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

Atrial Fibrillation Clinical Trial

Official title:

A Multicentered, Randomized, Open-Label, Pragmatic Use Study Comparing Vernakalant Therapy to Amiodarone Therapy in Acute Management of Recent Onset Atrial Fibrillation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01627106
• Other study ID #: 6621-055
• Status: Withdrawn
• Phase: Phase 4
• First received: June 21, 2012
• Last updated: August 23, 2013
• Start date: September 2012
• Est. completion date: March 2016

Study information

• Verified date: August 2013
• Source: Cardiome Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.
• Amiodarone
Administered IV as per product label

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cardiome Pharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of participants admitted to hospital directly from the ER after randomization		Day 1 (time of ramdomization)	No