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The purpose of this study is to determine the effects of ranolazine on different markers of cardiometabolic disease in women with stable angina.
Evaluate the ability of ranolazine to favorably modify thrombogenic, inflammatory, lipogenic, oxidative stress and hormonal biomarkers in a relatively short period of time in a group of ethnically diverse women with chronic stable angina and metabolic syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranolazine | Experimental | Ranolazine would start with 500 mg BID and be force titrated to 1 gram po BID after 3 weeks. Down titration would only be allowed for side effects. This would be on top of all standard medical therapy. |
|
| Placebo | Placebo Comparator | Placebo arm would start with 500 mg matching placebo tablet BID and be force titrated to 1 gram matching placebo tablet twice a day after 3 weeks. Down titration would only be allowed for side effects (if reported). This would be on top of all standard medical therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranolazine | Drug | Ranolazine 500 mg from baseline to week 3 and 1000 mg thereafter until week 24 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Ranolazine on Hemoglobin A1C | Will evaluate the impact of ranolazine in HgbA1C in women with Metabolic Syndrome (MBS) | Change from baseline to 24 weeks |
| Impact of Ranolazine on HDL-C Levels in Subjects | Will evaluate the impact of ranolazine in HDL-C levels in women with metabolic syndrome | Change from Baseline to 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gladys P Velarde, MD, FACC | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Jacksonville | Florida | 32209 | United States |
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Recruitment period: 7/21/14 - 7/2/18 Location: UF Jacksonville Outpatient Cardiology clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranolazine | Ranolazine would start with 500 mg BID and be force titrated to 1 gram po BID after 3 weeks. Down titration would only be allowed for side effects. This would be on top of all standard medical therapy. Ranolazine: Ranolazine 500 mg from baseline to week 3 Ranolazine: Ranolazine 1000mg daily at week 3 until weeks 24. |
| FG001 | Placebo | Placebo arm would start with 500 mg matching placebo tablet BID and be force titrated to 1 gram matching placebo tablet twice a day after 3 weeks. Down titration would only be allowed for side effects (if reported). This would be on top of all standard medical therapy. Placebo: Matching placebo tablets daily for 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Starting Dose Ranolazine 500 mg BID |
|
| |||||||||||||||||||||
| Titrated to Ranolazine 1000mg BID |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranolazine | Ranolazine would start with 500 mg BID and be force titrated to 1 gram po BID after 3 weeks. Down titration would only be allowed for side effects. This would be on top of all standard medical therapy. Ranolazine: Ranolazine 500 mg from baseline to week 3 Ranolazine: Ranolazine 1000mg daily at week 3 until weeks 24. |
| 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 | Impact of Ranolazine on Hemoglobin A1C | Will evaluate the impact of ranolazine in HgbA1C in women with Metabolic Syndrome (MBS) | Posted | Mean | Standard Deviation | percent change | Change from baseline to 24 weeks |
|
Patients were followed for 24 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 Treated | Ranolazine would start with 500 mg BID and be force titrated to 1 gram po BID after 3 weeks. Down titration would only be allowed for side effects. This would be on top of all standard medical therapy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| upset stomach | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gladys Velarde, MD | University of Florida, Jacksonville | 904-244-2060 | gladys.velarde@jax.ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 25, 2017 | Feb 5, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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 | Other | Matching placebo tablets daily for 24 weeks. |
|
| Adverse Event |
|
| NOT COMPLETED |
|
|
| Placebo |
Placebo arm would start with 500 mg matching placebo tablet BID and be force titrated to 1 gram matching placebo tablet twice a day after 3 weeks. Down titration would only be allowed for side effects (if reported). This would be on top of all standard medical therapy. Placebo: Matching placebo tablets daily for 24 weeks. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Impact of Ranolazine on HDL-C Levels in Subjects | Will evaluate the impact of ranolazine in HDL-C levels in women with metabolic syndrome | Posted | Mean | Standard Deviation | percentage of change in HDL | Change from Baseline to 24 weeks |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 3 |
| 16 |
| EG001 | Placebo | Placebo arm would start with 500 mg matching placebo tablet BID and be force titrated to 1 gram matching placebo tablet twice a day after 3 weeks. Down titration would only be allowed for side effects (if reported). This would be on top of all standard medical therapy. | 0 | 17 | 0 | 17 | 0 | 17 |
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| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |