NCT00402363已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 663
- 试验地点
- 1
- 主要终点
- Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
omega-3-acid ethyl esters
Experimental
干预措施: omega-3-acid ethyl esters (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter
时间窗: 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.
次要结局
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
研究者
研究点 (1)
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