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

NCT01590979 | Terminated Results DMC

• 1 other identifier: Bekheit-Ranolazine
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Atrial Fibrillation New Onset; Ranolazine; CABG; valve repair/replacement; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of New Onset Atrial Fibrillation Rate in Post-Operative Cardiac Surgery Patients

  3 weeks after surgery

Study Arms (2)

Ranolazine

ACTIVE COMPARATOR

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.

Drug: Ranolazine

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Ranolazine DRUG

1000mg, two times a day, 12 hour intervals

Also known as: RANEXA®

Ranolazine

Placebo DRUG

two times a day, 12 hour intervals

Also known as: Sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• Gilead Sciences: collaborator

Study Sites (1)

Staten Island University Hosptial

Staten Island, New York, 10305, United States

Location

Related Links

• The conversion of paroxysmal or initial onset atrial fibrillation with oral Ranolazine: Implications for a new "pill-in-pocket" approach in structural heart disease.
• 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.

MeSH Terms

Conditions

Hemorrhage; Tachycardia, Ventricular

Interventions

Ranolazine; Sugars

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates

Limitations and Caveats

Due to insufficient accrual rate the study was stopped before the recruitment total was met. Thus, a major limitation is small sample size.

Results Point of Contact

• Title: Soad Bekheit, MD
• Organization: Staten Island University Hospital, Northwell Health

msills@northwell.edu

718-226-6629

Study Officials

• Soad Bekheit, MD

  Staten Island University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Electrophysiology Lab

Study Record Dates

• First Submitted: April 27, 2012
• First Posted: May 3, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 23, 2017
• Results First Posted: March 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)