Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery

Study Overview
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Brief Summary
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The objective of this study is to show that ranolazine is a safe, viable and potent alternative for post-operative atrial fibrillation suppression in patients undergoing cardiac surgery

Detailed Description
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A single center, double blind, prospective, randomized study for patients who are scheduled for elective cardiac surgery (Coronary Artery Bypass Graft [CABG], or valve or CABG and valve). All patients who meet criteria will be prospectively enrolled in a randomized fashion. Patients enrolled will be assigned to receive twice daily identical capsules containing either placebo or ranolazine. Study drug will be initiated 2 days before surgery. Patients will receive study drug throughout their hospitalization and be kept on it for a full 2 weeks post operatively. Patients will be seen in 2 weeks and receive a 30 day follow up contact visit.

Official Title
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Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery

Conditions
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Heart; Dysfunction Postoperative, Cardiac Surgery

Intervention / Treatment
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* Drug: Ranolazine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indications for cardiac surgery (CABG, valve surgery or CABG and valve surgery, Able to provide informed consent. Exclusion Criteria: Documented atrial fibrillation within the previous 3 months Ongoing therapy with suppressive antiarrhythmic drugs Patient currently on digoxin Emergent surgery Patient receiving hemodialysis Concomitant use of ketoconazole, diltiazem, verapamil Known tolerance or hypersensitivity to ranolazine Pregnant individuals MAZE procedure (is a surgical ablation to treat atrial fibrillation) performed during concurrent cardiac surgery

Ages Eligible for Study
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Minimum Age: 22 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CABG surgery with Ranolazine<br>Patient will undergo Coronary Artery Bypass Graft (open heart surgery) and will receive, Ranolazine 1000 mg (2-500mg tablets) twice daily. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg (1-500mg tablet) twice daily. | Drug: Ranolazine<br>* Ranolazine 1000mg (2-500mg tablets) twice daily. Starting 2 days prior to surgery, morning of surgery and up to 14 days post operative depending when the breathing tube is removed from the patient post operative. If intolerant to the study drug due to adverse effects or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500mg (1-500mg tablet) twice daily<br>* Other names: Ranexa;|
| Placebo Comparator: CABG surgery with placebo<br>Patient will undergo Coronary Artery Bypass Graft (open heart surgery) and will receive, Placebo 1000mg mg (2-500mg tablets)twice daily. If intolerant to the study drug due to adverse effects, or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500mg (1-500mg tablet) twice daily. | Drug: Placebo<br>* Placebo 1000mg (2-500mg tablets) twice daily. Starting 2 days prior to surgery, morning of surgery and up to 14 days post operative depending when the breathing tube is removed from the patient post operative. If intolerant to the study drug due to adverse effects or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500mg (1-500mg tablet) twice daily<br>* Other names: inactive ingredients pill;|
| Active Comparator: Heart Valve surgery with Ranolazine<br>Patient will undergo heart Valve surgery and will receive, Ranolazine1000mg (2-500 mg tablets) twice a day. If intolerant to the study drug due to adverse effects, or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg (1-500mg tablet) twice a day. | Drug: Ranolazine<br>* Ranolazine 1000mg (2-500mg tablets) twice daily. Starting 2 days prior to surgery, morning of surgery and up to 14 days post operative depending when the breathing tube is removed from the patient post operative. If intolerant to the study drug due to adverse effects or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500mg (1-500mg tablet) twice daily<br>* Other names: Ranexa;|
| Placebo Comparator: Heart Valve surgery with placebo<br>Patient will undergo heart Valve surgery and will receive, Placebo 1000mg (2-500mg tablets) twice a day. If intolerant to the study drug due to adverse effects, or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500mg (1-500mg tablet) twice a day. | Drug: Placebo<br>* Placebo 1000mg (2-500mg tablets) twice daily. Starting 2 days prior to surgery, morning of surgery and up to 14 days post operative depending when the breathing tube is removed from the patient post operative. If intolerant to the study drug due to adverse effects or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500mg (1-500mg tablet) twice daily<br>* Other names: inactive ingredients pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom From Any Episode of Post Operative Atrial Fibrillation Longer Than 6 Hours Duration Occurring During the Study Period. | Freedom from any episode of post operative Atrial Fibrillation (AF) longer than 6 hours duration occurring during the study period. To document post operative atrial fibrillation. | The time between the completion of the operation and hospital discharge or 14 days post operative if the hospitalzation is prolonged | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suppress Atrial Fibrillation, heart bypass surgery, heart valve surgery