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

NCT01627106 | Withdrawn Phase 4 DMC

• 1 other identifier: 6621-055
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants admitted to hospital directly from the ER after randomization

  Day 1 (time of ramdomization)

Study Arms (2)

Vernakalant

EXPERIMENTAL

Drug: Vernakalant

Amiodarone

ACTIVE COMPARATOR

Drug: Amiodarone

Interventions

Vernakalant DRUG

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.

Also known as: Brinavess

Vernakalant

Amiodarone DRUG

Administered IV as per product label

Also known as: Pacerone, Cordarone

Amiodarone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Advanz Pharma: lead

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

vernakalant; Amiodarone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2012
• First Posted: June 25, 2012
• Study Start: September 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 26, 2013

Record last verified: 2013-08