Evaluation of Efficacy and Safety of Lovaza (Omega-3-Acid Ethyl Esters) in Recurrent, Symptomatic Atrial Fibrillation

Overview

The purpose of this study is to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) in patients with recurrent, symptomatic atrial fibrillation.

Full Title of Study: “A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess the Efficacy and Safety of Lovaza for the Prevention of Recurrent, Symptomatic Atrial Fibrillation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 2010

Interventions

  • Drug: omega-3-acid ethyl esters
  • Drug: Placebo

Arms, Groups and Cohorts

  • Experimental: omega-3-acid ethyl esters
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter
    • Time Frame: From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)
    • A documented episode of symptomatic AF /Flutter was defined as AF/Flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. The occurrence of symptomatic atrial flutter was treated as an occurrence of symptomatic AF for this outcome measure. “Censored” in the table below refers to participants who did not have a documented episode of symptomatic AF or flutter.

Secondary Measures

  • Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter
    • Time Frame: From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)
    • A documented episode of symptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. The occurrence of symptomatic atrial flutter was treated as an occurrence of symptomatic AF for this outcome measure. “Censored” in the table below refers to participants who did not have a documented episode of symptomatic AF or flutter.
  • Number of Participants With Paroxysmal AF or Persistent AF With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter)
    • Time Frame: From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24)
    • A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. “Censored” in the table below refers to participants who did not have a documented episode of symptomatic AF.
  • Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter)
    • Time Frame: From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24)
    • A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. “Censored” in the table below refers to participants who did not have a documented episode of symptomatic AF.
  • Number Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF/Flutter
    • Time Frame: From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24)
    • A documented episode of symptomatic or asymptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF or flutter were recorded by TTM during routine bi-weekly transmissions. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. “Censored” in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter.
  • Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF/Flutter
    • Time Frame: From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24)
    • A documented episode of symptomatic or asymptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF or flutter were recorded by TTM during routine bi-weekly transmissions. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. “Censored” in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter.
  • Number of Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter)
    • Time Frame: From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24)
    • A documented episode of symptomatic or asymptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF were recorded by TTM during routine bi-weekly transmissions. “Censored” in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter.
  • Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter)
    • Time Frame: From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24)
    • A documented episode of symptomatic or asymptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF were recorded by TTM during routine bi-weekly transmissions. “Censored” in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter.
  • Number of Participants With Paroxysmal or Persistent AF With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter
    • Time Frame: From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24)
    • A documented episode of symptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. “Censored” in the table below refers to participants who did not have a documented episode of symptomatic AF/flutter.
  • Number of Participants in the Combined AF Subgroups With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter
    • Time Frame: From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24)
    • A documented episode of symptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. “Censored” in the table below refers to participants who did not have a documented episode of symptomatic AF/flutter.
  • Number of Participants With Paroxysmal or Persistent AF With an Event That Occurred After Completion of Day 7 to the Occurrence of Symptomatic AF (Exclusive of Flutter)
    • Time Frame: From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24)
    • A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. “Censored” in the table below refers to participants who did not have a documented episode of symptomatic AF.
  • Number of Participants in the Combined AF Subgroups With an Event That Occurred After Completion of Day 7 to the Occurrence of Symptomatic AF (Exclusive of Flutter)
    • Time Frame: From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24)
    • A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. “Censored” in the table below refers to participants who did not have a documented episode of symptomatic AF.
  • Annualized Number of AF/Flutter Rescue Episodes During the Treatment Period
    • Time Frame: From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)
    • Rescue was defined as any pharmacological/electrical/surgical intervention for the termination/prevention of AF/flutter with a maximum of one rescue episode counted per day. Note: all annualized values were calculated by counting the number of rescue episodes, dividing by the number of days on treatment, then multiplying that number by 365.25.
  • Annualized Cumulative Frequency of Symptomatic AF/Flutter Recurrences During the Treatment Period
    • Time Frame: From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)
    • Values were annualized by counting the number of episodes of symptomatic AF/flutter recurrences (maximum of one per day), dividing by the number of days on treatment, then multiplying this number by 365.25.
  • Annualized Cumulative Frequency of Symptomatic AF Recurrences During the Treatment Period
    • Time Frame: From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)
    • Values were annualized by counting the number of episodes of symptomatic AF recurrences (maximum of one per day), dividing by the number of days on treatment, then multiplying this number by 365.25.

Participating in This Clinical Trial

Inclusion Criteria

  • Men and women age 18 years or older – History of symptomatic atrial fibrillation (either paroxysmal or persistent) – Provide written informed consent and authorization for protected health information disclosure Exclusion Criteria:

  • Permanent (chronic) atrial fibrillation – Antiarrhythmic drug therapy which cannot be stopped – Use of amiodarone with prior 6 months – History of unsuccessful cardioversion – History of certain cardiovascular conditions or cardiac surgery within prior 6 months – History of stroke within prior 6 months – Implanted cardio-defibrillator – Certain circulatory, thyroid, pulmonary, liver, kidney, musculoskeletal or metabolic conditions, or cancer (except non-melanoma skin cancer) – Poorly controlled diabetes

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, GlaxoSmithKline

Citations Reporting on Results

Kowey PR, Reiffel JA, Ellenbogen KA, Naccarelli GV, Pratt CM. Efficacy and safety of prescription omega-3 fatty acids for the prevention of recurrent symptomatic atrial fibrillation: a randomized controlled trial. JAMA. 2010 Dec 1;304(21):2363-72. doi: 10.1001/jama.2010.1735. Epub 2010 Nov 15.

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