Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation
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Purpose
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.
| Condition | Intervention |
|---|---|
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Atrial Fibrillation New Onset Hemorrhage Prolonged QTc Interval Ventricular Tachycardia Medical Care; Complications, Late Effect of Complications |
Drug: Ranolazine Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation Rates in Post-Operative Cardiac Surgery Patients |
- Incidence of new onset Atrial fibrillation rate in Post-Operative Cardiac Surgery patients [ Time Frame: 3 weeks after surgery ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 266 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
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Drug: Ranolazine
1000mg, two times a day, 12 hour intervals
Other Name: RANEXA®
|
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Placebo Comparator: Placebo
Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)
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Drug: Placebo
two times a day, 12 hour intervals
Other Name: Sugar pill
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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 nitial 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
Contacts and Locations| Contact: Mustafain Meghani, MD | 718-226-9000 | mustafain@hotmail.com |
| Contact: Soad Bekheit, MD | 718-226-9000 | sbekheit@siuh.edu |
| United States, New York | |
| Staten Island University Hosptial | Recruiting |
| Staten Island, New York, United States, 10305 | |
| Contact: Lori Ljutic, RPA, CIM 718-226-6679 lljutic@siuh.edu | |
| Contact: Shannon Marion 718-226-6614 smarion@siuh.edu | |
| Principal Investigator: Soad Bekheit, MD | |
| Sub-Investigator: Mustafain Meghani, MD | |
| Sub-Investigator: Masood A Shariff, MD | |
| Principal Investigator: | Soad Bekheit, MD | Staten Island University Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Soad Bekheit, MD, Director of Electrophysiology Lab, Staten Island University Hospital |
| ClinicalTrials.gov Identifier: | NCT01590979 History of Changes |
| Other Study ID Numbers: | Bekheit-Ranolazine |
| Study First Received: | April 27, 2012 |
| Last Updated: | May 1, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Staten Island University Hospital:
|
Atrial Fibrillation New Onset Ranolazine CABG valve repair/replacement Cardiac Surgery |
Additional relevant MeSH terms:
|
Atrial Fibrillation Hemorrhage Tachycardia Tachycardia, Ventricular Arrhythmias, Cardiac Heart Diseases |
Cardiovascular Diseases Pathologic Processes Ranolazine Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013