Fibrillation, Atrial
Conditions
Keywords
Lovaza, Omega-3 fatty acids, Omacor, Paroxysmal atrial fibrillation
Brief summary
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.
Interventions
DRUGPlacebo
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Paroxysmal AF or Persistent AF With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter) | 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) | 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 | 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 | 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) | 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) | 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 Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter | 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 in the Combined AF Subgroups With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter | 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) | 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) | 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 | 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 | 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 | 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. |
| Number of Participants With Paroxysmal or Persistent AF With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paroxysmal AF, P-OM3 Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 grams (g) per day for the first 7 days; 4 g per day thereafter through Week 24. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF in the participant's medical record. | 266 |
| Paroxysmal AF, Placebo Participants with paroxysmal AF receiving matching placebo. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record. | 276 |
| Persistent AF, P-OM3 Participants with persistent AF receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record. | 66 |
| Persistent AF, Placebo Participants with persistent AF receiving matching placebo. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record. | 55 |
| Total | 663 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 9 | 14 | 2 | 2 |
| Overall Study | Captured as Other | 6 | 2 | 2 | 2 |
| Overall Study | Lost to Follow-up | 5 | 4 | 0 | 2 |
| Overall Study | Protocol Violation | 3 | 5 | 0 | 3 |
| Overall Study | Withdrew Consent | 10 | 5 | 2 | 1 |
Baseline characteristics
| Characteristic | Paroxysmal AF, P-OM3 | Paroxysmal AF, Placebo | Persistent AF, P-OM3 | Persistent AF, Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 60.0 Years STANDARD_DEVIATION 13.56 | 61.9 Years STANDARD_DEVIATION 11.57 | 58.7 Years STANDARD_DEVIATION 12.65 | 57.6 Years STANDARD_DEVIATION 14.85 | 60.5 Years STANDARD_DEVIATION 12.84 |
| Gender Female | 119 Participants | 138 Participants | 14 Participants | 19 Participants | 290 Participants |
| Gender Male | 147 Participants | 138 Participants | 52 Participants | 36 Participants | 373 Participants |
| Race/Ethnicity, Customized African American | 10 participants | 10 participants | 2 participants | 6 participants | 28 participants |
| Race/Ethnicity, Customized American Indian | 0 participants | 1 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 0 participants | 1 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Hispanic | 9 participants | 9 participants | 1 participants | 3 participants | 22 participants |
| Race/Ethnicity, Customized Unknown | 1 participants | 2 participants | 0 participants | 1 participants | 4 participants |
| Race/Ethnicity, Customized White/Caucasian | 246 participants | 253 participants | 63 participants | 45 participants | 607 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 66 / 331 | 82 / 332 |
| serious Total, serious adverse events | 20 / 331 | 25 / 332 |
Outcome results
Primary
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.
Time frame: From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)
Population: Modified Intent-to-Treat (MITT) Population: all randomized participants who provided at least one post-randomization TTM ECG data transfer or equivalent
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paroxysmal AF, Placebo | Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter | Participants with event | 129 participants |
| Paroxysmal AF, Placebo | Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter | Censored participants | 140 participants |
| Paroxysmal AF, P-OM3 | Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter | Participants with event | 135 participants |
| Paroxysmal AF, P-OM3 | Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter | Censored participants | 123 participants |
p-value: 0.26395% CI: [0.9, 1.46]Regression, Cox
Secondary
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.
