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Antiarrhythmic Agent

Vernakalant vs. Procainamide for Atrial Fibrillation

Ottawa, Canada

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

Must not have

Patients who have received an intravenous antiarrhythmic drug Class I, e.g. procainamide, or Class Ill, e.g. amiodarone or ibutilide, within the prior 4 hours; or currently takes oral class I or III antiarrhythmic drugs other than amiodarone (last dose < 5 half-lives before enrollment)

Patients with permanent (chronic) AF

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

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

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.

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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 below

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I have been on blood thinners for at least 3 weeks.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken specific heart rhythm medications recently.

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I have chronic atrial fibrillation.

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I do not have severe slow heart rate, heart rhythm problems without a working pacemaker, or Brugada syndrome.

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My heart rhythm returned to normal on its own before treatment started.

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I have severe narrowing of my heart's aortic valve.

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My heart's electrical activity (QT interval) is longer than normal.

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I have been diagnosed with atrial flutter.

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I have severe heart failure or my heart's pumping ability is very weak.

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My liver disease is in an advanced or end-stage.

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I have a heart valve condition.

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I need urgent heart treatment due to low blood pressure, rapid heartbeat, chest pain with ECG changes, or severe breathing difficulty.

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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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of infusion start until time of conversion to sinus rhythm (approximately 0 - 90 minutes) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Conversion to sinus rhythm for a minimum duration of 30 minutes

Secondary study objectives

Adverse events

Length of stay in ED

Normal sinus rhythm

+4 more

Other study objectives

Death

Maintenance of normal sinus rhythm

Recurrence of acute AF

+2 more

Awards & Highlights

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.

Trial 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.

0 / 12Eligibility criteria met