Safety and Efficacy of Vanoxerine for Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm (COR-ART)

Laguna Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Atrial Flutter; Symptomatic Atrial Fibrillation

Treatments: Drug: Placebo; Drug: Vanoxerine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01691313

CRX-VN-002

Details and patient eligibility

About

Evaluate the safety and efficacy of a single oral dose of vanoxerine compared to placebo, in a dose modification manner, on the conversion of symptomatic atrial fibrillation (a-fib) or flutter of recent onset to normal sinus rhythm.

Full description

Vanoxerine has important antiarrhythmic properties and may prove effective in converting AF/AFL to sinus rhythm in subjects with a history of AF. This is a prospective, randomized, double-blinded, placebo-controlled, dose-modifying study in subjects who have been in symptomatic AF or AFL for more than 3 hours and less than 7 days as dated by symptoms, who have AF/AFL documented on ECG at the time of study drug administration, and who satisfy the inclusion and exclusion criteria. The primary objectives of the trial are to evaluate the safety and efficacy of a single oral dose of vanoxerine compared to placebo following oral administration.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• provide written informed consent,
• male or female 18 years of age or greater; women of child bearing potential must use adequate contraception
• symptomatic AF/AFL for more than 3 hours and less than 7 days (168 hours), as dated by symptoms
• AF/AFL documented by ECG at the start of study drug administration

Exclusion criteria

• Systolic blood pressure <100 mmHg.
• Average heart rate <50 bpm.
• Average QTcF (Fridericia correction) >440 ms.
• Average QRS interval >140 ms.
• Paced atrial or ventricular rhythm on ECG.
• Serum potassium <3.5 meq/L (may be corrected prior to randomization).
• Received another intravenous Class I or Class III antiarrhythmic drug within prior 3 days.
• received amiodarone (oral or IV) in prior 3 months.
• Clinical evidence or history of acute coronary syndrome within 30 days prior to randomization.
• Aortic stenosis with aortic valve area equal to or less than 1.0 cm2.
• Rheumatic mitral stenosis with valve area of <1.5 cm2.
• Untreated hyperthyroidism.
• Acute pericarditis.
• AF/AFL as a result of surgery within the last 7 days
• History of failed electrical cardioversion
• History of polymorphic ventricular tachycardia (PVT, e.g. torsades de pointes).
• History or family history of long QT syndrome.
• History of ventricular tachycardia requiring drug or device therapy.
• History of NYHA Heart Failure Class 3 or 4 or recent (within 1 month) onset of heart failure not related to rapid ventricular response AF.
• Ejection fraction (EF) of 35% or less.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 4 patient groups, including a placebo group

vanoxerine 200mg

Experimental group

Description:

vanoxerine HCl 200mg single dose (2x 100 mg oral capsule)

Treatment:

Drug: Vanoxerine

placebo

Placebo Comparator group

Description:

placebo to match vanoxerine oral capsule

Treatment:

Drug: Placebo

vanoxerine 300mg

Experimental group

Description:

vanoxerine HCl 300 mg single dose (3x 100mg oral capsules)

Treatment:

Drug: Vanoxerine

vanoxerine 400mg

Experimental group

Description:

vanoxerine HCl 400 mg single dose (4x 100 mg oral capsules)

Treatment:

Drug: Vanoxerine