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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01627106
Recruitment Status : Withdrawn
First Posted : June 25, 2012
Last Update Posted : August 26, 2013
Information provided by (Responsible Party):
Cardiome Pharma

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Vernakalant Drug: Amiodarone Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentered, Randomized, Open-Label, Pragmatic Use Study Comparing Vernakalant Therapy to Amiodarone Therapy in Acute Management of Recent Onset Atrial Fibrillation
Study Start Date : September 2012
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Vernakalant Drug: Vernakalant
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.
Other Name: Brinavess

Active Comparator: Amiodarone Drug: Amiodarone
Administered IV as per product label
Other Names:
  • Pacerone
  • Cordarone

Primary Outcome Measures :
  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 [ Time Frame: Up to 12 hours from randomization ]

Secondary Outcome Measures :
  1. Number of participants admitted to hospital directly from the ER after randomization [ Time Frame: Day 1 (time of ramdomization) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Responsible Party: Cardiome Pharma Identifier: NCT01627106     History of Changes
Other Study ID Numbers: 6621-055
First Posted: June 25, 2012    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors