ReVeRA-201: Etripamil in Atrial Fibrillation, Phase 2
Canada69 participantsStarted 2020-11-19
Plain-language summary
Many patients with atrial fibrillation (AF) experience persistent tachycardia with episodes of rapid ventricular rate despite chronic treatment to reduce ventricular rate. The objectives of this study were to demonstrate the superiority of a nasal spray of etripamil over placebo in reducing ventricular rate in patients with AF; and to evaluate the safety and efficacy of etripamil nasal spray in participants with AF.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Aged 18 years and over.
ā. Provided written informed consent.
ā. Participants with episodes of paroxysmal, persistent or permanent AF, presenting with AF and a ventricular rate ā„110 bpm, measured over 1 minute
ā. Participants received appropriate antithrombotic therapy as per the applicable guidelines for atrial fibrillation management (e.g., Canadian Cardiovascular Society (CCS) guidelines / European Society of Cardiology (ESC) guidelines).
ā. Etripamil (a calcium channel blocker) was intended for acute rate control only. If rhythm control was desired (outside of the present protocol), anticoagulation as per guidelines could be started after the administration of study drug.
Exclusion criteria
ā. Had evidence of atrial flutter (ECG) at presentation.
ā. Had a history of stroke, transient ischemic attack (TIA) or peripheral embolism within the last 3 months.
ā. Had received by IV route any of the following within one hour before study drug administration: flecainide, procainamide, digoxin, beta-blocker, or calcium channel blocker.
ā. Had signs and symptoms of severe congestive heart failure at presentation (e.g. tachypnea, oxygen desaturation \<90% unless due to known pulmonary disease, pulmonary rales, sign of peripheral hypoperfusion).
ā. Hemodynamic instability, with systolic blood pressure \<90 mmHg or diastolic blood pressure \<60 mmHg.
What they're measuring
1
The Maximum Reduction in Ventricular Rate, Measured on Holter Monitoring, Within 60 Minutes From Drug Administration.