A Phase 3b Study of Vernakalant Injection in Patients With Recent Onset Symptomatic Atrial Fibrillation (AF)(MK-6621-045) "ACT V"

Terminated

Phase 3 Results N/A

Trial Description

The purpose of this study is to evaluate the safety and efficacy of vernakalant injection in subjects with recent onset (AF > 3 hours to <= 7 days), symptomatic atrial fibrillation and no evidence or history of congestive heart failure.

Detailed Description

Participants received a 10-minute intravenous (IV) infusion of vernakalant (3 mg/kg) or an equivalent amount of normal saline (placebo), followed by a 15-minute observation period. If the participant was still in atrial fibrillation or atrial flutter, a second 10-minute IV infusion of vernakalant (2 mg/kg) or an equivalent amount of placebo was administered unless the participant experienced any dose-stopping criteria after the start of the first infusion. If a participant converted to sinus rhythm during the first or second infusion, that infusion was completed.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Injection
    ARM 1: Kind: Experimental
    Label: Placebo
  • Vernakalant hydrochloride Drug
    Intervention Desc: Vernakalant hydrochloride (RSD-1235) is a mixed ion channel blocker with selectivity for atrial ion channels that does not promote ventricular arrhythmia. An i.v. formulation is in development for acute conversion of patients with atrial fibrillation or atrial flutter, and an oral formulation is being developed for the maintenance of sinus rhythm in patients at risk of developing atrial fibrillation.
  • Vernakalant Drug
    Other Names: RSD1235
    Intervention Desc: Maximum volume of 100 mL as per the dosing schedule, administered intravenously (IV) over 10 minutes
    ARM 1: Kind: Experimental
    Label: Vernakalant

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients randomized to either placebo or Vernakalant and observed for conversion of AF to SR within 1 minute after injection. Then observed for occurrences of hypotension, ventricular arrythmias and death occurring within the first two hours after start of study treatment.

Outcomes

Type Measure Time Frame Safety Issue
Primary Composite of occurrences of hypotension, ventricular arrhythmias and death verified by the Clinical Events Committee; successful conversion to sinus rhythm (SR) for at least one minute.
Secondary Time from first exposure to study treatment to conversion of AF to SR; proportion of subjects reporting no symptoms.
Primary Composite of occurrences of hypotension, ventricular arrhythmias and death verified by the Clinical Events Committee Occurring within the first two hours after start of study treatment Yes
Primary Successful conversion to sinus rhythm (SR) for at least one minute Occurring within 90 minutes of first exposure to study treatment No
Secondary Time from first exposure to study treatment to conversion of AF to SR Occurring within 90 minutes after study treatment No
Secondary Proportion of subjects reporting no symptoms Occurring 90 minutes after first exposure to study treatment No
Primary Number of Participants who Experience Hypotension, Ventricular Arrhythmias and/or Death Occurring within the first two hours after start of study treatment Yes
Primary Number of Participant with Successful Conversion to Sinus rhythm (SR) Occurring within 90 minutes of first exposure to study treatment No
Secondary Number of Participants who Report No Symptoms Occurring 90 minutes after first exposure to study treatment No

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