Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation Rates in Post-Operative Cardiac Surgery Patients

Conditions
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Atrial Fibrillation New Onset, Hemorrhage, Prolonged QTc Interval, Ventricular Tachycardia, Medical Care; Complications, Late Effect of Complications

Intervention / Treatment
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* Drug: Ranolazine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Male and female candidates (18 years of age and older) undergoing coronary bypass grafting surgery or valve repair or replacement - Aortic or Tricuspid or Pulmonary valves Patients who are not previously on Ranolazine Do not have a history of arrhythmia and are not on any antiarrhythmic therapy Patients with QTc on a 12 lead EKG of less than or equal to 460 ms Patients with estimated Glomerular Filtration Rate (GFR) greater than 30 mL/min/1.73 m2 on the initial lab work Available at least 48 hours before surgery Exclusion criteria: Patients who are not undergoing above surgeries Patients undergoing surgery for mitral valve replacement/repair Patient with cirrhosis Pregnant patients Patients with chronic atrial fibrillation Patients who had prior adverse drug reactions or allergies to Ranolazine Patients who are already taking Ranolazine prior to the study Patient who are reported HIV Positive (as there are antiretroviral drug interactions) Patients who are on drugs listed in Appendix A prior to the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ranolazine<br>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. | Drug: Ranolazine<br>* 1000mg, two times a day, 12 hour intervals<br>* Other names: RANEXA®;|
| Placebo Comparator: Placebo<br>Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals) | Drug: Placebo<br>* two times a day, 12 hour intervals<br>* Other names: Sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of New Onset Atrial Fibrillation Rate in Post-Operative Cardiac Surgery Patients |  | 3 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation New Onset, Ranolazine, CABG, valve repair/replacement, Cardiac Surgery