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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Soad Bekheit, Staten Island University Hospital
ClinicalTrials.gov Identifier:
NCT01590979
First received: April 27, 2012
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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 Intervention
Atrial Fibrillation New Onset
Hemorrhage
Prolonged QTc Interval
Ventricular Tachycardia
Medical Care; Complications, Late Effect of Complications
Drug: Ranolazine
Drug: Placebo

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Incidence of new onset Atrial fibrillation rate in Post-Operative Cardiac Surgery patients [ Time Frame: 3 weeks after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 266
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)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01590979

Locations
United States, New York
Staten Island University Hosptial
Staten Island, New York, United States, 10305
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Gilead Sciences
Investigators
Principal Investigator: Soad Bekheit, MD Staten Island University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Soad Bekheit, Director of Electrophysiology Lab, Staten Island University Hospital
ClinicalTrials.gov Identifier: NCT01590979     History of Changes
Other Study ID Numbers: Bekheit-Ranolazine
Study First Received: April 27, 2012
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
Atrial Fibrillation New Onset
Ranolazine
CABG
valve repair/replacement
Cardiac Surgery

Additional relevant MeSH terms:
Atrial Fibrillation
Hemorrhage
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Ranolazine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014