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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

Page last updated: August 23, 2015

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