Time frame: From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)
Population: MITT Population. The number analyzed represents those participants with an event.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paroxysmal AF, Placebo | Annualized Cumulative Frequency of Symptomatic AF/Flutter Recurrences During the Treatment Period | 6.81 recurrences |
| Paroxysmal AF, P-OM3 | Annualized Cumulative Frequency of Symptomatic AF/Flutter Recurrences During the Treatment Period | 8.32 recurrences |
| Combined, Placebo | Annualized Cumulative Frequency of Symptomatic AF/Flutter Recurrences During the Treatment Period | 4.22 recurrences |
| Combined, P-OM3 | Annualized Cumulative Frequency of Symptomatic AF/Flutter Recurrences During the Treatment Period | 4.35 recurrences |
| Combined, Placebo | Annualized Cumulative Frequency of Symptomatic AF/Flutter Recurrences During the Treatment Period | 6.48 recurrences |
| Combined, P-OM3 | Annualized Cumulative Frequency of Symptomatic AF/Flutter Recurrences During the Treatment Period | 6.52 recurrences |
p-value: 0.21895% CI: [-0.18, 2.21]non-parametric ANCOVA
p-value: 0.18895% CI: [-0.14, 3.14]Wilcoxon (Mann-Whitney)
p-value: 0.09795% CI: [-0.1, 2.1]non-parametric ANCOVA
Secondary
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.
Time frame: From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)
Population: MITT Population. The number analyzed represents those participants with an event.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paroxysmal AF, Placebo | Annualized Cumulative Frequency of Symptomatic AF Recurrences During the Treatment Period | 6.91 recurrences |
| Paroxysmal AF, P-OM3 | Annualized Cumulative Frequency of Symptomatic AF Recurrences During the Treatment Period | 8.30 recurrences |
| Combined, Placebo | Annualized Cumulative Frequency of Symptomatic AF Recurrences During the Treatment Period | 4.22 recurrences |
| Combined, P-OM3 | Annualized Cumulative Frequency of Symptomatic AF Recurrences During the Treatment Period | 4.35 recurrences |
| Combined, Placebo | Annualized Cumulative Frequency of Symptomatic AF Recurrences During the Treatment Period | 6.48 recurrences |
| Combined, P-OM3 | Annualized Cumulative Frequency of Symptomatic AF Recurrences During the Treatment Period | 6.52 recurrences |
p-value: 0.23995% CI: [-0.19, 2.17]non-parametric ANCOVA
p-value: 0.15295% CI: [-0.09, 4.31]Wilcoxon (Mann-Whitney)
p-value: 0.09495% CI: [-0.08, 2.11]non-parametric ANCOVA
Secondary
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.
Time frame: From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)
Population: MITT Population. The number analyzed represents those participants who had a rescue episode.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paroxysmal AF, Placebo | Annualized Number of AF/Flutter Rescue Episodes During the Treatment Period | 2.44 rescue episodes |
| Paroxysmal AF, P-OM3 | Annualized Number of AF/Flutter Rescue Episodes During the Treatment Period | 4.17 rescue episodes |
| Combined, Placebo | Annualized Number of AF/Flutter Rescue Episodes During the Treatment Period | 2.17 rescue episodes |
| Combined, P-OM3 | Annualized Number of AF/Flutter Rescue Episodes During the Treatment Period | 2.24 rescue episodes |
| Combined, Placebo | Annualized Number of AF/Flutter Rescue Episodes During the Treatment Period | 2.19 rescue episodes |
| Combined, P-OM3 | Annualized Number of AF/Flutter Rescue Episodes During the Treatment Period | 4.01 rescue episodes |
p-value: 0.2995% CI: [-0.09, 2.08]non-parametric ANCOVA
p-value: 0.47995% CI: [-0.08, 2.02]Wilcoxon (Mann-Whitney)
p-value: 0.21895% CI: [-0.06, 1.49]non-parametric ANCOVA
Secondary
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.
Time frame: From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24)
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paroxysmal AF, Placebo | Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter) | Participants with event | 144 participants |
| Paroxysmal AF, Placebo | Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter) | Censored participants | 179 participants |
| Paroxysmal AF, P-OM3 | Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter) | Participants with event | 163 participants |
| Paroxysmal AF, P-OM3 | Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter) | Censored participants | 159 participants |
p-value: 0.08295% CI: [0.98, 1.53]Regression, Cox
Secondary
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.
