Vernakalant Versus Ibutilide In Recent-Onset Atrial Fibrillation

Vernakalant Versus Ibutilide In Recent-Onset Atrial Fibrillation - Verna-Ibu-AF

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000695-34-AT

Enrollment

100

Registered

2011-06-22

Start date

2011-07-22

Completion date

Unknown

Last updated

2020-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

recent-onset atrial fibrillation MedDRA version: 13.1 Level: LLT Classification code 10034039 Term: Paroxysmal atrial fibrillation System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: Brinavess Pharmaceutical Form: Concentrate and solvent for solution for infusion CAS Number: 748810-28-8 Other descriptive name: VERNAKALANT HYDROCHLORIDE Concentration unit: mg/kg milligr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Symptoms of atrial fibrillation since no longer than 48 hours • Age 18 – 90 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: • Need for immediate electrical cardioversion due to hemodynamic instability (hypotension: systolic blood pressure 440 milliseconds • Wolff–Parkinson–White (WPW) syndrome • History of Torsade de pointes arrhythmias or other polymorphic ventricular tachycardias • Signs of thyreotoxicosis • Sick Sinus Syndrome or atrioventricular block greater than first degree • Severe valvular heart disease • Serious disorders of the hepatic, renal (Creatinine > 2.5mg/dl), pulmonary, gastrointestinal, hematologic or central nervous system and serious psychiatric disorders • Abnormal serum electrolytes despite adequate therapy (especially potassium 5.5 mmol/l) • Intravenous use of other Class I or III antiarrythmic drugs within 4 hours of study drug application • Pregnancy (for women < 50 years, ß-HCG test will be performed) • Known hypersensitivity to study medication

Design outcomes

Primary

Measure	Time frame
Main Objective: to compare the time duration and the efficacy of cardioversion between the two rapid-acting antiarrhythmic drugs vernakalant and ibutilide in patients with recent-onset atrial fibrillation admitted to the emergency medicine ward of a tertiary care hospital.;Secondary Objective: to compare conversion to sinus rhythm rates within 90 minutes between subjects treated with vernakalant and ibutilide. to compare conversion to sinus rhythm rates including electrical cardioversion between subjects treated with vernakalant and ibutilide. ;Primary end point(s): Time in minutes until conversion to sinus rhythm;Timepoint(s) of evaluation of this end point: n.a.	—

Measure

Time frame

Main Objective: to compare the time duration and the efficacy of cardioversion between the two rapid-acting antiarrhythmic drugs vernakalant and ibutilide in patients with recent-onset atrial fibrillation admitted to the emergency medicine ward of a tertiary care hospital.;Secondary Objective: to compare conversion to sinus rhythm rates within 90 minutes between subjects treated with vernakalant and ibutilide. to compare conversion to sinus rhythm rates including electrical cardioversion between subjects treated with vernakalant and ibutilide. ;Primary end point(s): Time in minutes until conversion to sinus rhythm;Timepoint(s) of evaluation of this end point: n.a.

—

Secondary

Measure	Time frame
Secondary end point(s): Conversion rate to sinus rhythm within 90 minutes Conversion rate to sinus rhythm including electrical cardioversion;Timepoint(s) of evaluation of this end point: 90 minutes	—

Countries

Austria

Contacts

Public ContactAlexander Spiel

Medical University of Vienna, Department of Emergency Medicine

alexander.spiel@meduniwien.ac.at+431404003953

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026