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

Not Applicable

Terminated

• Conditions: Atrial Fibrillation New Onset; Ventricular Tachycardia; Medical Care; Complications, Late Effect of Complications; Hemorrhage; Prolonged QTc Interval
• Interventions: Drug: Placebo; Drug: Ranolazine

• Registration Number: NCT01590979
• Lead Sponsor: Northwell Health

Brief 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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-27
• Study First Submitted QC: 2012-05-01
• Study First Posted: 2012-05-03
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Results First Submitted: 2016-09-08
• Status Verified: 2017-02
• Results First Submitted QC: 2017-02-01
• Last Update Submitted: 2017-02-01
• Results First Posted: 2017-03-23
• Last Update Posted: 2017-03-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)
Ranolazine	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.

Primary Outcome Measures

Name	Time	Method
Incidence of New Onset Atrial Fibrillation Rate in Post-Operative Cardiac Surgery Patients	3 weeks after surgery

Trial Locations

Locations (1)

Staten Island University Hosptial; 🇺🇸 Staten Island, New York, United States