Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation
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|ClinicalTrials.gov Identifier: NCT01590979|
Recruitment Status : Terminated (The study was terminated due to slow rate of accrual resulting in a sample size.)
First Posted : May 3, 2012
Results First Posted : March 23, 2017
Last Update Posted : March 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation New Onset Hemorrhage Prolonged QTc Interval Ventricular Tachycardia Medical Care; Complications, Late Effect of Complications||Drug: Ranolazine Drug: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation Rates in Post-Operative Cardiac Surgery Patients|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Active Comparator: Ranolazine
The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias.
1000mg, two times a day, 12 hour intervals
Other Name: RANEXA®
Placebo Comparator: Placebo
Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)
two times a day, 12 hour intervals
Other Name: Sugar pill
- Incidence of New Onset Atrial Fibrillation Rate in Post-Operative Cardiac Surgery Patients [ Time Frame: 3 weeks after surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01590979
|United States, New York|
|Staten Island University Hosptial|
|Staten Island, New York, United States, 10305|
|Principal Investigator:||Soad Bekheit, MD||Staten Island University Hospital|