Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery
Information source: William Beaumont Hospitals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart; Dysfunction Postoperative, Cardiac Surgery
Intervention: Atrial fibrillation (Other); Atrial fibrillation (Other)
Phase: N/A
Status: Recruiting
Sponsored by: William Beaumont Hospitals Official(s) and/or principal investigator(s):
Ilana Kutinsky, DO, Principal Investigator, Affiliation: William Beaumont Hospitals
Overall contact:
Patti Naismith, RN, Phone: 248-898-8141, Email: pnaismith@beaumonthospitals.com
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
Clinical Details
Official title: Suppression Of Atrial Fibrillation With Ranolazine After 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
Primary outcome: Freedom from any episode of post operative atrial fibrillation longer than 6 hours duration occurring during the study period.
Secondary outcome: Telemetry monitoring strips
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
Minimum age: 22 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Patti Naismith, RN, Phone: 248-898-8141, Email: pnaismith@beaumonthospitals.com
William Beaumont Hospital, Royal Oak, Michigan 48073, United States; Recruiting
Patti Naismith, RN, Phone: 248-898-8141, Email: pnaismith@beaumonthospitals.com
Ilana Kutinsky, DO, Principal Investigator
William Beaumont Hospital, Troy, Michigan 48085-1198, United States; Recruiting
Coleen Tessmar, RN, Phone: 248-964-8524, Email: ctessmar@beaumonthospital.edu
Ilana Kutinsky, DO, Principal Investigator
Additional Information
Starting date: September 2010
Last updated: July 24, 2012
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