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

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.

Study Overview

• Status: Terminated
• Conditions: Hemorrhage; Ventricular Tachycardia; Atrial Fibrillation New Onset; Prolonged QTc Interval; Medical Care; Complications, Late Effect of Complications
• Intervention / Treatment: Drug: Ranolazine; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Staten Island, New York, United States, 10305
      • Staten Island University Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Ranolazine; 1000mg, two times a day, 12 hour intervals; Other Names: 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)	Drug: Placebo; two times a day, 12 hour intervals; Other Names: Sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of New Onset Atrial Fibrillation Rate in Post-Operative Cardiac Surgery Patients	3 weeks after surgery

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: Gilead Sciences
• Investigators: Principal Investigator: Soad Bekheit, MD, Staten Island University Hospital

Publications and helpful links

Helpful Links

• The conversion of paroxysmal or initial onset atrial fibrillation with oral Ranolazine: Implications for a new "pill-in-pocket" approach in structural heart disease.
• Comparison of effectiveness and safety of Ranolazine versus amiodarone for preventing atrial fibrillation after coronary artery bypass grafting.
• Electrophysiologic basis for the antiarrhythmic actions of Ranolazine. Heart Rhythm.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: April 27, 2012
• First Submitted That Met QC Criteria: May 1, 2012
• First Posted (Estimate): May 3, 2012

Study Record Updates

• Last Update Posted (Actual): March 23, 2017
• Last Update Submitted That Met QC Criteria: February 1, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: CABG; Cardiac Surgery; Atrial Fibrillation New Onset; Ranolazine; valve repair/replacement
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Atrial Fibrillation; Hemorrhage; Tachycardia; Tachycardia, Ventricular; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Sodium Channel Blockers; Ranolazine
• Other Study ID Numbers: Bekheit-Ranolazine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No