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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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The purpose of this study is to measure the effect of ranolazine on ETT (exercise treadmill test) exercise duration in four ethnic subgroups with established coronary artery disease and risk factor(s) for the metabolic syndrome: Caucasian, African American, Southeast Asian and East Indian.
Studies have shown that various ethnic subgroups are at differential risk for both the development and progression of coronary artery disease. The East Indian population is one of the highest risk populations for coronary artery disease. Much of this increased risk is driven by the development and progression of diabetes.
Recent studies have shown that ranolazine has a favorable effect on glycemic control. In addition, it is an effective antianginal and antiarrhythmic agent.
The investigators propose a pilot study look at the safety, tolerability and efficacy of this agent in patients with established coronary artery disease (CAD) and risk factors for the metabolic syndrome from various ethnic backgrounds. In particular the investigators will focus on the Caucasian, African American, Southeast Asian and East Indian population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranolazine | Active Comparator | Ranolazine in addition to standard of care medical therapy |
|
| Standard of Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranolazine | Drug | Patients in the ranolazine arm would start with 500 mg po BID of ranolazine and be force titrated to 1gm po BID after 2 weeks. Down-titration would only be allowed for side effects. This would be on top of all standard medical therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise Duration | To measure the effect of ranolazine on ETT (exercise treadmill test) exercise duration in four ethnic subgroups with established coronary artery disease and risk factor(s) for the metabolic syndrome: Caucasian, African American, Southeast Asian and East Indian. | change from baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| fasting glucose | To measure the effect ranolazine has on fasting blood glucose. | change from baseline to 6 months |
| Angina | To look at the effect of ranolazine on anginal episodes using the Seattle Angina Questionnaire (SAQ). |
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Inclusion Criteria:
Evidence of stable Coronary Artery Disease
Metabolic Syndrome as evidenced by at least one of the following risk factors:
Abdominal Obesity (elevated waist circumference)
Atherogenic dyslipidemia (either one or both)
Elevated Blood Pressure (equal to or greater than 130/85)
Elevated fasting glucose (equal to or greater than 100 mg/dL)
Symptoms of angina or a suspected angina equivalent (upper body chest pain, shortness of breath, fatigue)
Patient able to perform an exercise treadmill test (ETT)
Written informed consent
Age > 18 years old
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Narendra Singh, MD | Atlanta Heart Specialists, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta Heart Specialist, LLC | Cumming | Georgia | 30041 | United States | ||
| Atlanta Heart Specialists, LLC |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 11, 2019 | |
| Reset | Aug 2, 2019 | |
| Release | Aug 26, 2019 | |
| Reset | Sep 16, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 11, 2019 | Aug 2, 2019 | |||
| Aug 26, 2019 |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000787 | Angina Pectoris |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| 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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|
| change from baseline to 6 months |
| Concomitant medications | To measure the impact of ranolazine on reducing concomitant medication therapy such as anti-arrhythmic agents, hypoglycemic agents, and nitrates. | change from baseline to 6 months |
| lipid profile | To measure the effect ranolazine has on lipid profile. | change from baseline to 6 months |
| HgbA1c | To measure the effect ranolazine has on hemoglobin A1c. | change from baseline to 6 months |
| Tucker |
| Georgia |
| 30084 |
| United States |
| Sep 16, 2019 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| 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 |