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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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Ranolazine is an effective and remarkably safe agent for the treatment of patients with chronic stable angina, but its inhibition of voltage gated potassium channels and electrocardiogram (EKG) corrected QT (QTc) prolongation properties have lead many to question its safety when combined with antiarrhythmic drugs. The investigators have proposed a study to determine the safety of ranolazine in patients with chronic stable angina who also take amiodarone. And are conducting a prospective single-center randomized single-blinded placebo controlled trial to run out of our large cardiology practice setting at Cardiovascular Consultants of Nevada. The hypothesis is that there will be no difference in the ventricular arrhythmia burden. The primary outcome will be the measurement of ventricular arrhythmia episodes on serial holter monitor and other serially acquired recordings (such as electrocardiogram, pacemaker or implantable defibrillator (ICD) data, and stress test data) over a three month trial period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sugar pill | Placebo Comparator | one pill twice daily, uptitrated to two pills twice daily to mirror ranolazine prescription strategy |
|
| Ranolazine | Active Comparator | 500 mg twice daily, titrated to 1000 mg twice daily if needed for relief of anginal symptoms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranolazine | Drug | ranolazine 500mg twice daily, may increase to 1000 mg twice daily for therapy optimization in treating chronic stable angina |
|
| Measure | Description | Time Frame |
|---|---|---|
| ventricular arrhythmia | primary outcome is the burden of ventricular arrhythmias measured on serial holter monitor recordings, stress test recordings, pacemaker or implantable defibrillator (ICD) recordings if available, at baseline and serially to trial completion. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| atrial arrhythmia burden | burden of atrial arrhythmias will be measured on serial holter monitor recordings | 3 months |
| Electrocardiogram (EKG) corrected QT (QTc) interval measurement | The electrocardiogram (EKG) corrected QT (QTc) interval be quantitated at baseline and serially to trial completion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erik J Sirulnick, MD | Contact | 702-731-8224 | erikmd@me.com | |
| Christie Abano, RN | Contact | 702-731-8224 | cabano@ccnv.com |
| Name | Affiliation | Role |
|---|---|---|
| Erik J SIrulnick, MD | Cardiovascular Consultants of Nevada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Consultants of Nevada | Recruiting | Henderson | Nevada | 89052 | United States | |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 6, 2015 | |
| Reset | May 21, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 6, 2015 | May 21, 2015 |
| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D003324 | Coronary Artery Disease |
| D001281 | Atrial Fibrillation |
| D017180 | Tachycardia, Ventricular |
| D001145 | Arrhythmias, Cardiac |
| 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 | Drug | one pill twice daily, to increase to two pills twice daily to mirror standard ranolazine treatment strategy |
|
| over the 3 month trial |
| hospitalization | Hospitalization rates, if any, will be serially quantitated to trial completion | 3 months |
| syncope hospitalization | syncope hospitalization rate quantitation to trial completion | 3 months |
| liver function assay | serum liver function testing will be conducted at baseline and serially to trial completion | 3 months |
| Cardiovascular Consultants of Nevada |
| Recruiting |
| Las Vegas |
| Nevada |
| 89144 |
| United States |
| Cardiovascular Consultants of Nevada | Recruiting | Las Vegas | Nevada | 89196 | United States |
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D010335 | Pathologic Processes |
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |
| Aniline Compounds |
| D000588 | Amines |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |