JPRN-jRCT2080222737已完成3 期
Phase III clinical study of TY-0201 in patients with chronic atrial fibrillation -Confirmatory Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 220
研究概览
简要总结
TY-0201 was confirmed to be non-inferior to the BO for reducing the heart rate in Japanese patients with persistent or permanent atrial fibrillation. Furthermore, the treatments were considered to be tolerable from a safety point of view.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 80age old（—）
- 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.
- •1) Acute coronary syndrome, coronary revascularization or variant angina within 6 months prior to informed consent.
- •2) Cardioversion or catheter ablation within 3 months prior to informed consent.
- •3) Heart rate control with a pacemaker, etc.
- •4) Severe arrhythmia, cardiogenic shock, heart failure, cardiomyopathy, myocarditis or reduced cardiac function, or aortic or mitral valve stenosis or regurgitation at a moderate level or higher.
- •(2) Patients with a history of a cerebrovascular event (except an asymptomatic cerebrovascular event).
- •(3) Systolic blood pressure < 110 mmHg.
- •(4) Patients with a disease for which anticoagulant therapy is contraindicated.
- •(5) Patients with poor skin condition at the patch application site or history of dermatitis caused by a topical agent.
研究者
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