Angiotensin II-Antagonist in Paroxysmal Atrial Fibrillation Trial (ANTIPAF Trial)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 422
- 主要终点
- Percentage of days with documented episodes of paroxysmal atrial fibrillation (number of days with paroxysmal atrial fibrillation/number of days with at least one readable Tele-ECG recording)
研究概览
简要总结
Hypothesis:
Blocking the angiotensin (AT) II type 1 receptor (Olmesartan) reduces the incidence of episodes of atrial fibrillation in patients with paroxysmal atrial fibrillation during 12 months by more than 25% compared to standard medication without angiotensin II type 1 receptor.
A total of 422 subjects will be included in the two study groups. The treatment arm will receive 40mg Olmesartan per day, the remaining patients will receive placebo. Follow-up is 12 months. Daily Tele-ECG recordings will determine the cardiac rhythm and asymptomatic episodes of atrial fibrillation (AF) every day. Concomitant therapy with AV-nodal blocking drugs are allowed during the study. In case of severe AF-induced symptoms, an antiarrhythmic "recovery medication" (amiodarone) is allowed during follow-up.
详细描述
Double-blind, central randomization, two treatment groups, stratified by beta-blocker use. 211 patients in each treatment arm.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Documented paroxysmal atrial fibrillation: ECG documentation of atrial fibrillation at least in one ECG recorded during the last 2 months prior to randomization plus additional ECG recording of sinus rhythm at least 12 hours after the above mentioned ECG documentation.
- •Patient informed orally and in writing
- •Written informed consent of the patient
排除标准
- •Strong clinical evidence for therapy with AT II/ACE inhibitors
- •AT II/ACE inhibitor therapy within the last month
- •Therapy with antiarrhythmic agents of class I or class III within the last month, therapy with amiodarone within the last 3 months
- •Direct current (DC) cardioversion within the last 3 months
- •Symptomatic bradycardia
- •Implanted pacemaker or implanted cardioverter/defibrillator with any antitachycardiac algorithm in use
- •Cardiac surgery or cardiac catheter ablation within the last 3 months
- •Typical angina pectoris symptoms at rest or during exercise
- •Known coronary artery disease with indication for intervention
- •Valvular disease > II degree
- •Left ventricular ejection fraction < 40%
- •Diastolic blood pressure > 110mm Hg at rest
- •Symptomatic arterial hypotension
- •Known renal artery stenosis
- •Serum creatinine > 1.8 mval/l
- •Relevant hepatic or pulmonary disorders
- •Hyperthyroidism manifested clinically and in laboratory
- •Known drug intolerance for AT II inhibitors
- •Females who are pregnant or breast feeding
- •Females of childbearing potential who are not using a scientifically accepted method of contraception
- •Participation in a clinical trial within the last 30 days
- •Drug addiction or chronic alcohol abuse
- •Legal incapacity, or other circumstances which would prevent the patient from understanding the aim, nature or extent of the clinical study
- •Evidence of an uncooperative attitude
研究组 & 干预措施
Olmesartan
Olmesartan tablet, 1 in the morning
干预措施: Olmesartan (Drug)
Placebo
Placebo tablets, 1 in the morning
干预措施: Olmesartan (Drug)
结局指标
主要结局
Percentage of days with documented episodes of paroxysmal atrial fibrillation (number of days with paroxysmal atrial fibrillation/number of days with at least one readable Tele-ECG recording)
时间窗: 12 months follow-up
次要结局
- Time to first occurrence of a documented relapse of atrial fibrillation(12 months follow up)
- Time to first occurrence of a symptomatic documented episode of AF(12 months follow up)
- Time to persistent atrial fibrillation(12 months follow up)
- Time to prescription of the recovery-medication(12 months follow up)
- Number of hospitalizations for cardiovascular reasons (-> Endpoint review)(12 months follow up)
- Number of intermediate medical visits for cardiovascular reasons (-> Endpoint review) without hospitalization(12 months follow up)
- Number of cerebrovascular events(12 months follow up)
- Quality of life(12 months follow up)