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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by North Shore Long Island Jewish Health System
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: September 29, 2014
Last verified: September 2014

April 27, 2012
September 29, 2014
April 2012
March 2015   (final data collection date for primary outcome measure)
Incidence of new onset Atrial fibrillation rate in Post-Operative Cardiac Surgery patients [ Time Frame: 3 weeks after surgery ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01590979 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Atrial Fibrillation New Onset
  • Hemorrhage
  • Prolonged QTc Interval
  • Ventricular Tachycardia
  • Medical Care; Complications, Late Effect of Complications
  • Drug: Ranolazine
    1000mg, two times a day, 12 hour intervals
    Other Name: RANEXA®
  • Drug: Placebo
    two times a day, 12 hour intervals
    Other Name: Sugar pill
  • 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.
    Intervention: Drug: Ranolazine
  • Placebo Comparator: Placebo
    Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
266
June 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Mustafain Meghani, MD 718-226-9000 mustafain@hotmail.com
Contact: Soad Bekheit, MD 718-226-9000 sbekheit@siuh.edu
United States
 
NCT01590979
Bekheit-Ranolazine
Yes
Soad Bekheit, Staten Island University Hospital
North Shore Long Island Jewish Health System
Gilead Sciences
Principal Investigator: Soad Bekheit, MD Staten Island University Hospital
North Shore Long Island Jewish Health System
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP