Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06716021 | ReVeRA-301: Etripamil in Atrial Fibrillation Phase 3 | PHASE3 | NOT YET_RECRUITING | 750 | — | — | Jan 1, 2027 | Jan 1, 2030 | Jan 14, 2026 | - | — |
| NCT04467905 | ReVeRA-201: Etripamil in Atrial Fibrillation, Phase 2 | PHASE2 | COMPLETED | 69 | — | — | Nov 19, 2020 | Aug 10, 2023 | Sep 19, 2024 | 18 | Canada, Netherlands |
The maximum reduction in ventricular rate, measured from ECG CMS recordings, within 30 minutes from first drug administration
Baseline ventricular rate is defined as the average heart rate over 5 minutes immediately prior to drug administration. Nadir is defined as the lowest moving average heart rate over 5 minutes recorded in the 60 minutes post drug administration.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | 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. |
| Etripamil | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: 1. Age 18 years and over. 2. Provision of written informed consent. 3. 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) showi...