NL-OMON51562已完成2 期
Multi-Centre, Placebo-Controlled, Phase 2 Study of Etripamil Nasal Spray (NS) for the Reduction of Ventricular Rate in Patients with Atrial Fibrillation - ReVeRA-201
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Aged 18 years and over
- •2. Has provided written informed consent
- •3. Patients with episodes of paroxysmal, persistent or permanent AF, presenting
- •with AF and a ventricular rate >=110 bpm, measured over 1 minute on an ECG
- •4. Patients should receive appropriate antithrombotic therapy as per Canadian
- •Cardiovascular Society (CCS) guidelines.
- •a. Etripamil (a calcium channel blocker) is intended for acute rate control
- •only. If rhythm control is desired (outside of the present protocol),
- •anticoagulation as per CCS guidelines may start after the administration of
- •study drug.
排除标准
- •1. Has evidence of atrial flutter (ECG) at presentation
- •2. Has a history of stroke, transient ischemic attack, or peripheral embolism
- •within the last 3
- •3. Has received by IV route any of the following within one hour before study
- •administration: flecainide, procainamide, digoxin, beta-blocker, or calcium
- •chanel blocker
- •4. Has signs and symptoms of severe congestive heart failure at presentation
- •(e.g. tachypnea,
- •oxygen desaturation <90% unless due to known pulmonary disease, pulmonary
- •rales, sign
- •of peripheral hypoperfusion)
- •5. Hemodynamic instability, with systolic blood pressure <90 mmHg or diastolic
- •pressure <60 mmHg
- •6. Known uncorrected severe aortic or mitral stenosis
- •7. Hypertrophic cardiomyopathy with outflow tract obstruction
- •8. Has a history of second- or third-degree atrioventricular block
- •9.Regular rhythm suggesting a complete AV block
- •10. Has a history or evidence of torsades de pointes, sick sinus syndrome, or
- •Brugada syndrome
- •11. Evidence of Acute Coronary Syndrome within the last 12 months except if
- •patient was
- •successfully revascularized
- •12. Positive pregnancy test result at screening, and females of childbearing
- •potential who do
- •not agree to use adequate method of contraception for the duration of the
- •13. Has evidence of any clinically significant acute or chronic condition of
- •the nasal cavity
- •(e.g., rhinitis or deviated septum) which could interfere with administration
- •of the study
- •drug in either or both nasal cavities
- •14. Has a history of sensitivity to verapamil
- •15. Has previously participated in a clinical study for etripamil
- •16. Has a history of sensitivity to any components of the investigational
- •17. Signs of alcohol or drugs intoxication at the time of presentation which,
- •in the opinion of
- •the Investigator, would impact the validity of study results;
- •18. Is currently participating in another drug or device study, or has received
- •an investigational
- •drug or device within 30 days of Screening
- •19. Has evidence of clinically significant cardiovascular, endocrine,
- •gastrointestinal,
- •hematologic, hepatic, immunologic, neurologic, oncologic, pulmonary,
- •psychiatric, or
- •renal disease or any other condition which, in the opinion of the Investigator,
- •jeopardize the safety of the patient or impact the validity of study results.
研究者
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