Clinical Trials Directory

Trials / Terminated

TerminatedNCT01590979

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

Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation Rates in Post-Operative Cardiac Surgery Patients

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
54 (actual)
Sponsor
Northwell Health · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGRanolazine1000mg, two times a day, 12 hour intervals
DRUGPlacebotwo times a day, 12 hour intervals

Timeline

Start date
2012-04-01
Primary completion
2015-06-01
Completion
2015-06-01
First posted
2012-05-03
Last updated
2017-03-23
Results posted
2017-03-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01590979. Inclusion in this directory is not an endorsement.