A Study of the Efficacy and Safety of Vernakalant Hydrochloride (MK-6621) in Patients With Atrial Fibrillation (MK-6621-010 AM4)
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: vernakalant hydrochloride; Placebo to vernakalent hydrochloride
Intervention description: 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.; 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Atrial Fibrillation

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.
    

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