Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation
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 New Onset
Prolonged QTc Interval
Medical Care; Complications, Late Effect of Complications
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation Rates in Post-Operative Cardiac Surgery Patients|
- Incidence of new onset Atrial fibrillation rate in Post-Operative Cardiac Surgery patients [ Time Frame: 3 weeks after surgery ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Active Comparator: 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.
1000mg, two times a day, 12 hour intervals
Other Name: RANEXA®
Placebo Comparator: Placebo
Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)
two times a day, 12 hour intervals
Other Name: Sugar pill
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.
|United States, New York|
|Staten Island University Hosptial|
|Staten Island, New York, United States, 10305|
|Principal Investigator:||Soad Bekheit, MD||Staten Island University Hospital|