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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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Patients with ischemic cardiomyopathy may continue to experience persistent chest pain and shortness of breath despite conventional medical therapy and/or revascularization. The purpose of this study is to determine the efficacy of taking Ranexa versus placebo in patients with ischemic (due to blockages) cardiomyopathy treated with optimal conventional medical therapy and/or percutaneous revascularization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranolazine | Active Comparator | 1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily. |
|
| Placebo | Placebo Comparator | 1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranexa | Drug | 1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anginal Frequency | Anginal frequency as assessed by Seattle Angina Questionnaire. Scoring is done by assessing responses on an ordinal value. Anginal score is scored by the patient by selecting a number from 0 to 100 with low score indicates more anginal frequency. The mean of the the scores of all patients analyzed were compared between placebo and Ranolazine. | 12 weeks |
| Quality of Life Questionnaire | Quality of life as measured by the Seattle Angina Questionnaire as a score ranging from 0 to 100. Higher score indicates better quality of life. The Qaulity of life is scored by the patient. It assesses the perceived satisfaction or dissatisfaction in the major domains of life. These include mobility, self-care, Usual activities (leisure, work, family), Pain/Discomfort, and Anxiety. | 12 weeks |
| Dyspnea Assessed by the Rose Dyspnea Questionnaire (RDQ) | RDQ is a four item questionnaire that evaluates a patient's dyspnea with regular activity. Each question answered postiviely is given a score of 1. Total score possible is 4. A higher score indicates worse dyspnea. A difference between the score at end of treatment minus baseline is performed. A negative score indicates improvement. Comparing the difference between the 2 arms (placebo and ranolazine) is performed. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas W Shammas, MD | Midwest Cardiovascular Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midwest Cardiovascular Research Foundation | Davenport | Iowa | 52803 | United States |
A total of 36 patients assessed for eligibility. Excluded were 8 patients (did not meet inclusion criteria=4; declined to participate=3;other=1). 28 patients were included in this randomized cross-over study.
Participants recruited from a cardiovascular clinic in Davenport, Iowa between 5/21/2012 and 11/22/2013
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranolazine, Then Placebo | Patient received Ranolazine to 1,000 mg ranolazine orally twice a day, as tolerated for 6 weeks. After a washout period of 2 weeks, they then received Placebo tablet (matching Ranolazine 1000 mg tablet twice a week) for 6 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomization Ranolazine/Placebo 6 Weeks |
|
| ||||||||||||||||||
| Crossover Ranolazine/Placebo 6 Weeks |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes both groups randomized to placebo and ranolazine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Anginal Frequency | Anginal frequency as assessed by Seattle Angina Questionnaire. Scoring is done by assessing responses on an ordinal value. Anginal score is scored by the patient by selecting a number from 0 to 100 with low score indicates more anginal frequency. The mean of the the scores of all patients analyzed were compared between placebo and Ranolazine. | Patients receiving ranolazine for 6 weeks and crossed over to placebo or vice versa. Higher number on the angina scale indicates less angina | Posted | Mean | Full Range | units on a scale | 12 weeks |
|
12 weeks
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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 | patients receiving ranolazine | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart failure | Cardiac disorders | Systematic Assessment | patient was admitted to the hospital with exacerbation of his heart failure, but this patient also had pneumonia and sepsis.study drug. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Intolerance to high dose of medication |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Nicolas W Shammas | Midwest Cardiovascular Research Foundation | 5633242828 | shammas@mchsi.com |
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| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D002637 | Chest Pain |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000069458 | Ranolazine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Placebo | Drug | 1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily. |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ejection Fraction | Mean | Standard Deviation | Percentage |
|
| Diabetes Mellitus | Number | participants |
|
| Prior myocardial infarction | Number | participants |
|
|
|
|
| Primary | Quality of Life Questionnaire | Quality of life as measured by the Seattle Angina Questionnaire as a score ranging from 0 to 100. Higher score indicates better quality of life. The Qaulity of life is scored by the patient. It assesses the perceived satisfaction or dissatisfaction in the major domains of life. These include mobility, self-care, Usual activities (leisure, work, family), Pain/Discomfort, and Anxiety. | Posted | Mean | Full Range | units on a scale | 12 weeks |
|
|
|
|
| Primary | Dyspnea Assessed by the Rose Dyspnea Questionnaire (RDQ) | RDQ is a four item questionnaire that evaluates a patient's dyspnea with regular activity. Each question answered postiviely is given a score of 1. Total score possible is 4. A higher score indicates worse dyspnea. A difference between the score at end of treatment minus baseline is performed. A negative score indicates improvement. Comparing the difference between the 2 arms (placebo and ranolazine) is performed. | Patients with dsypnea. The score reflects difference between baseline and following treatment with ranolazine or placebo | Posted | Mean | Full Range | units on a scale | 12 weeks |
|
|
|
|
| 24 |
| 2 |
| 24 |
| 6 |
| 24 |
| EG001 | Placebo | Patients receiving placebo | 0 | 24 | 0 | 24 | 2 | 24 |
|
| stroke | Nervous system disorders | Systematic Assessment | From atrial fibrillation. Unrelated to study medication |
|
|
| diziness | Nervous system disorders | Systematic Assessment | Intolerance to medication |
|
| constipation | Gastrointestinal disorders | Systematic Assessment |
|
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| Aniline Compounds |
| D000588 | Amines |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |