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Antiarrhythmic Agent
Vernakalant vs. Procainamide for Atrial Fibrillation
Phase 4
Recruiting
Led By Ian G Stiell, MD, MSc
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients who have been adequately anticoagulated for a minimum of 3 weeks (warfarin and INR > 2.0 or novel oral anticoagulants [dabigatran, rivaroxaban, edoxaban, and apixaban])
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of infusion start until time of conversion to sinus rhythm (approximately 0 - 90 minutes)
Awards & highlights
Study Summary
This trial is comparing two drugs for treating AF- vernakalant and procainamide. The primary aim is to compare conversion to normal sinus rhythm between the two drugs.
Who is the study for?
This trial is for stable patients with acute non-valvular atrial fibrillation lasting between 3 hours to 7 days, needing urgent care but not immediate cardioversion. Participants must have been anticoagulated for at least 3 weeks or meet specific criteria if not. Exclusions include severe heart conditions, recent serious cardiovascular events, certain medication use, and inability to consent.Check my eligibility
What is being tested?
The RAFF4 Trial compares IV vernakalant and IV procainamide in emergency department management of acute atrial fibrillation (AF). Patients are randomly assigned to receive either vernakalant over a potential two-dose infusion or a continuous procainamide infusion. The main goal is to see which drug better converts AF back to normal rhythm.See study design
What are the potential side effects?
Potential side effects of both drugs may include changes in blood pressure, dizziness, nausea, altered heart rhythms including potentially dangerous arrhythmias. Vernakalant might cause taste disturbances while procainamide could lead to a lupus-like syndrome in long-term use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on blood thinners for at least 3 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time of infusion start until time of conversion to sinus rhythm (approximately 0 - 90 minutes)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of infusion start until time of conversion to sinus rhythm (approximately 0 - 90 minutes)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Conversion to sinus rhythm for a minimum duration of 30 minutes
Secondary outcome measures
Adverse events
Length of stay in ED
Normal sinus rhythm
+4 moreOther outcome measures
Death
Maintenance of normal sinus rhythm
Recurrence of acute AF
+2 moreTrial Design
2Treatment groups
Active Control
Group I: VernakalantActive Control1 Intervention
Patients randomized to this arm will receive an initial infusion of 3 mg/kg infused over a 10-minute period by a pre-programmed IV pump.82 For patients ≤ 100 kg the infusion is prepared by adding 25 mL of BRINAVESS 20 mg/mL to 100 mL of diluent creating a total volume of 125 mL at a concentration of 4 mg/mL. For patients > 100 kg the infusion is prepared by adding 30 mL of BRINAVESS 20 mg/mL to 120 mL of diluent creating a total volume of 150 mL at a concentration of 4 mg/mL. For patients weighing ≥ 113 kg, the maximum initial dose is 339 mg (84.7 mL of 4 mg/mL solution).
Group II: ProcainamideActive Control1 Intervention
Patients randomized to this arm will receive a continuous infusion of IV procainamide with a dose of 15 mg/kg in 500 mL of normal saline given over 60 minutes (maximum dose 1,500 mg), by a pre-programmed pump. While the CAEP Best Practices Checklist suggests an infusion time of 30-60 minutes, we believe that a 60-minute period will avoid some adverse events.
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Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
563 Previous Clinical Trials
2,787,377 Total Patients Enrolled
6 Trials studying Atrial Fibrillation
5,473 Patients Enrolled for Atrial Fibrillation
Ian G Stiell, MD, MScPrincipal InvestigatorOttawa Hospital Research Institute
1 Previous Clinical Trials
396 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
396 Patients Enrolled for Atrial Fibrillation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken specific heart rhythm medications recently.You had a recent episode of fast or irregular heartbeats, and the doctor knows when it started based on your symptoms.I have chronic atrial fibrillation.I do not have severe slow heart rate, heart rhythm problems without a working pacemaker, or Brugada syndrome.I am at a higher risk of stroke and either wasn't treated with blood thinners in time or don't meet certain health criteria.You were first diagnosed with a different condition like pneumonia, pulmonary embolism, or sepsis.Your blood pressure is too low (less than 100 mmHg).My heart rhythm returned to normal on its own before treatment started.I have severe narrowing of my heart's aortic valve.I recently had a heart attack or severe heart failure.I have been given an IV beta-blocker in the last 2 hours.I have been on blood thinners for at least 3 weeks.I haven't been on blood thinners for over 3 weeks, no stroke/TIA history, no heart valve disease, and fit one of the specific time or health criteria.My heart's electrical activity (QT interval) is longer than normal.I have been diagnosed with atrial flutter.I have severe heart failure or my heart's pumping ability is very weak.My liver disease is in an advanced or end-stage.I have a heart valve condition.I need urgent heart treatment due to low blood pressure, rapid heartbeat, chest pain with ECG changes, or severe breathing difficulty.You have already been part of this study before.You are allergic to the main ingredient in the drug or any of its other ingredients.I have a recent and unstable heart rhythm issue not caused by valve problems.
Research Study Groups:
This trial has the following groups:- Group 1: Vernakalant
- Group 2: Procainamide
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the enrolment size for this research endeavor?
"Affirmative, according to the information made available through clinicaltrials.gov, this medical trial is in active recruitment phase and has accepted applications since June 17th 2021. This experiment requires 340 volunteers obtained from 14 different sites and was last revised on July 12th 2022."
Answered by AI
Are there any unfilled vacancies in this clinical investigation?
"According to clinicaltrials.gov, the search for patients is still ongoing as of this writing. This study was initially announced on June 17th 2021 and has been kept up-to-date since then, with its last update being July 12th 2022."
Answered by AI
How many venues is this experiment conducted in?
"Presently, 14 sites are recruiting participants for this clinical trial. Localities such as Hamilton, Montreal, and Ottawa have been chosen along with a further 11 cities. It may be wise to select the closest medical centre in order to limit travel needs should you elect to participate."
Answered by AI
What are the primary medical applications of Vernakalant?
"Vernakalant is traditionally utilized to manage atrial fibrillation, but has also been successfully employed in the treatment of supraventricular arrhythmias, tachycardia and even life-threatening ventricular arrhythmias."
Answered by AI
To what extent is Vernakalant secure for human consumption?
"The safety of Vernakalant is rated as a 3 on our scale due to its approval in Phase 4 trials."
Answered by AI
Have any other research efforts been undertaken regarding Vernakalant?
"Vernakalant was initially researched in 2017 at Hospital Clínico Universitario San Carlos. Presently, there are 13 concluded trials and 4 ongoing clinical investigations with a considerable portion of such tests being done out of Hamilton, Ontario."
Answered by AI
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