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

Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01590979
• Other study ID #: Bekheit-Ranolazine
• Status: Completed
• Phase: N/A
• First received: April 27, 2012
• Last updated: August 18, 2015
• Start date: April 2012
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ranolazine
1000mg, two times a day, 12 hour intervals
• Placebo
two times a day, 12 hour intervals

Locations

Country	Name	City	State
United States	Staten Island University Hosptial	Staten Island	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of new onset Atrial fibrillation rate in Post-Operative Cardiac Surgery patients		3 weeks after surgery	Yes

External Links

•   Comparison of effectiveness and safety of Ranolazine versus amiodarone for preventing atrial fibrillation after coronary artery bypass grafting.
•   Electrophysiologic basis for the antiarrhythmic actions of Ranolazine. Heart Rhythm.
•   The conversion of paroxysmal or initial onset atrial fibrillation with oral Ranolazine: Implications for a new "pill-in-pocket" approach in structural heart disease.