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

Phase 4

Withdrawn

• Conditions: Atrial Fibrillation
• Interventions: Drug: Vernakalant; Drug: Amiodarone

• Registration Number: NCT01627106
• Lead Sponsor: Advanz Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-21
• Study First Submitted QC: 2012-06-21
• Study First Posted: 2012-06-25
• Study Start: 2012-09
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-23
• Last Update Posted: 2013-08-26
• Primary Completion: 2016-02
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vernakalant	Vernakalant	-
Amiodarone	Amiodarone	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of participants admitted to hospital directly from the ER after randomization	Day 1 (time of ramdomization)