Time frame: From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24)
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paroxysmal AF, Placebo | Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter) | Censored participants | 150 participants |
| Paroxysmal AF, Placebo | Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter) | Participants with event | 173 participants |
| Paroxysmal AF, P-OM3 | Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter) | Censored participants | 133 participants |
| Paroxysmal AF, P-OM3 | Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter) | Participants with event | 189 participants |
p-value: 0.16795% CI: [0.94, 1.42]Regression, Cox
Secondary
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.
Time frame: From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24)
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paroxysmal AF, Placebo | Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF/Flutter | Participants with event | 176 participants |
| Paroxysmal AF, Placebo | Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF/Flutter | Censored participants | 147 participants |
| Paroxysmal AF, P-OM3 | Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF/Flutter | Participants with event | 193 participants |
| Paroxysmal AF, P-OM3 | Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF/Flutter | Censored participants | 129 participants |
p-value: 0.16895% CI: [0.94, 1.42]Regression, Cox
Secondary
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.
Time frame: From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24)
Population: MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paroxysmal AF, Placebo | Number of Participants in the Combined AF Subgroups With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter | Participants with event | 103 participants |
| Paroxysmal AF, Placebo | Number of Participants in the Combined AF Subgroups With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter | Censored participants | 170 participants |
| Paroxysmal AF, P-OM3 | Number of Participants in the Combined AF Subgroups With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter | Censored participants | 148 participants |
| Paroxysmal AF, P-OM3 | Number of Participants in the Combined AF Subgroups With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter | Participants with event | 114 participants |
p-value: 0.18595% CI: [0.92, 1.56]Regression, Cox
Secondary
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.
Time frame: From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24)
Population: MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paroxysmal AF, Placebo | 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) | Participants with event | 101 participants |
| Paroxysmal AF, Placebo | 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) | Censored participants | 173 participants |
| Paroxysmal AF, P-OM3 | 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) | Participants with event | 111 participants |
| Paroxysmal AF, P-OM3 | 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) | Censored participants | 152 participants |
p-value: 0.18895% CI: [0.92, 1.57]Regression, Cox
Secondary
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.
Time frame: From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24)
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paroxysmal AF, Placebo | Number of Participants With Paroxysmal AF or Persistent AF With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter) | Participants with event | 126 participants |
| Paroxysmal AF, Placebo | Number of Participants With Paroxysmal AF or Persistent AF With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter) | Censored participants | 143 participants |
| Paroxysmal AF, P-OM3 | Number of Participants With Paroxysmal AF or Persistent AF With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter) | Censored participants | 125 participants |
| Paroxysmal AF, P-OM3 | Number of Participants With Paroxysmal AF or Persistent AF With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter) | Participants with event | 133 participants |
| Combined, Placebo | Number of Participants With Paroxysmal AF or Persistent AF With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter) | Participants with event | 18 participants |
| Combined, Placebo | Number of Participants With Paroxysmal AF or Persistent AF With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter) | Censored participants | 36 participants |
| Combined, P-OM3 | Number of Participants With Paroxysmal AF or Persistent AF With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter) | Participants with event | 30 participants |
| Combined, P-OM3 | Number of Participants With Paroxysmal AF or Persistent AF With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter) | Censored participants | 34 participants |
p-value: 0.21395% CI: [0.91, 1.49]Regression, Cox
p-value: 0.17195% CI: [0.83, 2.69]Log Rank
Secondary
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.
Time frame: From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24)
Population: MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paroxysmal AF, Placebo | Number of Participants With Paroxysmal or Persistent AF With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter | Participants with event | 88 participants |
| Paroxysmal AF, Placebo | Number of Participants With Paroxysmal or Persistent AF With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter | Censored participants | 136 participants |
| Paroxysmal AF, P-OM3 | Number of Participants With Paroxysmal or Persistent AF With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter | Censored participants | 118 participants |
| Paroxysmal AF, P-OM3 | Number of Participants With Paroxysmal or Persistent AF With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter | Participants with event | 87 participants |
| Combined, Placebo | Number of Participants With Paroxysmal or Persistent AF With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter | Participants with event | 15 participants |
| Combined, Placebo | Number of Participants With Paroxysmal or Persistent AF With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter | Censored participants | 34 participants |
| Combined, P-OM3 | Number of Participants With Paroxysmal or Persistent AF With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter | Participants with event | 27 participants |
| Combined, P-OM3 | Number of Participants With Paroxysmal or Persistent AF With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter | Censored participants | 30 participants |
p-value: 0.56595% CI: [0.81, 1.47]Regression, Cox
p-value: 0.10395% CI: [0.89, 3.15]Log Rank
Secondary
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.
