Vernakalant Versus Amiodarone for Post-operative Atrial Fibrillation in Cardiac Surgery Patients

NCT04748991 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: REB20-2257
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Post-operative atrial fibrillation is a common problem post cardiac surgery with rates exceeding 30%. Atrial fibrillation has multiple adverse effects on cardiac hemodynamics and can lead to hypotension, diminished end organ perfusion and lengthen the stay in ICU. Amiodarone is the medication of choice used for pharmacological cardioversion and can be used with vasoactive medications. Intravenous amiodarone is associated with hypotension and end organ perfusion requiring escalation in vasoactive support. Vernakalant is novel anti-arrhythmic agent approved in Canada for cardioversion of atrial fibrillation that primarily works on atrial channels and has no effect on contractility or vasodilation. Clinical trials have proved good efficacy of Vernakalant in conversion of paroxysmal atrial fibrillation however there is no comparison of Amiodarone to Vernakalant in post-operative cardiac surgery. We plan to perform a clinical trial comparing Vernakalant to amiodarone in post-cardiac surgery patients with a primary outcome of cardioversion at 90 minutes. Secondary outcomes will follow duration of vasoactive medications, days in ICU and economics.

Conditions

Atrial Fibrillation; Post-cardiac Surgery

Keywords

Amiodarone; Vernakalant

Outcome Measures

Primary Outcomes (1)

• Rate of conversion of sustained post-operative atrial fibrillation at 90 minutes.

  Rate of conversion of sustained post-operative atrial fibrillation at 90 minutes.

  90 minutes

Secondary Outcomes (8)

• Duration of vasopressor therapy

  7 days

• Time to conversion to sinus rhythm

  7 days

• Days in intensive care unit

  7 Days

• Recurrence of atrial fibrillation within 48 hours

  48 hours

• Mortality

  1 month

Study Arms (2)

Intravenous Vernakalant

EXPERIMENTAL

Patients randomized to Vernakalant will receive a bolus of 3mg/kg over 10 minutes and an observation period of 15 minutes, if the patient is still in AF, they will receive an additional 2.0mg/kg bolus of Vernakalant.

Drug: Vernakalant

Intravenous Amiodarone

ACTIVE COMPARATOR

Patients randomized to an amiodarone arm will receive 150mg IV bolus and an amiodarone infusion of 1mg/hr x 6 hours followed by 0.5mg/hr x 12 hours.

Drug: Amiodarone

Interventions

Vernakalant DRUG

Post operative AF after cardiac surgery. Vernakalant 3mg/kg over 10 minutes followed by 2mg/kg over 10 minutes if still in AF.

Also known as: BRINAVESS

Intravenous Vernakalant

Amiodarone DRUG

Post operative AF after cardiac surgery. Amiodarone 150mg IV followed by 1 mg/min x 6 hours then 0.5 mg/min x 12 hours

Also known as: Cordarone, Nexterone, Pacerone

Intravenous Amiodarone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>/=18 years
• Undergone heart surgery for coronary artery bypass surgery (on-pump or off-pump CABG) and/or valve repair or replacement (excluding mechanical valves), including re-operations.
• Hemodynamically stable with/without vasopressor support

You may not qualify if:

• LVAD insertion or heart transplantation
• MAZE procedure
• Transcatheter aortic valve replacement (TAVR)
• History of or planned mechanical valve replacement
• Rheumatic heart disease
• Congenital cardiac defect (excluding bicuspid aortic valve or patent foramen ovale)
• History of prior atrial fibrillation or flutter
• History of ablation for atrial fibrillation
• Contraindication to amiodarone
• PR \>240ms
• Heart block (2nd or 3rd degree)
• QTC \>480ms
• Untreated thyroid disorder
• AST or ALT \>2x upper limit of normal
• Hepatic cirrhosis

Sponsors & Collaborators

• University of Calgary: lead

Related Publications (3)

• Roy D, Pratt CM, Torp-Pedersen C, Wyse DG, Toft E, Juul-Moller S, Nielsen T, Rasmussen SL, Stiell IG, Coutu B, Ip JH, Pritchett EL, Camm AJ; Atrial Arrhythmia Conversion Trial Investigators. Vernakalant hydrochloride for rapid conversion of atrial fibrillation: a phase 3, randomized, placebo-controlled trial. Circulation. 2008 Mar 25;117(12):1518-25. doi: 10.1161/CIRCULATIONAHA.107.723866. Epub 2008 Mar 10.

  PMID: 18332267 BACKGROUND

• Kowey PR, Dorian P, Mitchell LB, Pratt CM, Roy D, Schwartz PJ, Sadowski J, Sobczyk D, Bochenek A, Toft E; Atrial Arrhythmia Conversion Trial Investigators. Vernakalant hydrochloride for the rapid conversion of atrial fibrillation after cardiac surgery: a randomized, double-blind, placebo-controlled trial. Circ Arrhythm Electrophysiol. 2009 Dec;2(6):652-9. doi: 10.1161/CIRCEP.109.870204.

  PMID: 19948506 BACKGROUND

• Camm AJ, Capucci A, Hohnloser SH, Torp-Pedersen C, Van Gelder IC, Mangal B, Beatch G; AVRO Investigators. A randomized active-controlled study comparing the efficacy and safety of vernakalant to amiodarone in recent-onset atrial fibrillation. J Am Coll Cardiol. 2011 Jan 18;57(3):313-21. doi: 10.1016/j.jacc.2010.07.046.

  PMID: 21232669 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

vernakalant; Amiodarone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Michael Chiu, MD, MSC

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Chiu, MD, MSC

CONTACT

4032106818; michael.chiu@albertahealthservices.ca

Vikas Kuriachan, MD

CONTACT

4032106818; vpkuriac@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be recruited from the CVICU 24 hours after admission to CIVCU based on inclusion and exclusion criteria. Patients identified with new presentation atrial fibrillation with a sustained duration of greater than 30 minutes will be considered for the study. Patients will be randomized to Amiodarone versus Vernakalant using a computerized process.

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 10, 2021
• Study Start: September 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share