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ReVeRA-301: Etripamil in Atrial Fibrillation Phase 3
EU CTIS ID: 2024-516251-40-01
What this study is testing
Demonstrate the efficacy of etripamil nasal spray over placebo in participants with atrial fibrillation
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 18 years and over.
- Provision of written informed consent.
- Documented history of symptomatic atrial fibrillation (AF, paroxysmal, persistent, or permanent) with a ventricular rate of ≥110 bpm.
- Documented history of repeated (at least 2 within the prior 12 months) and prolonged (at least 20 minutes) symptomatic episodes of atrial fibrillation (AF) with elevated (perceived or measured) heart rate.
- Receiving appropriate antithrombotic/anticoagulation therapy as per applicable national and/or local guidelines for atrial fibrillation management.
- Women of childbearing potential must have a negative pregnancy test at Screening and agree to use at least 1 highly effective form of contraception from time of randomization until 7 days after the last administration of study drug, and must be willing to discontinue from the study should they become or plan to become pregnant.
You likely can't join if
- Patients with a primary diagnosis of atrial flutter (typical or atypical) or atrial tachycardia. Patients with atrial fibrillation (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.
- Planned atrial fibrillation or atrioventricular node ablation within the next 3 months.
- Uncorrected, severe aortic or mitral stenosis.
- Hypertrophic cardiomyopathy with outflow tract obstruction.
- History of sensitivity to verapamil or to any components of the investigational product.
- History of recent or current chronic alcohol or drug abuse that, in the opinion of the Investigator, could impact the validity of the study results.
See the full eligibility criteria
Who can join
- Age 18 years and over.
- Provision of written informed consent.
- Documented history of symptomatic atrial fibrillation (AF, paroxysmal, persistent, or permanent) with a ventricular rate of ≥110 bpm.
- Documented history of repeated (at least 2 within the prior 12 months) and prolonged (at least 20 minutes) symptomatic episodes of atrial fibrillation (AF) with elevated (perceived or measured) heart rate.
- Receiving appropriate antithrombotic/anticoagulation therapy as per applicable national and/or local guidelines for atrial fibrillation management.
- Women of childbearing potential must have a negative pregnancy test at Screening and agree to use at least 1 highly effective form of contraception from time of randomization until 7 days after the last administration of study drug, and must be willing to discontinue from the study should they become or plan to become pregnant.
- Willing and able to comply with study requirements, including scheduled visits, treatment plan, and study procedures.
What rules you out
- Patients with a primary diagnosis of atrial flutter (typical or atypical) or atrial tachycardia. Patients with atrial fibrillation (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.
- Planned atrial fibrillation or atrioventricular node ablation within the next 3 months.
- Uncorrected, severe aortic or mitral stenosis.
- Hypertrophic cardiomyopathy with outflow tract obstruction.
- History of sensitivity to verapamil or to any components of the investigational product.
- History of recent or current chronic alcohol or drug abuse that, in the opinion of the Investigator, could impact the validity of the study results.
- Currently participating in another drug or device study, or has received an investigational drug or device within 30 days prior to Screening.
- Any other significant co-morbid condition that may negatively impact the patient’s participation in the study or likely result in non-compliance.
- 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 atrial fibrillation episodes; acute coronary syndrome, unless the patient has been successfully re-vascularized; 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. HF with a reduced ejection fraction and/or HF with a preserved ejection fraction are acceptable).
- History of hemodynamic instability during atrial fibrillation (AF), e.g., symptoms or signs of severe hypotension or syncope due to a pause upon conversion from AF to sinus rhythm.
- History of unexplained syncope.
- History of, or ECG evidence at the screening visit, of: sick sinus syndrome, Mobitz II second- or third-degree atrioventricular block, bradycardia (<40 bpm) or pauses >3 seconds during waking hours, without a pacemaker.
- History of, or ECG evidence at the screening visit, of: torsades de pointes, ventricular fibrillation, or ventricular tachycardia, Brugada syndrome, an antegrade conducting accessory bypass tract (e.g., Wolff-Parkinson-White or Lown-Ganong-Levine syndromes), or long QT syndrome.
- History of stroke, transient ischemic attack, or peripheral embolism within the last 3 months.
- CHA2DS2-VASc score of >5.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.