A Study of the Efficacy and Safety of Vernakalant Hydrochloride (MK-6621) in Patients With Atrial Fibrillation (MK-6621-010 AM4)

Study Overview
=================
Brief Summary
-----------------
This study will investigate if treatment with vernakalant hydrochloride (MK-6621) results in a greater proportion of patients with treatment-induced conversion of Atrial Fibrillation to sinus rhythm compared to placebo.

Detailed Description
-----------------
Amendment 4 of the protocol revised the planned enrollment to 123 participants and removed China as one of the countries participating in the study.

Official Title
-----------------
A Phase III, Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of MK-6621 in Patients With Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: vernakalant hydrochloride
* Drug: Placebo to vernakalent hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Abstinent or willing to use 2 acceptable methods of birth control Patient has an atrial arrhythmia with dysrhythmic symptoms Patient is receiving adequate anticoagulant therapy Patient has stable blood pressure Patient weighs between 45 and 136 kg (99 and 300 lbs) Patient is adequately hydrated Exclusion Criteria: Patient is pregnant, breast-feeding, or expecting to become pregnant during the study Patient routinely consumes more than 2 alcoholic drinks per day Patient has known or suspected prolonged QT, familial long QT syndrome, previous Torsades de Pointes, Brugada syndrome Patient has known bradycardia, advanced AV block, or sick-sinus syndrome, unless controlled by a pacemaker Patient has severe aortic stenosis Patient has atrial flutter Patient has Class IV congestive heart failure (CHF) Patient has had a myocardial infarction (MI) or acute coronary syndrome (ACS) Patient has had cardiac surgery within 30 days Patient has known atrial thrombus Patient has reversible causes of Atrial Fibrillation Patient has failed electrical cardioversion during current episode of Atrial Fibrillation Patient has uncorrected electrolyte imbalance Patient has clinical evidence of digoxin toxicity Patient has received certain antiarrhythmic drugs or intravenous amiodarone within 7 days Patient is known to be HIV positive Patient has a history of cancer within the past 5 years, except for certain skin or cervical cancers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vernakalant HCl<br>vernakalant hydrochloride | Drug: vernakalant hydrochloride<br>* Patients will receive a 3 mg/kg infusion of vernakalant hydrochloride. If the patient is in atrial fibrillation (AF) or atrial flutter (AFL) 25 minutes after the start of the infusion, then a second infusion of 2 mg/kg vernakalant hydrochloride will be administered.<br>* Other names: MK-6621;|
| Placebo Comparator: placebo<br>placebo | Drug: Placebo to vernakalent hydrochloride<br>* Patients will receive an infusion of placebo. If the patient is in atrial fibrillation (AF) or atrial flutter (AFL) 25 minutes after the start of the infusion, then a second infusion of placebo will be administered.<br>* Other names: Saline;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients With Treatment-induced Conversion of Atrial Fibrillation to Sinus Rhythm | The proportion of patients with treatment-induced conversion of atrial fibrillation to sinus rhythm for a minimum duration of 1 minute | Within 90 minutes after first exposure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Fibrillation