ReVeRA-301: Etripamil in Atrial Fibrillation Phase 3
ConditionAtrial Fibrillation
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMilestone Pharmaceuticals Inc.
About 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.
Eligibility criteria
Qualifiers
Age 18 years and over.
Provision of written informed consent.
Documented history of symptomatic AF (paroxysmal, persistent, or permanent) with a ventricular rate of ≥110 bpm.
Documentation: electrocardiogram (ECG) tracing (including 12-lead ECG or ECG strip) showing AF with ventricular rate ≥110 beats per minute (bpm). This ECG documentation (anonymized with study Patient ID only) will be submitted to the Sponsor after screening and prior to randomization to confirm diagnosis of AF with RVR and eligibility to be randomized in the study. Patients who have undergone a prior ablation procedure for AF or for an AF-trigger must have documented AF with RVR post-ablation for study eligibility.
Disqualifiers
Patients with a primary diagnosis of atrial flutter (typical or atypical) or atrial tachycardia. Patients with AF who have been observed to also experience atrial flutter within the same episode (i.e., "AFib/Flutter" or an admixture of AF and flutter within the same episode) are eligible.
History of any of the following within the last 6 months: Class 3 or 4 angina per Canadian Cardiovascular Society (CCS) criteria; ischemic chest pain during AF episodes; acute coronary syndrome, unless the patient has been successfully revascularized; coronary artery bypass grafting or open-chest valve surgery.
History of heart failure (HF) New York Heart Association (NYHA) classification ≥Class III within the last 3 months.
The etiology of any HF should have been previously evaluated and addressed.
Trial design
Treatments tested in this trial
- Placebo
- Etripamil
Treatment groups
750 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov