Atrial Fibrillation New Onset, Hemorrhage, Medical Care; Complications, Late Effect of Complications, Prolonged QTc Interval, Ventricular Tachycardia
Conditions
Keywords
Atrial Fibrillation New Onset, Ranolazine, CABG, valve repair/replacement, Cardiac Surgery
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.
Interventions
DRUGRanolazine
1000mg, two times a day, 12 hour intervals
DRUGPlacebo
two times a day, 12 hour intervals
Sponsors
Gilead Sciences
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of New Onset Atrial Fibrillation Rate in Post-Operative Cardiac Surgery Patients | 3 weeks after surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Ranolazine: 1000mg, two times a day, 12 hour intervals | 27 |
| Placebo Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)
Placebo: two times a day, 12 hour intervals | 27 |
| Total | 54 |
Baseline characteristics
| Characteristic | Total | Ranolazine | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 30 Participants | 15 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 12 Participants | 12 Participants |
| Age, Continuous | 64.3 years STANDARD_DEVIATION 11 | 65.7 years STANDARD_DEVIATION 11.7 | 62.9 years STANDARD_DEVIATION 11.1 |
| Region of Enrollment United States | 54 participants | 27 participants | 27 participants |
| Sex: Female, Male Female | 11 Participants | 5 Participants | 6 Participants |
| Sex: Female, Male Male | 43 Participants | 22 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 27 | 3 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 |
Outcome results
Primary
Incidence of New Onset Atrial Fibrillation Rate in Post-Operative Cardiac Surgery Patients
Time frame: 3 weeks after surgery
Population: Fifty-four patients were randomized with a mean follow-up of 25 months and none were lost to follow-up. The study was terminated due to slow rate of accrual resulting in a sample size of 27 ranolazine and 27 placebo.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ranolazine | Incidence of New Onset Atrial Fibrillation Rate in Post-Operative Cardiac Surgery Patients | 5 Participants |
| Placebo | Incidence of New Onset Atrial Fibrillation Rate in Post-Operative Cardiac Surgery Patients | 8 Participants |