2025-523807-31-00招募中2 期
[22961] A placebo-controlled, parallel-group, double blind, randomized, multi-cohort Phase 2 study to investigate efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of BAY 3670549 in adult participants with atrial fibrillation.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Bayer AG
- 入组人数
- 105
- 试验地点
- 39
- 主要终点
- Participants with conversion from atrial fibrillation (AF) to sinus rhythm (SR), sustained for ≥1 minute, within 3 hours after start of study intervention administration, and prior to use of rescue therapy or other SoC for cardioversion
研究概览
简要总结
To determine the efficacy of BAY 3670549 in restoring sinus rhythm (SR) in with patients AF
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participant must be 18 to 85 years of age inclusive, at the time of signing the informed consent.
- •Participant is hemodynamically stable and does not require emergency cardioversion, as determined by the Investigator.
- •Participant has a current episode of AF ongoing for at least 3 hours and no more than 30 days at the time of randomization.
- •Participant has an indication for electrical cardioversion of AF, as determined by the investigator according to standard clinical practice and national/institutional guidelines.
- •At randomization, successful initiation and achievement of therapeutic levels of anticoagulation therapy, as well as completion of imaging evaluation for left atrial thrombi, as appropriate for the duration of the AF episode and risk for the participant according to national guideline and institution-specific routine practice.
- •BMI within range [18 – 39.9] kg/m
- •Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- •Willing and able to comply with the receipt, home use, and return of the continuous electrocardiogram (ECG) recording device, as well as with the participation in scheduled telephone follow-up assessments.
排除标准
- •Current atrial flutter (AFL) or combined AF/AFL
- •Use of anti-arrhythmic class I or III drugs within 5 half-lives before study drug administration (oral amiodarone in the previous 3 months)
- •Hypertension with SBP ≥ 180 mmHg or hypotension (SBP < 90 mmHg) at randomization (based on the second BP measurement)
- •Stressor-associated AF, i.e., in the setting of an acute and reversible stressor (e.g., cardiac surgery, myocarditis, endocarditis, sepsis, pneumonia, etc.). This includes ablation procedure within the preceding one month prior to randomization.
- •Contraindication for electrical cardioversion on planned study intervention administration day
- •Documented severely dilated left atrium (left atrial diameter, LAD >5 cm) measured by any modality within the 6 months prior to screening; if several values are available, the most recent one shall be reported. If left atrium diameter was not measured in the last 6 months or a major cardiovascular event occurred within the last 6 months, a new measurement must be done at screening
- •Unsuccessful conversion of current AF episode (pharmacologically or electrically)
- •Known severe valvular heart disease (e.g., severe mitral regurgitation, severe aortic stenosis)
- •Patients with NYHA Class ≥ III heart failure, or with active management of acute heart failure decompensation on treatment day.
- •History within the preceding 3 months prior to randomization of any of the following events, or any other significant cardiovascular event as judged by the investigator: • Stroke • Myocardial infarction • Unstable angina pectoris or other signs of myocardial ischemia • Cardiac surgery • Transcatheter valve replacement • Percutaneous coronary intervention (PCI) • Coronary artery bypass graft (CABG) or other revascularization procedure
- •Severe renal impairment, i.e., estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m² (using CKD-EPI formula) or requiring dialysis
- •Severe hepatic impairment, i.e. Child Pugh Class C
研究组 & 干预措施
Placebo to BAY 3670549
Placebo
干预措施: Placebo to BAY 3670549 (Drug)
BAY 3670549 Bayer
Test
干预措施: BAY 3670549 Bayer (Drug)
结局指标
主要结局
Participants with conversion from atrial fibrillation (AF) to sinus rhythm (SR), sustained for ≥1 minute, within 3 hours after start of study intervention administration, and prior to use of rescue therapy or other SoC for cardioversion
Participants with conversion from atrial fibrillation (AF) to sinus rhythm (SR), sustained for ≥1 minute, within 3 hours after start of study intervention administration, and prior to use of rescue therapy or other SoC for cardioversion
次要结局
- Participants who experienced Treatment Emergent Adverse Events (TEAE)s
- Time to conversion from AF to SR as defined in the primary endpoint
- Participants in SR, at 3 hours after start of study intervention administration without prior use of rescue therapy or other SoC for cardioversion
- Plasma concentration of BAY 3670549 at the end of the infusion
研究者
Therapeutic Area Head
Scientific
Bayer AG
研究点 (39)
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