Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery

This study is currently recruiting participants.
Verified July 2012 by William Beaumont Hospitals
Sponsor:
Collaborators:
Beaumont Foundation of America
Gilead Sciences
Information provided by (Responsible Party):
Ilana Kutinsky, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01352416
First received: May 4, 2011
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

The objective of this study is to show that ranolazine is a safe, viable and potent alternative for post-operative atrial fibrillation suppression in patients undergoing cardiac surgery


Condition Intervention
Heart; Dysfunction Postoperative, Cardiac Surgery
Other: Atrial fibrillation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • Freedom from any episode of post operative atrial fibrillation longer than 6 hours duration occurring during the study period. [ Time Frame: The time between the completion of the operation and hospital discharge or 14 days post operative if the hospitalzation is prolonged ] [ Designated as safety issue: No ]
    To document post operative atrial fibrillation


Secondary Outcome Measures:
  • Telemetry monitoring strips [ Time Frame: paients will be followed for the duration of the hospital stay. An expected average 7 days. ] [ Designated as safety issue: No ]
    Suspected atrial fibrillation will be documented by onset, offset, rate and duration of atrial fibrillation episodes will be recorded as well as cumulative duration of atrial fibrillation episodes


Estimated Enrollment: 240
Study Start Date: September 2010
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ranolazine
1000 mg twice daily. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg twice daily.
Other: Atrial fibrillation
Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses
Placebo Comparator: sugar pill
1000 mg twice daily. If intolerant to the study drug due to adverse effects, or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg twice daily.
Other: Atrial fibrillation
Once the patient goes into atrial fibrillation, the study drug is still continued. Patient will also be treated with standard drug therapy that their doctor chooses

Detailed Description:

A single center, double blind, prospective, randomized study for patients who are scheduled for elective cardiac surgery (CABG, or valve or CABG and valve). All patients who meet criteria will be prospectively enrolled in a randomized fashion. Patients enrolled will be assigned to receive twice daily identical capsules containing either placebo or ranolazine. Study drug will be initiated 2 days before surgery. Patients will receive study drug throughout their hospitalization and be kept on it for a full 2 weeks post operatively. Patients will be seen in 2 weeks and receive a 30 day follow up contact visit.

  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Indications for cardiac surgery (CABG, valve surgery or CABG and valve surgery, Able to provide informed consent.

Exclusion Criteria:

  • Documented atrial fibrillation within the previous 3 months
  • Ongoing therapy with suppressive antiarrhythmic drugs
  • Patient currently on digoxin
  • Emergent surgery
  • Patient receiving hemodialysis
  • Concomitant use of ketoconazole, diltiazem, verapamil
  • Known tolerance or hypersensitivity to ranolazine
  • Pregnant individuals
  • MAZE procedure performed during concurrent cardiac surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01352416

Contacts
Contact: Patti Naismith, RN 248-898-8141 pnaismith@beaumonthospitals.com

Locations
United States, Michigan
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Patti Naismith, RN    248-898-8141    pnaismith@beaumonthospitals.com   
Principal Investigator: Ilana Kutinsky, DO         
William Beaumont Hospital Recruiting
Troy, Michigan, United States, 48085-1198
Contact: Coleen Tessmar, RN    248-964-8524    ctessmar@beaumonthospital.edu   
Principal Investigator: Ilana Kutinsky, DO         
Sponsors and Collaborators
William Beaumont Hospitals
Beaumont Foundation of America
Gilead Sciences
Investigators
Principal Investigator: Ilana Kutinsky, DO William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: Ilana Kutinsky, Physician, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01352416     History of Changes
Other Study ID Numbers: 2009-101, IN-US-259-0114
Study First Received: May 4, 2011
Last Updated: July 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
Suppress Atrial Fibrillation
heart bypass surgery
heart valve surgery

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

ClinicalTrials.gov processed this record on April 22, 2014