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low recruitement rates
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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The investigators hypothesize that ranolazine would decrease the incidence of recurrence of Atrial Fibrillation (AF) after electrical cardioversion of persistent AF. Patients with persistent AF who are candidates for electrical cardioversion will be randomized to either placebo or ranolazine after successful electrical cardioversion.
Atrial fibrillation (AF) is the most common clinically significant cardiac arrhythmia and is associated with increased cardiovascular morbidity and mortality. Although a rhythm control strategy offers no survival benefit over a rate control strategy, elective electrical cardioversion is still recommended in patients without hemodynamic instability for symptomatic relief. However, recurrences are frequent after cardioversion and antiarrhythmic medications are required to maintain sinus rhythm. Nonetheless, the use of antiarrhythmic medications is problematic because of the risk of serious potential adverse effects, including drug-induced ventricular arrhythmias.
Ranolazine is a novel antianginal agent, which inhibits the late inward sodium current and produces antiischemic effects without reducing heart rate or blood pressure. Additionally, recent preclinical as well as preliminary clinical data suggest that ranolazine exhibits distinct antiarrhythmic properties. However, there is no controlled data for the use of ranolazine to prevent recurrence of AF after electrical cardioversion of persistent AF.
The investigators hypothesize that ranolazine would decrease the incidence of recurrence of AF after electrical cardioversion of persistent AF. Patients with persistent AF who are candidates for electrical cardioversion will be randomized to either placebo or ranolazine after successful electrical cardioversion. They will be followed at 2 weeks, 1, 3 and 6 months for clinical evaluation and electrocardiography for the detection of recurrence of AF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranolazine | Experimental | Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated. |
|
| Placebo | Placebo Comparator | Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranolazine | Drug | Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome - Number of Participants With Atrial Fibrillation | To determine if ranolazine is effective in decreasing recurrences of AF in patients with persistent AF successfully treated with electrical cardioversion. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Udho Thadani, MD | University of Oklahoma | Principal Investigator |
| Stavros Stavrakis, MD | University of Oklahoma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oklahoma City VA Medical Center | Oklahoma City | Oklahoma | 73104 | United States | ||
| OU Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranolazine | Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated. Ranolazine: Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months. |
| FG001 | Placebo | Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion. Matching placebo: Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranolazine | Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated. Ranolazine: Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months. |
| 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 | Primary Outcome - Number of Participants With Atrial Fibrillation | To determine if ranolazine is effective in decreasing recurrences of AF in patients with persistent AF successfully treated with electrical cardioversion. | Posted | Number | participants | 6 months |
|
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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 will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated. Ranolazine: Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stavros Stavrakis | University of Oklahoma Health Sciences Center | 405-271-9696 | 37539 | stavros-stavrakis@ouhsc.edu |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000069458 | Ranolazine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Matching placebo | Drug | Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months. |
|
|
| Oklahoma City |
| Oklahoma |
| 73104 |
| United States |
| BG001 | Placebo | Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion. Matching placebo: Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Placebo | Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion. Matching placebo: Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months. | 0 | 5 | 0 | 5 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |