ReVeRA-201: Etripamil in Atrial Fibrillation, Phase 2

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Many patients experience persistent tachycardia with episodes of rapid ventricular rate despite chronic treatment to reduce ventricular rate. The objectives of this study are to demonstrate the superiority of a nasal spray of etripamil over placebo, in reducing ventricular rate in patients with atrial fibrillation; and to evaluate the safety and efficacy of etripamil Nasal Spray in patients with atrial fibrillation (AF).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Milestone Pharmaceuticals Inc.
• Collaborators: APCER Life Sciences; The Montreal Health Innovations Coordinating Center (MHICC)
• Treatments: Etripamil

Criteria

Inclusion Criteria:

A patient will be eligible for study participation if they meet all of the following criteria:

1. Aged 18 years and over.

2. Has provided written informed consent.

3. Patients with episodes of paroxysmal, persistent or permanent AF (Atrial Fibrillation), presenting with AF for at least 1 hour and heart rate ≥110 bpm (based on standard-of-care ECG (Electrocardiogram).

4. Patients recommended for Oral Anticoagulant (OAC) Therapy per the Canadian Cardiovascular Society algorithm, must be on OAC prior to enrollment. Patients taking a vitamin K antagonist must have an International Normalized Ratio (INR) above 2.

Exclusion Criteria:

A patient will be excluded from the study if they meet any of the following criteria:

1. Has evidence of atrial flutter (ECG) at presentation.

2. Has a history of stroke or Transient Ischemic Attack (TIA) within the last 12 months.

3. History of syncope within the last 12 months.

4. Is currently treated with digoxin or any Class I or III antiarrhythmic drug. Patient may be eligible to participate if these drugs were stopped at least 5 half-lives prior to Screening.

5. Has taken amiodarone within the last 12 weeks.

6. Has a history or evidence of congestive heart failure according to New York Heart Association Class II to IV.

7. Hemodynamic instability, with systolic blood pressure <90 mmHg or diastolic blood pressure <60 mmHg.

8. Known uncorrected severe aortic or mitral stenosis.

9. Hypertrophic cardiomyopathy with outflow tract obstruction

10. Has a history of second- or third-degree atrioventricular block.

11. Regular rhythm suggesting a complete Atrioventricular (AV) block.

12. Has a history or evidence of torsades de pointes, sick sinus syndrome, or Brugada syndrome.

13. Evidence of Acute Coronary Syndrome within the last 12 months.

14. Positive pregnancy test result at the screening visit, and females of childbearing potential who do not agree to use adequate method of contraception for the duration of the study.

15. 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.

16. Has a history of sensitivity to verapamil.

17. Has previously participated in a clinical study for etripamil.

18. Has a history of sensitivity to any components of the investigational product.

19. Alcohol or drugs of abuse intake which, in the opinion of the Investigator, would impact the validity of study results.

20. Is currently participating in another drug or device study, or has received an investigational drug or device within 30 days of Screening.

21. 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 subject or impact the validity of study results.