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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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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

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Atrial Fibrillation New Onset Hemorrhage Prolonged QTc Interval Ventricular Tachycardia Medical Care; Complications, Late Effect of Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Ranolazine

Intervention Type DRUG

1000mg, two times a day, 12 hour intervals

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

two times a day, 12 hour intervals

Interventions

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Ranolazine

1000mg, two times a day, 12 hour intervals

Intervention Type DRUG

Placebo

two times a day, 12 hour intervals

Intervention Type DRUG

Other Intervention Names

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RANEXA® Sugar pill

Eligibility Criteria

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Inclusion Criteria

* Male and female candidates (18 years of age and older) undergoing coronary bypass grafting surgery or valve repair or replacement - Aortic or Tricuspid or Pulmonary valves
* Patients who are not previously on Ranolazine
* Do not have a history of arrhythmia and are not on any antiarrhythmic therapy
* Patients with QTc on a 12 lead EKG of less than or equal to 460 ms
* Patients with estimated Glomerular Filtration Rate (GFR) greater than 30 mL/min/1.73 m2 on the initial lab work
* Available at least 48 hours before surgery

Exclusion Criteria

* Patients who are not undergoing above surgeries
* Patients undergoing surgery for mitral valve replacement/repair
* Patient with cirrhosis
* Pregnant patients
* Patients with chronic atrial fibrillation
* Patients who had prior adverse drug reactions or allergies to Ranolazine
* Patients who are already taking Ranolazine prior to the study
* Patient who are reported HIV Positive (as there are antiretroviral drug interactions)
* Patients who are on drugs listed in Appendix A prior to the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No