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

NCT ID: NCT01627106

Last Updated: 2013-08-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2016-03-31

Brief Summary

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

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vernakalant

Group Type: EXPERIMENTAL

Vernakalant

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

Amiodarone

Intervention Type: DRUG

Administered IV as per product label

Interventions

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.

Intervention Type: DRUG

Amiodarone

Administered IV as per product label

Intervention Type: DRUG

Other Intervention Names

Brinavess; Pacerone; Cordarone

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Advanz Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

6621-055

Identifier Type: -

Identifier Source: org_study_id