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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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This is a prospective, double-blind, placebo-controlled, randomized, single-center (North Florida- South Georgia VA Medical Center) study. The study objective is to determine if ranolazine improves angina symptoms at 4 months compared with placebo among stable coronary artery disease patients who have demonstrable myocardial ischemia, but who do not undergo revascularization
This is a prospective, double-blind, placebo-controlled, randomized, single-center (North Florida- South Georgia VA Medical Center) study. The study objective is to determine if ranolazine improves angina symptoms at 4 months compared with placebo among stable coronary artery disease patients who have demonstrable myocardial ischemia, but who do not undergo revascularization.
Baseline Procedure:
Assessments performed exclusively to determine eligibility for this study would be done only after obtaining informed consent. Assessments performed for clinical indications (not exclusively to determine study eligibility) may be used for baseline values even if the studies were done before informed consent was obtained. The assessment will include:
Screening Visit:
The assessments to determine eligibility are:
Drug schedule will be as follows:
Telephone Follow-up:
One week phone calls will be made to determine well being, adverse events, answer questions and remind subjects to increase the study medication dose.
Month 4 Follow-up:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranolazine | Active Comparator | Ranolazine 500 mg tablets
|
|
| Sugar pill | Placebo Comparator | Sugar pill that looks like the drug ranolazine 500mg tablet
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranolazine | Drug | Ranolazine 500mg tablet
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Seattle Angina Questionnaire Score Change From Baseline to 16 Weeks | The SAQ quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life.Each of the 5 dimensions are scored by assigning eachresponse an ordinal value, beginning with 1 for the response that implies the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range1 / 3 Seattle Angina Questionnaire (SAQ)of the scale and multiplying by 100. No overall scale score is generated. Factors and Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life). . | Change in baseline to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Well Being | overall feeling of well being determined from rating of excellent, good, fair or poor at baseline compared to same at month 4 | Compare from baseline to month 4 |
| Ischemia Driven Revascularization or Hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony A Bavry, MD, MPH | NorthFlorida/South Georgia Veterans Health System, Gainesville, FL 32608 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Florida/South Georgia Veterans Health System | Gainesville | Florida | 32608 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28044265 | Background | Bavry AA, Park KE, Choi CY, Mahmoud AN, Wen X, Elgendy IY. Improvement of Subjective Well-Being by Ranolazine in Patients with Chronic Angina and Known Myocardial Ischemia (IMWELL Study). Cardiol Ther. 2017 Jun;6(1):81-88. doi: 10.1007/s40119-016-0081-3. Epub 2017 Jan 2. |
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recruitment period first subject enrolled 9/24/2014 to last subject enrolled 12/12/2015
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranolazine | Ranolazine 500 mg tablets
Ranolazine: Ranolazine 500mg tablet
|
| FG001 | Sugar Pill | Sugar pill that looks like the drug ranolazine 500mg tablet
Sugar pill: 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranolazine | Ranolazine 500 mg tablets
Ranolazine: Ranolazine 500mg tablet
|
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Seattle Angina Questionnaire Score Change From Baseline to 16 Weeks | The SAQ quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life.Each of the 5 dimensions are scored by assigning eachresponse an ordinal value, beginning with 1 for the response that implies the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range1 / 3 Seattle Angina Questionnaire (SAQ)of the scale and multiplying by 100. No overall scale score is generated. Factors and Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life). . | by intention to treat, 46 subjects had baseline and follow up SAQ data completed at 16 weeks | Posted | Mean | Standard Deviation | units on a scale | Change in baseline to 16 weeks |
|
Baseline to 16 weeks
adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.
