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

• ClinicalTrials.gov Identifier: NCT01590979
• Recruitment Status: Terminated
• First Posted: May 3, 2012
• Results First Posted: March 23, 2017
• Last Update Posted: March 23, 2017
• Sponsor: Northwell Health
• Collaborator: Gilead Sciences
• Information provided by (Responsible Party): Soad Bekheit, Northwell Health

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Atrial Fibrillation New Onset; Hemorrhage; Prolonged QTc Interval; Ventricular Tachycardia; Medical Care; Complications, Late Effect of Complications	Drug: Ranolazine; Drug: Placebo	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, 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
• Study Start Date: April 2012
• Actual Primary Completion Date: June 2015
• Actual Study Completion Date: June 2015

Arms and Interventions

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 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)	Drug: Placebo; two times a day, 12 hour intervals; Other Name: Sugar pill

Outcome Measures

Primary Outcome Measures :

1. Incidence of New Onset Atrial Fibrillation Rate in Post-Operative Cardiac Surgery Patients [ Time Frame: 3 weeks after surgery ]

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, New York

Staten Island University Hosptial

Staten Island, New York, United States, 10305

Sponsors and Collaborators

Northwell Health

Gilead Sciences

Investigators

• Principal Investigator: Soad Bekheit, MD; Staten Island University Hospital

More Information

Additional Information:

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. 

• Responsible Party: Soad Bekheit, Director of Electrophysiology Lab, Northwell Health
• ClinicalTrials.gov Identifier: NCT01590979
• Other Study ID Numbers: Bekheit-Ranolazine
• First Posted: May 3, 2012
• Results First Posted: March 23, 2017
• Last Update Posted: March 23, 2017
• Last Verified: February 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Soad Bekheit, Northwell Health:

Atrial Fibrillation New Onset; Ranolazine; CABG; valve repair/replacement; Cardiac Surgery

Additional relevant MeSH terms:

Atrial Fibrillation; Tachycardia; Tachycardia, Ventricular; Hemorrhage; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Cardiac Conduction System Disease; Ranolazine; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action