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This study has been withdrawn prior to enrollment.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
  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:


Further study details as provided by Cardiome Pharma:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Cardiome Pharma
ClinicalTrials.gov Identifier: NCT01627106     History of Changes
Other Study ID Numbers: 6621-055
Study First Received: June 21, 2012
Last Updated: August 23, 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 August 21, 2014