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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Fibrillation, Atrial

Intervention / Treatment
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* Drug: omega-3-acid ethyl esters
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: omega-3-acid ethyl esters<br> | Drug: omega-3-acid ethyl esters<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter | 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. | From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter | 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. | From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24) | 
| Number of Participants With Paroxysmal AF or Persistent AF With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter) | 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. | From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24) | 
| Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter) | 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. | From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24) | 
| Number Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF/Flutter | 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. | From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24) | 
| Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF/Flutter | 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. | From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24) | 
| Number of Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter) | 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. | From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24) | 
| Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter) | 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. | From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24) | 
| Number of Participants With Paroxysmal or Persistent AF With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter | 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. | From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24) | 
| Number of Participants in the Combined AF Subgroups With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter | 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. | From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24) | 
| 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) | 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. | From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24) | 
| 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) | 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. | From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24) | 
| Annualized Number of AF/Flutter Rescue Episodes During the Treatment Period | 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. | From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24) | 
| Annualized Cumulative Frequency of Symptomatic AF/Flutter Recurrences During the Treatment Period | 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. | From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24) | 
| Annualized Cumulative Frequency of Symptomatic AF Recurrences During the Treatment Period | 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. | From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lovaza, Omega-3 fatty acids, Omacor, Paroxysmal atrial fibrillation