jRCT2080222649已完成3 期
Phase III clinical study of TY-0201 in patients with chronic atrial fibrillation -long-term study-
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multicenter, open-label study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 80age old under（—）
- 性别
- All
入选标准
- •(1) Patients with chronic (persistent or permanent) atrial fibrillation.
- •(2) Resting heart rate: >=80 bpm
- •(3) Outpatients
排除标准
- •(1) Patients with any of the following findings related to heart disease.
- •Acute coronary syndrome, coronary revascularization or variant angina within 6 months prior to informed consent.
- •Cardioversion or catheter ablation within 3 months prior to informed consent.
- •Heart rate control with a pacemaker, etc.
- •Severe arrhythmia, cardiogenic shock, heart failure, cardiomyopathy, myocarditis or reduced cardiac function, aortic valve or mitral valve with moderate or severe valve stenosis or valve regurgitation.
- •(2) Patients with a history of a cerebrovascular event (except for asymptomatic cerebrovascular events).
- •(3) Systolic blood pressure < 110 mmHg.
- •(4) Patients contraindicated for anticoagulation therapy.
- •(5) Patients with poor skin condition at the site of patch application or a history of clinically significant dermatitis caused by a topical agent, etc.
结局指标
主要结局
-
safety Adverse events and adverse drug reactions
次要结局
未报告次要终点
研究者
研究点 (1)
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