ReVeRA-301: Etripamil in Atrial Fibrillation Phase 3
Sponsor: Milestone Pharmaceuticals Inc. • ClinicalTrials.gov ID: NCT06716021
Recruiting for Similar Conditions?
Sponsors are looking for patients like you. See if you qualify for compensated research studies.
Check Eligibility →Description
This is a multi-national, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of etripamil NS in patients with atrial fibrillation (AF). This study includes Screening Visit, Randomization Visit, a Treatment Period with scheduled Follow-up Visits (Monthly Follow-up and Post-treatment Follow-up Visits), a Final Study Visit, and an End of Study Telephone Follow up Visit. Each patient will be randomized 1:1 to receive placebo or 70 mg Etripamil NS regimens. Patients will self-administer study drug for a perceived episode of AF with RVR with an initial dose of placebo or 70 mg etripamil NS, followed by an optional second dose of the same study drug 10 minutes after the first dose if the patient continues to experience symptoms. Patients may treat up to a maximum of 4 episodes in the study. Informed consent will be obtained prior to any study procedures.
Interventions
-
Placebo
(Drug)
The formulation of placebo will consist of water, sodium acetate, disodium EDTA, and sulfuric acid to reproduce the same pH as the etripamil formulation.
-
Etripamil
(Drug)
The formulation of etripamil is for IN administration and will consist of 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 with an optional second dose of 70 mg 10 minutes after the first dose if symptoms persist.
Eligibility criteria
Conditions
Locations
- Interventional Cardiology Medical Group (West Hills, CA) — West Hills, California, United States
- South Denver Cardiology Associates P.C — Littleton, Colorado, United States
- Cardiovascular Associates Of The Delaware Valley — Haddon Heights, New Jersey, United States
- Weill Cornell Medicine — Manhattan, New York, United States
- Montreal Heart Institute — Montreal, Quebec, Canada
- Gelre Ziekenhuizen — Apeldoorn, Gelderland, Netherlands
- Rijnstate Ziekenhuis — Arnhem, Gelderland, Netherlands
- Jeroen Bosch Ziekenhuis — 's-Hertogenbosch, North Brabant, Netherlands
- Elkerliek Ziekenhuis — Helmond, North Brabant, Netherlands
- Bravis ziekenhuis — Roosendaal, North Brabant, Netherlands
- Noordwest Ziekenhuisgroep — Alkmaar, North Holland, Netherlands
- ZGT — Almelo, Overijssel, Netherlands
- Van Weel-Bethesda Ziekenhuis — Dirksland, South Holland, Netherlands
- Ikazia Ziekenhuis — Rotterdam, South Holland, Netherlands
- Frisius Medisch Centrum — Friesland, Netherlands
Partner with Nurenyx
Showcase your study to thousands of motivated patients matching your criteria.
Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
View Official Record