ReVeRA-201: Etripamil in Atrial Fibrillation, Phase 2
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|ClinicalTrials.gov Identifier: NCT04467905|
Recruitment Status : Recruiting
First Posted : July 13, 2020
Last Update Posted : January 25, 2022
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Drug: Etripamil Drug: Placebo||Phase 2|
This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of etripamil Nasal Spray in patients with atrial fibrillation (AF). This study includes Screening, the Treatment Period and Follow-up procedures.
Each patient will receive placebo or 70 mg of etripamil intranasally; treatment will be randomized in a 1:1 ratio, to yield 50 evaluable patients with atrial fibrillation in 2 groups of 25.
Patients with atrial fibrillation (AF) will be selected by the Investigator. The screening procedures will include a review of inclusion/exclusion criteria and recording of any concomitant medications.
After screening procedures are complete, eligible patients will be randomized to receive etripamil or placebo. Heart rate will be measured via Holter ECG (Electrocardiogram)10 minutes prior to and immediately before drug administration; patients must exhibit a rapid ventricular rate (≥110 bpm measured during 1 minute) prior to drug administration in order to be dosed. Blinded study drug will be administered during Holter ECG (Electrocardiogram) monitoring, which will be conducted for at least 10 minutes prior to and for 6 hours after administration.
Patients will undergo a safety follow-up assessment and return the Holter device approximately 24 hours post-dose. Patients will also be contacted by phone 7 days post-dosing for safety follow-up.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Multi-Centre, Placebo-Controlled, Phase 2 Study of Etripamil Nasal Spray (NS) for the Reduction of Ventricular Rate in Patients With Atrial Fibrillation.|
|Actual Study Start Date :||November 19, 2020|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||September 2022|
Placebo Comparator: Placebo
Patients will receive a total of 200 μL of placebo ((i.e. 100 μL in each nostril) via the Aptar Pharma Nasal Spray Bidose System. The devices will be prefilled and packaged. Instructions on device usage will be provided.
The formulation of placebo will consist of water, sodium acetate, disodium, disodium ethylene-diamine-tetra-acetic acid (EDTA), and sulfuric acid to reproduce the same pH as the etripamil formulation.
Patients will receive a total of 200 μL of etripamil Nasal spray 70 mg via the Aptar Pharma Nasal Spray Bidose System. The devices will be prefilled and packaged. Instructions on device usage will be provided.
The formulation of etripamil Nasal Spray will consist of MSP-2017 (etripamil), water, acetic acid, disodium ethylene-diamine-tetra-acetic acid (EDTA), and sulfuric acid. The dose of etripamil to be evaluated in this study is 70 mg.
- The maximum reduction in ventricular rate, measured on Holter monitoring, within 60 minutes from drug administration. [ Time Frame: 60 minutes post drug administration ]
- The elapsed time from drug administration to nadir (lowest average heart rate) in the 60 minutes post drug administration. [ Time Frame: 60 minutes post drug administration ]
- The percentage of patients achieving ventricular rate of <100 bpm in the 60 minutes post drug administration. [ Time Frame: 60 minutes post drug administration ]
- The percentage of patients with 10% reduction from baseline ventricular rate in the 60 minutes post drug administration. [ Time Frame: 60 minutes post drug administration ]
- The percentage of patients with 20% reduction from baseline ventricular rate in the 60 minutes post drug administration. [ Time Frame: 60 minutes post drug administration ]
- The percentage of patients cardioverting into sinus rhythm (for at least 30 seconds) in the 60 minutes post drug administration. [ Time Frame: 60 minutes post drug administration ]
- Rating of Treatment Satisfaction Questionnaire for Medication (TSQM). [ Time Frame: 60 minutes post drug administration ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04467905
|Contact: Douglas Wight, MSc||+1-514-336-0444 ext firstname.lastname@example.org|
|Contact: Francis Plat, M.D||+1-514-336-0444 ext email@example.com|
|CIUSSS de l'Estrie-Centre Haute-Yamaska - Hôpital de Granby||Recruiting|
|Granby, Quebec, Canada, J2G 1T7|
|CISSS de Laval - Cité-de-la-Santé||Recruiting|
|Laval, Quebec, Canada, H7M 3L9|
|Institut de Cardiologie de Montreal||Recruiting|
|Montréal, Quebec, Canada, H1T 1C8|
|Montréal, Quebec, Canada, H2X 0A9|
|CIUSSS du Nord-de-l'Île-de-Montréal - Hôpital du Sacré-Cœur||Recruiting|
|Montréal, Quebec, Canada, H4J 1C5|
|CHU de Québec-Université Laval - Hôtel Dieu de Québec||Recruiting|
|Québec, Quebec, Canada, G1R 2J6|
|CISSS Bas-Saint-Laurent / Hôpital de Rimouski||Recruiting|
|Rimouski, Quebec, Canada, G5L 5T1|
|CISSS des Laurentides / Unité de recherche clinique||Recruiting|
|Saint-Jérôme, Quebec, Canada, J7Z 5T3|
|CIUSSS de l'Estrie - CHU||Recruiting|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|CISSS de Lanaudière - Hôpital Pierre-Le Gardeur||Recruiting|
|Terrebonne, Quebec, Canada, J6V 2H2|
|CIUSSS Mauricie-Centre-du-Québec - CHAUR||Recruiting|
|Trois-Rivières, Quebec, Canada, G8Z 3R9|
|Principal Investigator:||Denis Roy, M.D||Montreal Heart Institute (MHI)|