Safety and Efficacy of Vanoxerine for the Conversion of Subjects With Recent Onset Atrial Fibrillation or Flutter to Normal Sinus Rhythm
Condition: Atrial Fibrillation or Flutter
MeSH terms: Atrial Fibrillation
Intervention: Vanoxerine HCl; Placebo
Intervention MeSH terms: Vanoxerine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      LGN-VN-003 is a prospective, multi-center, randomized, double-blind, placebo-controlled study
      to evaluate the safety and efficacy of a single oral dose of vanoxerine for the conversion of
      subjects with recent onset atrial fibrillation (AF) or atrial flutter (AFL) to normal sinus
      rhythm. Up to 625 subjects will be randomized in a 2:1 fashion so at least 400 vanoxerine and
      200 placebo subjects receive study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has been informed of the investigational nature of this study and has given
             written informed consent in accordance with institutional, local, and national
             guidelines.

          -  Able to return for Day 8 follow up.

          -  Male or female 18 years of age or greater.

          -  Onset of AF/AFL within the 7 calendar days preceding randomization, based on symptoms.

          -  AF/AFL documented by ECG during the screening period.

          -  Adherence to local clinical standards or the ACC/AHA or ESC practice guidelines for
             AF/AFL regarding thromboembolic event prevention and treatment.

        Exclusion Criteria:

          -  Previous exposure to vanoxerine HCl.

          -  Women of childbearing potential (neither surgically sterilized nor post-menopausal
             defined as cessation of menses for over one year)

          -  Systolic blood pressure <110 mmHg (unless documented to be usual value).

          -  Average heart rate <60 bpm documented by screening ECG.

          -  Average QTc >440 msec documented by screening ECG.

          -  QRS interval >140 msec documented by screening ECG.

          -  Paced atrial rhythm on screening ECG.

          -  History of receiving another Class I or Class III antiarrhythmic drug within 3 days
             prior to randomization. Excluded Class I antiarrhythmic drugs include quinidine,
             procainamide, disopyramide, lignocaine, mexilitine, flecainide, and propafenone.
             Excluded Class III drugs include dofetilide, sotalol, dronedarone, and ranolazine.

          -  History of amiodarone (oral or IV) within the 90 days prior to randomization.

          -  Native or prosthetic aortic or mitral stenosis with aortic valve area ≤1.0 cm2 or
             mitral valve area of <1.5 cm2 or any other valvular diseases for which surgery is
             indicated.

          -  Treatment with any loop diuretic (e.g., furosemide, bumetanide, torsemide, ethacrynic
             acid, etc.) in the 30 days prior to randomization.

          -  Ejection fraction of <35% within the 3 months prior to randomization (most recent
             measure if more than one).

          -  AF/AFL as a result of surgery (postoperative AF/AFL) within 30 days prior to
             randomization.

          -  History of electrical cardioversion within the 7 calendar days prior to randomization.

          -  History of any polymorphic ventricular tachycardia including torsades de pointes.

          -  History or family history of long QT syndrome or other inherited arrhythmia syndrome.

          -  History of ventricular tachycardia requiring drug or device therapy.