NCT01710852已完成2 期
A Phase 2 Study to Assess the Antiarrhythmic and Symptomatic Effect of the Second Generation Antisense Oligonucleotide ISIS 329993 Targeting CRP in Patients With Paroxysmal Atrial Fibrillation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- AF burden reduction
研究概览
简要总结
The purpose of this study is to evaluate whether treatment with ISIS CRP Rx can reduce AF (Atrial Fibrillation) burden (percentage of time spent in AF) in subjects with paroxysmal AF
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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
- •Male of female; age over 18 years
- •Dual chamber permanent pacemaker implanted
- •Confirmed diagnosis of paroxysmal atrial fibrillation with an AF burden of 1 to 50%, as derived from pacemaker diagnostic algorithms
- •Able to have pacemaker antiarrhythmic algorithms turned off for the duration of the study
- •Able to discontinue all Class I and III antiarrhythmic medication for the duration of the study
- •Therapeutically anticoagulated with warfarin or dabigatran, and anticipated to be for duration of the study
- •High sensitivity C-Reactive Protein (hsCRP) between 2 and 10 mg/L (inclusive)
排除标准
- •Clinically significant abnormalities in medical history, physical examination, or screening laboratory results that would render a subject unsuitable for inclusion
- •NYHA class III/IV heart failure
- •Impaired left ventricular function of less than 45% determined by echocardiography within 3 months of screening
- •Moderate or greater mitral regurgitation assessed by echocardiography within 3 months of screening
- •Permanent AF
- •Continuous Amiodarone therapy within 90 days prior to Study Day 1
- •Treatment with another Study Drug, biological agent, or device within one-month of screening, or five half-lives of study agent, whichever is longer
- •Use of systemic corticosteroids or other anti-inflammatory medications including non-steroidal anti-inflammatory drugs (NSAIDs)
- •Use of statins, ACE inhibitors or AT-receptor antagonists unless on a stable regimen for at least 3 months prior to dosing and will remain on a stable regimen for the duration of the study
- •Uncontrolled hypertension (BP >160/100)
- •Current or expected use of any anticoagulant apart from warfarin or dabigatran
研究组 & 干预措施
Group A
Experimental
ISIS CRP Rx followed by Placebo
干预措施: ISIS CRP Rx (Drug)
Group A
Experimental
ISIS CRP Rx followed by Placebo
干预措施: Placebo (Drug)
Group B
Experimental
Placebo followed by ISIS CRP Rx
干预措施: ISIS CRP Rx (Drug)
Group B
Experimental
Placebo followed by ISIS CRP Rx
干预措施: Placebo (Drug)
结局指标
主要结局
AF burden reduction
时间窗: 113 Days
Burden measured as percentage of time spent in AF as derived from continuous pacemaker monitoring
次要结局
- To assess whether treatment with ISIS CRP Rx reduces hsCRP in subjects with paroxysmal AF(113 Days)
- To assess the effect of ISIS CRP Rx on the:(113 Days)
- To assess the effect of ISIS CRP Rx on ventricular rate during sinus rhythm(113 Days)
- To assess the effect of ISIS CRP Rx on measures of Quality of Life(113 Days)
- To assess the safety of ISIS CRP Rx in subjects with paroxysmal AF(113 Days)
- To assess the tolerability of ISIS CRP Rx in subjects with paroxysmal AF(113 Days)
- To assess the pharmacokinetics of ISIS CRP Rx in subjects with paroxysmal AF(113 Days)
研究者
研究点 (1)
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