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The study was terminated due to slow rate of accrual resulting in a sample size.
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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The aim of this study is to evaluate the prophylactic effects of Ranolazine on new onset atrial fibrillation in post-operative coronary artery bypass graft and valve surgery patient population at Staten Island University hospital.
Atrial fibrillation (AF) is a common complication of cardiac surgery. It has been shown that the onset of AF increases in post-operative cardiac surgery population. The rate of AF after coronary artery bypass graft (CABG) procedure range from 10-65% and from 37-50% after valve surgery. Rates of new onset AF are lower for CABG compared to valve procedures. The pathophysiology of post-operative AF is not well elucidated. It has been postulated that pre-operative factors such as age, past medical history, operative and post-operative remodeling of the coronary system and hemodynamic pressure changes may contribute to post-operative AF.
Ranolazine is currently approved as an antianginal drug. The antianginal properties of the drug are due to inhibition of the late inward sodium current. Through the same mechanism it has been demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias.
Therefore it is important to prevent or minimize the incidence of new onset post-operative AF in post-surgical population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranolazine | Active Comparator | The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias. |
|
| Placebo | Placebo Comparator | Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranolazine | Drug | 1000mg, two times a day, 12 hour intervals |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of New Onset Atrial Fibrillation Rate in Post-Operative Cardiac Surgery Patients | 3 weeks after surgery |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soad Bekheit, MD | Staten Island University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Staten Island University Hosptial | Staten Island | New York | 10305 | United States |
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| Label | URL |
|---|---|
| The conversion of paroxysmal or initial onset atrial fibrillation with oral Ranolazine: Implications for a new "pill-in-pocket" approach in structural heart disease. | View source |
| Comparison of effectiveness and safety of Ranolazine versus amiodarone for preventing atrial fibrillation after coronary artery bypass grafting. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranolazine | The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias. Ranolazine: 1000mg, two times a day, 12 hour intervals |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | two times a day, 12 hour intervals |
|
|
| Electrophysiologic basis for the antiarrhythmic actions of Ranolazine. Heart Rhythm. | View source |
Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals) Placebo: two times a day, 12 hour intervals |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranolazine | The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias. Ranolazine: 1000mg, two times a day, 12 hour intervals |
| BG001 | Placebo | Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals) Placebo: two times a day, 12 hour intervals |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Incidence of New Onset Atrial Fibrillation Rate in Post-Operative Cardiac Surgery Patients | Fifty-four patients were randomized with a mean follow-up of 25 months and none were lost to follow-up. The study was terminated due to slow rate of accrual resulting in a sample size of 27 ranolazine and 27 placebo. | Posted | Count of Participants | Participants | 3 weeks after surgery |
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Post op (days 1-6); hospital discharge; Post -op follow up (2-3 weeks); Follow up call (day 28).
Patients were given a medication log post discharge to note when medication was taken and to note any other comments related to how they were feeling.
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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 | The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias. Ranolazine: 1000mg, two times a day, 12 hour intervals | 0 | 27 | 4 | 27 | ||
| EG001 | Placebo | Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals) Placebo: two times a day, 12 hour intervals | 0 | 27 | 3 | 27 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dizziness | General disorders | Systematic Assessment |
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Due to insufficient accrual rate the study was stopped before the recruitment total was met. Thus, a major limitation is small sample size.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Soad Bekheit, MD | Staten Island University Hospital, Northwell Health | 718-226-6629 | msills@northwell.edu |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
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| ID | Term |
|---|---|
| D000069458 | Ranolazine |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002241 | Carbohydrates |
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| >=65 years |
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| Male |
|