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This study has been withdrawn prior to enrollment.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):
Cardiome Pharma
ClinicalTrials.gov Identifier:
NCT01627106
First received: June 21, 2012
Last updated: August 23, 2013
Last verified: August 2013

June 21, 2012
August 23, 2013
September 2012
February 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01627106 on ClinicalTrials.gov Archive Site
Number of participants admitted to hospital directly from the ER after randomization [ Time Frame: Day 1 (time of ramdomization) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study Comparing Vernakalant Therapy to Amiodarone Therapy in Acute Management of Recent Onset Atrial Fibrillation (AF) (MK-6621-055)
A Multicentered, Randomized, Open-Label, Pragmatic Use Study Comparing Vernakalant Therapy to Amiodarone Therapy in Acute Management of Recent Onset Atrial Fibrillation

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Fibrillation
  • 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
  • Drug: Amiodarone
    Administered IV as per product label
    Other Names:
    • Pacerone
    • Cordarone
  • Experimental: Vernakalant
    Intervention: Drug: Vernakalant
  • Active Comparator: Amiodarone
    Intervention: Drug: Amiodarone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2016
February 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01627106
6621-055
Yes
Cardiome Pharma
Cardiome Pharma
Not Provided
Not Provided
Cardiome Pharma
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP