Atrial Fibrillation
Conditions
Brief summary
This study will compare vernakalant therapy to amiodarone therapy in the acute management of recent onset atrial fibrillation.
Interventions
DRUGVernakalant
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.
DRUGAmiodarone
Administered IV as per product label
Sponsors
Advanz Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| Number of participants admitted to hospital directly from the ER after randomization | Day 1 (time of ramdomization) |
Outcome results
None listed