Safety and Efficacy of Vanoxerine for Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm

Atrial Flutter Clinical Trial

— COR-ART  

Official title:

Randomized, Double-blind, Placebo-controlled Dose Modification Study to Evaluate the Safety and Efficacy of Single Doses of Vanoxerine for Conversion of Subjects With Recent Onset Atrial Fibrillation or Flutter to Normal Sinus Rhythm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01691313
• Other study ID #: CRX-VN-002
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2012
• Last updated: November 18, 2015
• Start date: November 2012
• Est. completion date: October 2013

Study information

• Verified date: November 2015
• Source: Laguna Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of HealthRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter
• Symptomatic Atrial Fibrillation

Intervention

Drug:
• Vanoxerine
single oral dose
• Placebo
single oral dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laguna Pharmaceuticals, Inc.

Countries where clinical trial is conducted

Israel,  Russian Federation, 

References & Publications (1)

Dittrich HC, Feld GK, Bahnson TD, Camm AJ, Golitsyn S, Katz A, Koontz JI, Kowey PR, Waldo AL, Brown AM. COR-ART: A multicenter, randomized, double-blind, placebo-controlled dose-ranging study to evaluate single oral doses of vanoxerine for conversion of r — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conversion to Sinus Rhythm	proportion of subjects who convert to sinus rhythm through 4 hours after start of study drug	baseline through 4 hours	No
Primary	Conversion to Sinus Rhythm	proportion of subjects who convert to sinus rhythm through 24 hours after start of study drug	baseline through 24 hours	No