Treatment of Atrial Fibrillation MedDRA version: 20.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders
Conditions
Sponsors
Milestone Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 4. Patients should receive appropriate antithrombotic therapy as per the applicable guidelines for AF management (e.g. Canadian Cardiovascular Society (CCS) / European Society of Cardiology (ESC) 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 guidelines may start after the administration of study drug. 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 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 months 3. Has received by IV route any of the following within one hour before study drug administration: flecainide, procainamide, digoxin, beta-blocker, or calcium channel 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 blood 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 study. 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 product 17. Signs of alcohol or drug 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, would jeopardize the safety of the patient or impact the validity of study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate the superiority of etripamil NS over placebo in reducing ventricular rate in patients with AF. ;Secondary Objective: The secondary objective is to evaluate the safety and efficacy of etripamil NS in patients with AF. ;Primary end point(s): Ventricular rate reduction ;Timepoint(s) of evaluation of this end point: Efficacy variables will be obtained from the Holter recordings measured by a central core laboratory. In case of conversion to sinus rhythm, only heart rate measurements prior to sinus conversion will be used to derive efficacy variables. The maximum reduction in ventricular rate, measured on Holter monitoring, within 60 minutes from drug administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Elapsed time from drug administration to nadir • Percentage of patients achieving ventricular rate of <100 bpm in the 60 minutes post drug administration. • Percentage of patients with 10% reduction from baseline ventricular rate in the 60 minutes post drug administration. • Percentage of patients with 20% reduction from baseline ventricular rate in the 60 minutes post drug administration. • Percentage of patients cardioverting into sinus rhythm (for at least 30 seconds) in the 60 minutes post drug administration ;Timepoint(s) of evaluation of this end point: 10 minutes pre-administration to 60 minutes after drug administration. | — |
Countries
Canada, Netherlands
Contacts
Public ContactGuy Rousseau
Milestone Pharmaceuticals Inc.
Outcome results
None listed