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

Primary Purpose

Atrial Fibrillation New Onset, Hemorrhage, Prolonged QTc Interval

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ranolazine
Placebo
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation New Onset focused on measuring Atrial Fibrillation New Onset, Ranolazine, CABG, valve repair/replacement, Cardiac Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Staten Island University Hosptial

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ranolazine

Placebo

Arm Description

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.

Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)

Outcomes

Primary Outcome Measures

Incidence of New Onset Atrial Fibrillation Rate in Post-Operative Cardiac Surgery Patients

Secondary Outcome Measures

Full Information

First Posted
April 27, 2012
Last Updated
February 1, 2017
Sponsor
Northwell Health
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01590979
Brief Title
Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation
Official Title
Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation Rates in Post-Operative Cardiac Surgery Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to slow rate of accrual resulting in a sample size.
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
Collaborators
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation New Onset, Hemorrhage, Prolonged QTc Interval, Ventricular Tachycardia, Medical Care; Complications, Late Effect of Complications
Keywords
Atrial Fibrillation New Onset, Ranolazine, CABG, valve repair/replacement, Cardiac Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ranolazine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)
Intervention Type
Drug
Intervention Name(s)
Ranolazine
Other Intervention Name(s)
RANEXA®
Intervention Description
1000mg, two times a day, 12 hour intervals
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
two times a day, 12 hour intervals
Primary Outcome Measure Information:
Title
Incidence of New Onset Atrial Fibrillation Rate in Post-Operative Cardiac Surgery Patients
Time Frame
3 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soad Bekheit, MD
Organizational Affiliation
Staten Island University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Staten Island University Hosptial
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://preview.ncbi.nlm.nih.gov/pubmed?term=Murdock%20DK%2C%20Kersten%20M%2C%20Kaliebe%20J%2C%20Larrain%20G
Description
The conversion of paroxysmal or initial onset atrial fibrillation with oral Ranolazine: Implications for a new "pill-in-pocket" approach in structural heart disease.
URL
http://preview.ncbi.nlm.nih.gov/pubmed?term=21726841
Description
Comparison of effectiveness and safety of Ranolazine versus amiodarone for preventing atrial fibrillation after coronary artery bypass grafting.
URL
http://preview.ncbi.nlm.nih.gov/pubmed?term=21421082
Description
Electrophysiologic basis for the antiarrhythmic actions of Ranolazine. Heart Rhythm.

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

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