ReVeRA-301: Etripamil in Atrial Fibrillation Phase 3

Study acronym: ReVeRA-301
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Trial sites expanded: 11 → 15 locations
  2. Trial sites expanded: 3 → 11 locations
    • Eligibility criteria expanded, about 22 words
    • Study description revised
  3. Recruitment openedv6 Show 4 more changesShow less
    • Study sites: 2 to 3
    • Primary completion date: Jan 2029 to Dec 2028
    • Study completion date: Jan 2030 to Dec 2029
    • Start date changed from estimate of Jan 2027 to Aug 20, 2026
  4. Study sites: 0 to 2v5
  5. Primary completion date: Jan 2028 to Jan 2029
    • Start date: Jan 2026 to Jan 2027
    • Study completion date: Jan 2029 to Jan 2030
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Primary completion date: Mar 2027 to Jan 2028
    • Start date: Mar 2025 to Jan 2026
    • Study completion date: Mar 2028 to Jan 2029
    v3
  2. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06716021
Lead Sponsor Milestone Pharmaceuticals Inc.
Conditions
(from sponsor)		 Atrial Fibrillation
Related terms Atrial Fibrillation
Enrollment 750 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov