Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery

Heart; Dysfunction Postoperative, Cardiac Surgery Clinical Trial

Official title:

Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01352416
• Other study ID #: 2009-101, IN-US-259-0114
• Status: Recruiting
• Phase: N/A
• First received: May 4, 2011
• Last updated: July 24, 2012
• Start date: September 2010

Study information

• Verified date: July 2012
• Source: William Beaumont Hospitals
• Contact: Patti Naismith, RN
• Phone: 248-898-8141
• Email: pnaismith[@]beaumonthospitals.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart; Dysfunction Postoperative, Cardiac Surgery

Intervention

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
• 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

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	William Beaumont Hospital	Troy	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
William Beaumont Hospitals	Beaumont Foundation of America, Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from any episode of post operative atrial fibrillation longer than 6 hours duration occurring during the study period.	To document post operative atrial fibrillation	The time between the completion of the operation and hospital discharge or 14 days post operative if the hospitalzation is prolonged	No
Secondary	Telemetry monitoring strips	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	paients will be followed for the duration of the hospital stay. An expected average 7 days.	No