Status:
COMPLETED
ReVeRA-201: Etripamil in Atrial Fibrillation, Phase 2
Lead Sponsor:
Milestone Pharmaceuticals Inc.
Collaborating Sponsors:
The Montreal Health Innovations Coordinating Center (MHICC)
JSS Medical Research Inc.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Many patients with atrial fibrillation (AF) experience persistent tachycardia with episodes of rapid ventricular rate despite chronic treatment to reduce ventricular rate. The objectives of this study...
Detailed Description
This was a multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of etripamil nasal spray in participants with AF. This study included Screening, the Treatment Perio...
Eligibility Criteria
Inclusion
- A participant was eligible for study participation if they met all of the following criteria:
- Aged 18 years and over.
- Provided written informed consent.
- Participants with episodes of paroxysmal, persistent or permanent AF, presenting with AF and a ventricular rate ≥110 bpm, measured over 1 minute
- Participants received appropriate antithrombotic therapy as per the applicable guidelines for atrial fibrillation management (e.g., Canadian Cardiovascular Society (CCS) guidelines / European Society of Cardiology (ESC) guidelines).
- Etripamil (a calcium channel blocker) was intended for acute rate control only. If rhythm control was desired (outside of the present protocol), anticoagulation as per guidelines could be started after the administration of study drug.
Exclusion
- A participant was excluded from the study if they met any of the following criteria:
- Had evidence of atrial flutter (ECG) at presentation.
- Had a history of stroke, transient ischemic attack (TIA) or peripheral embolism within the last 3 months.
- Had received by IV route any of the following within one hour before study drug administration: flecainide, procainamide, digoxin, beta-blocker, or calcium channel blocker.
- Had 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).
- Hemodynamic instability, with systolic blood pressure \<90 mmHg or diastolic blood pressure \<60 mmHg.
- Known uncorrected severe aortic or mitral stenosis.
- Hypertrophic cardiomyopathy with outflow tract obstruction.
- Had a history of second- or third-degree atrioventricular block.
- Regular rhythm suggesting a complete atrioventricular block.
- Had a history or evidence of torsades de pointes, sick sinus syndrome, or Brugada syndrome.
- Evidence of acute coronary syndrome within the last 12 months except if participant was successfully revascularized.
- Positive pregnancy test result at screening, and females of childbearing potential who did not agree to use adequate method of contraception for the duration of the study.
- Had evidence of any clinically significant acute or chronic condition of the nasal cavity (e.g., rhinitis or deviated septum) which could have interfered with administration of the study drug in either or both nasal cavities.
- Had a history of sensitivity to verapamil.
- Had previously participated in a clinical study for etripamil.
- Had a history of sensitivity to any components of the investigational product.
- Had signs of alcohol or drug intoxication at the time of presentation which, in the opinion of the Investigator, would have impacted the validity of study results.
- Was participating in another drug or device study, or had received an investigational drug or device within 30 days of Screening.
- Had 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 have jeopardized the safety of the participant or impacted the validity of study results.
Key Trial Info
Start Date :
November 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2023
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT04467905
Start Date
November 19 2020
End Date
August 10 2023
Last Update
September 19 2024
Active Locations (18)
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1
QEII HSC - Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H 3A7
2
Hamilton Health Science
Hamilton, Ontario, Canada, L2L 2X2
3
PACE (Partners in Advanced Cardiac Evaluation)
Newmarket, Ontario, Canada, L3Y 2P6
4
Ottawa Hospital General & Civic Campus Research Institute
Ottawa, Ontario, Canada, K1Y4E9