Time frame: From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24)
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paroxysmal AF, Placebo | Number of Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter) | Participants with event | 146 participants |
| Paroxysmal AF, Placebo | Number of Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter) | Censored participants | 123 participants |
| Paroxysmal AF, P-OM3 | Number of Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter) | Censored participants | 107 participants |
| Paroxysmal AF, P-OM3 | Number of Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter) | Participants with event | 151 participants |
| Combined, Placebo | Number of Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter) | Participants with event | 27 participants |
| Combined, Placebo | Number of Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter) | Censored participants | 27 participants |
| Combined, P-OM3 | Number of Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter) | Participants with event | 38 participants |
| Combined, P-OM3 | Number of Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter) | Censored participants | 26 participants |
p-value: 0.2795% CI: [0.9, 1.43]Regression, Cox
p-value: 0.48695% CI: [0.73, 1.95]Log Rank
Secondary
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.
Time frame: From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24)
Population: MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paroxysmal AF, Placebo | 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) | Participants with event | 86 participants |
| Paroxysmal AF, Placebo | 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) | Censored participants | 139 participants |
| Paroxysmal AF, P-OM3 | 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) | Censored participants | 120 participants |
| Paroxysmal AF, P-OM3 | 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) | Participants with event | 86 participants |
| Combined, Placebo | 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) | Participants with event | 15 participants |
| Combined, Placebo | 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) | Censored participants | 34 participants |
| Combined, P-OM3 | 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) | Participants with event | 25 participants |
| Combined, P-OM3 | 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) | Censored participants | 32 participants |
p-value: 0.46195% CI: [0.83, 1.51]Regression, Cox
p-value: 0.20695% CI: [0.79, 2.86]Log Rank
Secondary
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.
Time frame: From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paroxysmal AF, Placebo | Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter | Participants with event | 18 participants |
| Paroxysmal AF, Placebo | Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter | Censored participants | 36 participants |
| Paroxysmal AF, P-OM3 | Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter | Censored participants | 32 participants |
| Paroxysmal AF, P-OM3 | Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter | Participants with event | 32 participants |
| Combined, Placebo | Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter | Participants with event | 147 participants |
| Combined, Placebo | Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter | Censored participants | 176 participants |
| Combined, P-OM3 | Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter | Participants with event | 167 participants |
| Combined, P-OM3 | Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter | Censored participants | 155 participants |
p-value: 0.08995% CI: [0.92, 2.92]Log Rank
p-value: 0.08195% CI: [0.98, 1.52]Regression, Cox
Secondary
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.
Time frame: From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24)
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paroxysmal AF, Placebo | Number Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF/Flutter | Participants with event | 149 participants |
| Paroxysmal AF, Placebo | Number Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF/Flutter | Censored participants | 120 participants |
| Paroxysmal AF, P-OM3 | Number Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF/Flutter | Participants with event | 153 participants |
| Paroxysmal AF, P-OM3 | Number Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF/Flutter | Censored participants | 105 participants |
| Combined, Placebo | Number Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF/Flutter | Censored participants | 27 participants |
| Combined, Placebo | Number Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF/Flutter | Participants with event | 27 participants |
| Combined, P-OM3 | Number Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF/Flutter | Censored participants | 24 participants |
| Combined, P-OM3 | Number Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF/Flutter | Participants with event | 40 participants |
p-value: 0.33195% CI: [0.89, 1.4]Regression, Cox
p-value: 0.29795% CI: [0.79, 2.11]Log Rank