Heart Center | Slidell | Louisiana | 70458 | United States |
| Androscroggin Cardiology Associates DBA Maine Research Associates | Auburn | Maine | 04210 | United States |
| Delmarva Heart Research Foundation, Inc | Salisbury | Maryland | 21804 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Cardiovascular Imaging Technologies | Kansas City | Missouri | 64111 | United States |
| Dr. Michael Sacher | Massapequa | New York | 11758 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Heritage Cardiology | Camp Hill | Pennsylvania | 17011 | United States |
| University of Pittsburgh Medical Center Cardiovascular Institute | Pittsburgh | Pennsylvania | 15213 | United States |
| Kore Cardiovascular Research | Jackson | Tennessee | 38305 | United States |
| East Texas Cardiology PA | Houston | Texas | 77002 | United States |
| Mercury Medical, LLC | San Antonio | Texas | 78229 | United States |
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
| ECOGENE-21 Clinical Trial Center, Chicoutimi Hospital | Chicoutimi | Quebec | G7H 7P2 | Canada |
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
| Chum Hotel Dieu | Montreal | Quebec | H2W 1T8 | Canada |
| University Hospital Kralovske Vinohrady | Prague | 100 34 | Czechia |
| University Hospital Motol | Prague | 150 06 | Czechia |
| Turku University Hospital | Turku | 20520 | Finland |
| Barzilai Medical Center | Ashkelon | 78278 | Israel |
| Soroka Medical Center | Beersheba | 84101 | Israel |
| Rambam Health Care Campus | Haifa | 31096 | Israel |
| Kaplan Medical Center | Rehovot | 76100 | Israel |
| Assuta MC | Tel Aviv | 69710 | Israel |
| "Federico II" University | Naples | 80131 | Italy |
| Federico II University | Naples | 80131 | Italy |
| National University Health System | Singapore | 119228 | Singapore |
| National Heart Centre Singapore | Singapore | 168752 | Singapore |
| Northwick Park Hospital, Watford Road | Middlesex | HA1 3UJ | United Kingdom |
| FG001 | Placebo/Ranolazine | Period 1: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study. Period 2: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study. |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
|
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Safety Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Baseline characteristics were analyzed as a single group (Safety Analysis Set). All participants were assigned to complete the same treatment periods in the same manner. Ranolazine Treatment Period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study. Placebo Treatment Period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Body mass index | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Efficacy Analysis Set: 61 randomized and treated participants with data for both end-of-period (EOP) scans, completed ≥ 7 consecutive days treatment in each period, took the morning dose before each EOP scan, and had baseline perfusion defect size ≥ 5% as measured by QPS imaging software | Posted | Least Squares Mean | Standard Error | percentage of myocardium | Up to 33 days |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Efficacy Analysis Set | Posted | Least Squares Mean | Standard Error | units on a scale | Up to 33 days |
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| 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. | Efficacy Analysis Set | Posted | Mean | Standard Error | percentage of segments | Up to 33 days |
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| 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. | Efficacy Analysis Set | Posted | Mean | Standard Error | percentage of myocardium | Up to 33 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Efficacy Analysis Set | Posted | Mean | Standard Error | units on a scale | Up to 33 days |
|
Up to 33 days
All participants were assigned to complete the ranolazine and placebo treatment periods during the study, the only difference being which treatment period they started first.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Onset Following Ranolazine | This reporting group includes participants dosed with ranolazine and their events for which the last dosed treatment was ranolazine, ie, events with onset during the ranolazine treatment period or during post-ranolazine treatment period follow-up. Ranolazine Treatment Period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study. Placebo Treatment Period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study. | 2 | 80 | 25 | 80 | ||
| EG001 | Onset Following Placebo | This reporting group includes participants dosed with placebo and their events for which the last dosed treatment was placebo, ie, events with onset during the placebo treatment period or during post-placebo treatment period follow-up. Ranolazine Treatment Period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study. Placebo Treatment Period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study. | 0 | 79 | 7 | 79 | ||
| EG002 | Onset at Any Time Following Ranolazine | This reporting group includes participants dosed with ranolazine and their events with onset at any time following ranolazine treatment. Ranolazine Treatment Period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study. Placebo Treatment Period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study. | 2 | 80 | 28 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Electrocardiogram ST segment elevation | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Gilead Sciences, Inc. | ClinicalTrialDisclosures@gilead.com |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000069458 | Ranolazine |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 65 to 74 years |
|
| ≥ 75 years |
|
| Other |
|
| Not Reported |
|
| Unknown |
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| Canada |
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| Israel |
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