Phase III clinical study of TY-0201 in patients with chronic atrial fibrillation -Confirmatory Study-

TOA EIYO LTD.1 个研究点目标入组 188 人开始时间: 待定最近更新: 2019年4月25日

试验速览

暂无简介。

研究类型: Interventional
干预模型: Multicenter, randomized, double-blind, parallel-group, comparative study
主要目的: Treatment Purpose

•(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, 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.

efficacy The change of mean heart rate as determined by 24 hours holter electrocardiogram.

发起方

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