A Study Comparing Vernakalant Therapy to Amiodarone Therapy in Acute Management of Recent Onset Atrial Fibrillation (AF) (MK-6621-055)

A Multicentered, Randomized, Open-Label, Pragmatic Use Study Comparing Vernakalant Therapy to Amiodarone Therapy in Acute Management of Recent Onset Atrial Fibrillation

This study will compare vernakalant therapy to amiodarone therapy in the acute management of recent onset atrial fibrillation.

Study Overview

• Status: Withdrawn
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Vernakalant; Drug: Amiodarone

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Symptomatic AF (duration of current episode is ≤7 days), which is hemodynamically stable, and participant has no other condition at the time of screening that may result in acute hospitalization
• If female and of reproductive potential, the patient agrees to remain abstinent or use 2 acceptable methods of birth control from time of screening until 30-day follow-up.
• Weigh at least 45 kg
• Receiving adequate anticoagulant therapy

Exclusion Criteria:

• Hypersensitivity to the vernakalant or amiodarone or to citric acid, sodium chloride, sodium hydroxide, or iodine
• Severe aortic stenosis
• Systolic blood pressure <100 mmHg
• New York Heart Association (NYHA) Class III or IV heart failure
• Severe bradycardia, sinus node dysfunction, or second and third degree heart block in the absence of a pacemaker
• Use of IV rhythm control anti-arrhythmics (Class I and III) within 4 hours of study drug administration
• Acute coronary syndrome (including myocardial infarction) within previous 30 days
• History of thyroid dysfunction
• Severe acute respiratory failure or cardiovascular collapse
• Participating in another drug study or has received an investigational drug within 30 days prior to enrollment
• Pregnant or breast-feeding, or expecting to conceive from time of screening until 30-day follow-up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vernakalant	Drug: Vernakalant; Initial intravenous (IV) dose of 3 mg/kg (up to a maximum of 339 mg) over 10 minutes, followed by a 15 minute observation period and, if conversion to sinus rhythm does not occur within 15 minutes of the initial infusion, a second 10 minute infusion of vernakalant at a dose of 2 mg/kg (up to a maximum of 226 mg) will be administered.; Other Names: Brinavess
Active Comparator: Amiodarone	Drug: Amiodarone; Administered IV as per product label; Other Names: Cordarone; Pacerone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants discharged from the emergency room (ER) to home, home-equivalent, or long-term care facility (LTCF) within 12 hours from randomization	Up to 12 hours from randomization

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants admitted to hospital directly from the ER after randomization	Day 1 (time of ramdomization)

Collaborators and Investigators

• Sponsor: Advanz Pharma

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): February 1, 2016
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: June 21, 2012
• First Submitted That Met QC Criteria: June 21, 2012
• First Posted (Estimate): June 25, 2012

Study Record Updates

• Last Update Posted (Estimate): August 26, 2013
• Last Update Submitted That Met QC Criteria: August 23, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Enzyme Inhibitors; Membrane Transport Modulators; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Sodium Channel Blockers; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Potassium Channel Blockers; Amiodarone
• Other Study ID Numbers: 6621-055