Multi-Center, Placebo-Controlled, Phase 3 Study of Etripamil Nasal Spray (NS) in Patients With Atrial Fibrillation and Rapid Ventricular Rate (RVR)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 750
- 试验地点
- 5
- 主要终点
- Demonstrate the efficacy of etripamil NS over placebo in patients with AF.
研究概览
简要总结
This is a multi-national, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of etripamil NS in patients with atrial fibrillation (AF). This study includes Screening Visit, Randomization Visit, a Treatment Period with scheduled Follow-up Visits (Monthly Follow-up and Post-treatment Follow-up Visits), a Final Study Visit, and an End of Study Telephone Follow up Visit.
Each patient will be randomized 1:1 to receive placebo or 70 mg Etripamil NS regimens. Patients will self-administer study drug for a perceived episode of AF with RVR with an initial dose of placebo or 70 mg etripamil NS, followed by an optional second dose of the same study drug 10 minutes after the first dose if the patient continues to experience symptoms. Patients may treat up to a maximum of 4 episodes in the study.
Informed consent will be obtained prior to any study procedures.
详细描述
This is a multi-national, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of etripamil NS in patients with AF. This study includes a Screening Visit, Randomization Visit, Treatment Period with Follow-up Visits (Monthly Follow-up Visits, and Post-treatment Follow-up Visits), a Final Study Visit, and an End of Study Telephone Follow-up Visit.
Each patient will be randomized in a 1:1 ratio to receive Placebo or 70 mg Etripamil NS regimens. Patients will self-administer study drug for a perceived episode of AF with RVR as follows: an initial dose of placebo or 70 mg etripamil NS, followed by an optional second dose 10 minutes after the first dose if the patient continues to experience symptoms.
Patients may treat up to a maximum of 4 episodes in the study. Informed consent must be obtained prior to any study procedures.
Screening Visit:
Patients with a history of symptomatic AF with RVR will be selected by the Investigator. The screening procedures will include obtaining informed consent, a review of inclusion/exclusion criteria, vital signs, a physical examination, measuring height and weight, screening lab tests, 12-lead electrocardiogram (ECG), recording demographics and medical history and recording of any concomitant medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 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 AF (paroxysmal, persistent, or permanent) with a ventricular rate of ≥110 bpm.
- •Documentation: electrocardiogram (ECG) tracing (including 12-lead ECG or ECG strip) showing AF with ventricular rate ≥110 beats per minute (bpm). This ECG documentation (anonymized with study Patient ID only) will be submitted to the Sponsor after screening and prior to randomization to confirm diagnosis of AF with RVR and eligibility to be randomized in the study. Patients who have undergone a prior ablation procedure for AF or for an AF-trigger must have documented AF with RVR post-ablation for study eligibility.
- •Documented history of repeated (at least 2 within the prior 12 months) and prolonged (at least 20 minutes) symptomatic episodes of AF with elevated (perceived or measured) heart rate (HR).
- •Documentation: Patient description, other history, or medical records. Patients who have undergone a prior ablation procedure for AF or for an AF-trigger must fulfill this criterion post-ablation for study eligibility.
- •Receiving appropriate antithrombotic/anticoagulation therapy as per applicable national and/or local guidelines for AF 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.
排除标准
- •Patients with a primary diagnosis of atrial flutter (typical or atypical) or atrial tachycardia. Patients with 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.
- •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 AF episodes; acute coronary syndrome, unless the patient has been successfully revascularized; 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 AF, i.e., symptoms or signs of severe hypotension, or syncope due to a pause upon conversion from AF to sinus rhythm (SR).
- •History of unexplained syncope.
- •History of, or ECG evidence at the screening visit, of: sick sinus syndrome, Mobitz II second- or third-degree atrioventricular (AV) 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 >
- •Planned AF or AV 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.
研究组 & 干预措施
Etripamil
Patients will self-administer an initial dose of etripamil for a perceived episode of AF with RVR, followed by an optional second dose 10 minutes later if symptoms persist.
干预措施: Etripamil (Drug)
Placebo
Patients will self-administer an initial dose of placebo for a perceived episode of AF with RVR, followed by an optional second dose 10 minutes later if symptoms persist.
干预措施: Placebo (Drug)
结局指标
主要结局
Demonstrate the efficacy of etripamil NS over placebo in patients with AF.
时间窗: 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
未报告次要终点