2024-516251-40-01招募中3 期
Multi-Center, Placebo-Controlled, Phase 3 Study of Etripamil Nasal Spray (NS) in Patients with Atrial Fibrillation and Rapid Ventricular Rate (RVR). The ReVeRA-301 Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 18
- 主要终点
- The maximum reduction in ventricular rate, measured from ECG CMS recordings, within 30 minutes from first drug administration.
研究概览
简要总结
Demonstrate the efficacy of etripamil nasal spray over placebo in participants with atrial fibrillation
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double (Analyst, Monitor, Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and over.
- •Provision of written informed consent.
- •Documented history of symptomatic atrial fibrillation (AF, paroxysmal, persistent, or permanent) with a ventricular rate of ≥110 bpm.
- •Documented history of repeated (at least 2 within the prior 12 months) and prolonged (at least 20 minutes) symptomatic episodes of atrial fibrillation (AF) with elevated (perceived or measured) heart rate.
- •Receiving appropriate antithrombotic/anticoagulation therapy as per applicable national and/or local guidelines for atrial fibrillation management.
- •Women of childbearing potential must have a negative pregnancy test at Screening and agree to use at least 1 highly effective form of contraception from time of randomization until 7 days after the last administration of study drug, and must be willing to discontinue from the study should they become or plan to become pregnant.
- •Willing and able to comply with study requirements, including scheduled visits, treatment plan, and study procedures.
排除标准
- •Patients with a primary diagnosis of atrial flutter (typical or atypical) or atrial tachycardia. Patients with atrial fibrillation (AF) who have been observed to also experience atrial flutter within the same episode (i.e., “AFib/Flutter” or an admixture of AF and flutter within the same episode) are eligible.
- •Planned atrial fibrillation or atrioventricular node ablation within the next 3 months.
- •Uncorrected, severe aortic or mitral stenosis.
- •Hypertrophic cardiomyopathy with outflow tract obstruction.
- •History of sensitivity to verapamil or to any components of the investigational product.
- •History of recent or current chronic alcohol or drug abuse that, in the opinion of the Investigator, could impact the validity of the study results.
- •Currently participating in another drug or device study, or has received an investigational drug or device within 30 days prior to Screening.
- •Any other significant co-morbid condition that may negatively impact the patient’s participation in the study or likely result in non-compliance.
- •History of any of the following within the last 6 months: Class 3 or 4 angina per Canadian Cardiovascular Society (CCS) criteria; ischemic chest pain during atrial fibrillation episodes; acute coronary syndrome, unless the patient has been successfully re-vascularized; coronary artery bypass grafting or open-chest valve surgery.
- •History of heart failure (HF) New York Heart Association (NYHA) classification ≥Class III within the last 3 months. (The etiology of any HF should have been previously evaluated and addressed. HF with a reduced ejection fraction and/or HF with a preserved ejection fraction are acceptable).
- •History of hemodynamic instability during atrial fibrillation (AF), e.g., symptoms or signs of severe hypotension or syncope due to a pause upon conversion from AF to sinus rhythm.
- •History of unexplained syncope.
- •History of, or ECG evidence at the screening visit, of: sick sinus syndrome, Mobitz II second- or third-degree atrioventricular block, bradycardia (<40 bpm) or pauses >3 seconds during waking hours, without a pacemaker.
- •History of, or ECG evidence at the screening visit, of: torsades de pointes, ventricular fibrillation, or ventricular tachycardia, Brugada syndrome, an antegrade conducting accessory bypass tract (e.g., Wolff-Parkinson-White or Lown-Ganong-Levine syndromes), or long QT syndrome.
- •History of stroke, transient ischemic attack, or peripheral embolism within the last 3 months.
- •CHA2DS2-VASc score of >5.
研究组 & 干预措施
Etripamil
Test
干预措施: Etripamil (Drug)
Placebo for etripamil nasal spray
Placebo
干预措施: Placebo for etripamil nasal spray (Drug)
结局指标
主要结局
The maximum reduction in ventricular rate, measured from ECG CMS recordings, within 30 minutes from first drug administration.
The maximum reduction in ventricular rate, measured from ECG CMS recordings, within 30 minutes from first drug administration.
次要结局
- Key Secondary Efficacy Variable: Improvement in participant symptoms as measured by a 7-unit anchored Likert scale as measured by ePRO administered 30 minutes after first study drug administration.
- Safety Endpoint: Safety variables will include clinical Adverse Events, vital signs, and findings from ECG CMS recordings.
- Additional secondary efficacy variables will include the following analyses: i) The key secondary efficacy variable (improvement in participant symptoms) as measured by ePRO administered 45 minutes after first study drug administration; ii) Participant satisfaction with how medication relieves their symptoms, as measured by ePRO administered 30 and 45 minutes after first study drug administration;
- Additional secondary efficacy variables will include the following analyses: iii) A comparison of the change in HR from baseline to 30 minutes; iv) A comparison of the proportion of participants who achieve: ≥10% reduction in HR, ≥20% reduction in HR, ≥20 bpm reduction in HR, <100 bpm HR at 30 minutes, analyzed using chi-square test;
- Additional secondary efficacy variables will include the following analyses: v) A comparison of the proportion of participants seeking medical interventions; vi) A comparison of the proportion of participants converting to SR, and the TTC after taking study drug;
- Additional secondary efficacy variables will include the following analyses: vii) A comparison of the time to achieve defined HR reductions; viii) A repeat of the primary and selected secondary estimator analyses at additional timepoints/observation windows including 15, 45, 60, 90, 120, 150, 180, 240, and 300 minutes.
研究者
Information Point
Scientific
Milestone Pharmaceuticals Inc.
研究点 (18)
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