Etripamil for Atrial Fibrillation
(ReVeRA-301 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
James E. Ip, MD
Principal Investigator
Weill Medical College of Cornell University
Are You a Good Fit for This Trial?
This trial is for adults with a history of at least two episodes in the past year of atrial fibrillation (AF) lasting over 20 minutes, with fast heart rates. Participants must be on proper blood thinners and women who could become pregnant need to use effective birth control.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Randomization
Eligible participants are randomized to receive either placebo or etripamil NS and trained on study procedures
Treatment
Participants self-administer study drug during episodes of AF with RVR, with up to 4 episodes treated
Follow-up
Monthly follow-up visits to monitor AEs and concomitant medications, with post-treatment follow-up within 14 days after each treated episode
Final Study Visit
Final assessment after the last administration of study drug, including collection of devices and study drug kits
End of Study Telephone Follow-Up
Telephone follow-up to monitor ongoing AEs approximately 30 days after the Final Study Visit
What Are the Treatments Tested in This Trial?
Trial Overview
The study tests Etripamil nasal spray versus placebo for treating sudden AF episodes. Patients are randomly assigned to either group and self-administer the spray during an episode, possibly repeating after 10 minutes if needed. The trial is double-blind so neither patients nor doctors know which treatment is given.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Patients will self-administer an initial dose of etripamil for a perceived episode of AF with RVR, followed by an optional second dose 10 minutes later if symptoms persist.
Patients will self-administer an initial dose of placebo for a perceived episode of AF with RVR, followed by an optional second dose 10 minutes later if symptoms persist.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Milestone Pharmaceuticals Inc.
Lead Sponsor
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