EUCTR2020-004327-17-DE进行中（未招募）1 期
A randomized, placebo-controlled, investigator- and participant-blinded study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of HSY244 in participants with atrial fibrillation
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 13
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. At screening, written informed consent must be obtained before any
- •assessment is performed. Only participants able to provide written
- •informed consent themselves will be included in this study.
- •2. Hemodynamically stable men and women between 18 and 80 years of
- •age inclusive at screening with a clinical indication for direct current
- •cardioversion of Atrial Fibrillation.
- •3. At screening, current episode of AF has been ongoing for =6 hours and
- •4. Successful initiation and achievement of therapeutic levels of national
- •guideline and institution-specific anticoagulation therapy as appropriate
- •for the duration of the Atrial Fibrillation episode and risk for the
- •participant.
- •5. Completion of national guideline and institution-specific imaging
- •evaluation for left atrial thrombi as appropriate for the duration of Atrial
- •Fibrillation episode and risk for the participant.
- •6. At screening, participants must weigh at least 60 kg to participate in
- •the study, and must have a body mass index (BMI) within the range of
- •18 - 45 kg/m2. BMI = Body weight (kg) / [Height (m)]2
- •7. At screening, vital signs (systolic blood pressure and pulse rate) will
- •be assessed in the sitting position. Sitting vital signs should be within
- •the following ranges (exclusive):
- •- systolic blood pressure between 100-160 mmHg and diastolic blood pressure 60-100 mmHg
- •- pulse rate (ventricular rate) between 60-120 bpm
- •8. Able to communicate well with the investigator, to understand and
- •comply with the requirements of the study.
- •Other inclusion criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. Women of child-bearing potential unless they are using highly effective methods of contraception
- •2. Pregnant or nursing (lactating) women.
- •3. Sexually active males unwilling to use a condom during intercourse
- •4. Use of a QT prolonging drug within 5 half-lives before randomization
- •5. History or current diagnosis of ECG abnormalities or cardiac rhythm disorders
- •6. Clinically significant sinus node dysfunction and/or presence of a permanent pacemaker.
- •7. Attempted or unsuccessful cardioversion within 2 weeks prior to randomization
- •8. History of 2 or more ablation procedures for Atrial Fibrillation
- •9. Presence of a left atrial thrombus that may pose a risk of embolization with cardioversion
- •10. Presence of known severe mitral regurgitation and/or known severely dilated left atrium.
- •11. Pre-existing or tachycardia-induced moderate to severe cardiac dysfunction (New York Heart Association Class III and IV).
- •12. History within the preceding 3 months prior to randomization of: myocardial infarction, unstable angina, cardiac surgery, or a percutaneous coronary intervention.
- •13. History of a confirmed stroke or transient ischemic attack (TIA).
- •14. History or current diagnosis of any seizure disorder, epilepsy, significant head trauma, or other disorders increasing the risk for seizures.
- •15. History or current diagnosis of a major neurologic or psychiatric disorder that in the opinion of the Investigator poses a risk to patient safety to participate.
- •16. Moderately or greater impaired renal function
- •17. Liver disease or liver injury
- •18. Donation or loss of 450 mL or more of blood within eight weeks prior to randomization, or longer if required by local regulation.
- •19. Have any other conditions which, in the opinion of the Investigator, would make the patient unsuitable for inclusion or could interfere with the patient participating in or completing the study
- •20. Significant illness and/or infection which has not resolved within two (2) weeks prior to randomization.
- •Other exclusion criteria may apply
研究者
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