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

Primary Purpose

Atrial Fibrillation

Status

Withdrawn

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Vernakalant

Amiodarone

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vernakalant

Amiodarone

Arm Description

Outcomes

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

Secondary Outcome Measures

Number of participants admitted to hospital directly from the ER after randomization

Full Information

NCT ID

NCT01627106

First Posted

June 21, 2012

Last Updated

August 23, 2013

Sponsor

Advanz Pharma

1. Study Identification

Unique Protocol Identification Number

NCT01627106

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Withdrawn

Study Start Date

September 2012 (undefined)

Primary Completion Date

February 2016 (Anticipated)

Study Completion Date

March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Advanz Pharma

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vernakalant

Arm Type

Experimental

Arm Title

Amiodarone

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Vernakalant

Other Intervention Name(s)

Brinavess

Intervention Description

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

Intervention Name(s)

Amiodarone

Other Intervention Name(s)

Pacerone, Cordarone

Intervention Description

Administered IV as per product label

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Number of participants admitted to hospital directly from the ER after randomization

Time Frame

Day 1 (time of ramdomization)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Learn more about this trial

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

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