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

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

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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Vernakalant
* Drug: Amiodarone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vernakalant<br> | Drug: Vernakalant<br>* 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.<br>* Other names: Brinavess;|
| Active Comparator: Amiodarone<br> | Drug: Amiodarone<br>* Administered IV as per product label<br>* Other names: Cordarone;|

What is the study measuring?
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Primary Outcome Measures

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