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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 | Ranolazine | Ranolazine 500 mg tablets
Ranolazine: Ranolazine 500mg tablet
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| lung mass | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | standard terminology | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anxiety | Psychiatric disorders | standard terminology | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anthony Bavry | Malcom Randall VA Medical Center | 352-376-1611 | 6325 | anthony.bavry@va.gov |
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| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000069458 | Ranolazine |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Sugar pill | Drug |
|
|
|
Number of participants who reported adverse events for ischemia driven revascularization or hospitalization
| 4 month |
| Withdrawal by Subject |
|
| Sugar Pill |
Sugar pill that looks like the drug ranolazine 500mg tablet
Sugar pill: 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hypertension | Count of Participants | Participants |
|
| Hyperlipidemia | Count of Participants | Participants |
|
| Diabetes mellitus | Count of Participants | Participants |
|
| on Insulin | Count of Participants | Participants |
|
| history of Percutaneous Coronary Intervention | Count of Participants | Participants |
|
| history of Coronary Artery Bypass Graft surgery | Count of Participants | Participants |
|
| OG000 | Ranolazine | Ranolazine 500 mg tablets
Ranolazine: Ranolazine 500mg tablet
|
| OG001 | Sugar Pill | Sugar pill that looks like the drug ranolazine 500mg tablet
Sugar pill: 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks |
|
|
|
| Secondary | Subjective Well Being | overall feeling of well being determined from rating of excellent, good, fair or poor at baseline compared to same at month 4 | Posted | Count of Participants | Participants | Compare from baseline to month 4 |
|
|
|
|
| Secondary | Ischemia Driven Revascularization or Hospitalization | Number of participants who reported adverse events for ischemia driven revascularization or hospitalization | the incidence of ischemia driven hospitalization or catheterization was assessed for all subjects. | Posted | Count of Participants | Participants | 4 month |
|
|
|
|
| 1 |
| 25 |
| 5 |
| 25 |
| 17 |
| 25 |
| EG001 | Sugar Pill | Sugar pill that looks like the drug ranolazine 500mg tablet
Sugar pill: 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks | 0 | 25 | 4 | 25 | 15 | 25 |
| death | Cardiac disorders | standard terminology | Systematic Assessment |
|
| bradycardia, symptomatic | Cardiac disorders | standard terminology | Systematic Assessment |
|
| Unstable Angina | Cardiac disorders | standard terminology | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | standard terminology | Systematic Assessment |
|
| Myocardial Infarctoin | Cardiac disorders | standard terminology | Systematic Assessment |
|
| chest pain | Cardiac disorders | standard terminology | Systematic Assessment |
|
| coronary artery disease | Cardiac disorders | standard terminology | Systematic Assessment | Coronary artery bypass surgery |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | standard terminology | Systematic Assessment |
|
| dizziness | Nervous system disorders | standard terminology | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | standard terminology | Systematic Assessment |
|
| Fainting | Nervous system disorders | standard terminology | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | standard terminology | Systematic Assessment |
|
| worsening renal function | Renal and urinary disorders | standard terminology | Systematic Assessment |
|
| Leg cramps | Musculoskeletal and connective tissue disorders | standard terminology | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | standard terminology | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | standard terminology | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | standard terminology | Systematic Assessment |
|
| Lethargy | Nervous system disorders | standard terminology | Systematic Assessment |
|
| Fall | Musculoskeletal and connective tissue disorders | standard terminology | Systematic Assessment |
|
| productive cough | Respiratory, thoracic and mediastinal disorders | standard terminology | Systematic Assessment |
|
| Confusion | Nervous system disorders | standard terminology | Systematic Assessment |
|
| Black stools | Gastrointestinal disorders | standard terminology | Systematic Assessment |
|
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| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002241 | Carbohydrates |
| missing |
|
| 16 Weeks |
|
| 0.80 |
| Superiority |
| within group analysis of change from baseline for excellent/good | McNemar | 0.50 | Superiority |
| within group comparison of change from baseline for fair/poor | McNemar | 0.48 | Superiority |
| within group analysis of change from baseline for excellent/good | McNemar | 0.19 | Superiority |
| within group comparison of change from baseline for fair/poor | McNemar | 0.067 | Superiority |