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

• Status: Terminated
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwell Health
• Collaborator: Gilead Sciences
• Treatments: Ranolazine

Criteria

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