Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation
| Status: | Completed |
|---|---|
| Conditions: | Atrial Fibrillation, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2012 |
| End Date: | June 2015 |
Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation Rates in Post-Operative Cardiac Surgery Patients
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 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.
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.
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
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