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

Advanz Pharma

Status and phase

Withdrawn

Phase 4

Conditions

Atrial Fibrillation

Treatments

Drug: Amiodarone

Drug: Vernakalant

Study type

Interventional

Funder types

Industry

Identifiers

6621-055

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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