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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01627106
First received: June 21, 2012
Last updated: February 20, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Atrial Fibrillation
 Drug: Vernakalant
Drug: Amiodarone
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants admitted to hospital directly from the ER after randomization [ Time Frame: Day 1 (time of ramdomization) ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01627106     History of Changes
Other Study ID Numbers: 6621-055
Study First Received: June 21, 2012
Last Updated: February 20, 2013
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on June 18, 2013