Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery

Phase 3

Terminated

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
CABG surgery with placebo	Placebo	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.
Heart Valve surgery with placebo	Placebo	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.
CABG surgery with Ranolazine	Ranolazine	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.
Heart Valve surgery with Ranolazine	Ranolazine	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.

Primary Outcome Measures

Name	Time	Method
Freedom From Any Episode of Post Operative Atrial Fibrillation Longer Than 6 Hours Duration Occurring During the Study Period.	The time between the completion of the operation and hospital discharge or 14 days post operative if the hospitalzation is prolonged	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.

Secondary Outcome Measures