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

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ClinicalTrials.gov Identifier: NCT01590979
Recruitment Status : Terminated (The study was terminated due to slow rate of accrual resulting in a sample size.)
First Posted : May 3, 2012
Results First Posted : March 23, 2017
Last Update Posted : March 23, 2017
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Soad Bekheit, Northwell Health

Tracking Information
First Submitted Date  ICMJE April 27, 2012
First Posted Date  ICMJE May 3, 2012
Results First Submitted Date  ICMJE September 8, 2016
Results First Posted Date  ICMJE March 23, 2017
Last Update Posted Date March 23, 2017
Study Start Date  ICMJE April 2012
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2012)
Incidence of New Onset Atrial Fibrillation Rate in Post-Operative Cardiac Surgery Patients [ Time Frame: 3 weeks after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01590979 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation
Official Title  ICMJE Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation Rates in Post-Operative Cardiac Surgery Patients
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Atrial Fibrillation New Onset
  • Hemorrhage
  • Prolonged QTc Interval
  • Ventricular Tachycardia
  • Medical Care; Complications, Late Effect of Complications
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 18, 2015)
54
Original Estimated Enrollment  ICMJE
 (submitted: May 1, 2012)
266
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01590979
Other Study ID Numbers  ICMJE Bekheit-Ranolazine
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Soad Bekheit, Northwell Health
Study Sponsor  ICMJE Northwell Health
Collaborators  ICMJE Gilead Sciences
Investigators  ICMJE
Principal Investigator: Soad Bekheit, MD Staten Island University Hospital
PRS Account Northwell Health
Verification Date February 2017

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