Official Title: “Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias”

The study evaluates 3 different populations:

It is an open, randomized, parallel-group study comparing the effectiveness of intravenous (iv) ajmaline with currently used antiarrhythmic drugs in the acute treatment of :

1. recent-onset atrial fibrillation versus iv flecainide

2. sustained monomorphous ventricular tachycardia versus iv procainamide

The study also evaluates in an open, randomized, crossover study, the use of iv ajmaline versus iv flecainide in the diagnosis of Brugada syndrome

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2009

Intervention(s) in this Clinical Trial

• Drug: flecainide
  • 2 mg/kg iv in 10 minutes
• Drug: ajmaline
  • 1 mg/kg iv in 10 minutes
• Drug: procainamide
  • 10 mg/kg iv in 10 minutes

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
  • IV flecainide in atrial fibrillation
• Experimental: B
  • IV ajmaline in atrial fibrillation
• Active Comparator: c
  • iv procainamide in ventricular tachycardia
• Experimental: d
  • iv ajmaline in ventricular tachycardia
• Active Comparator: e
  • iv flecainide in diagnosis of Brugada Sd
• Experimental: f
  • iv ajmaline in diagnosis of Brugada Sd

Primary Measures

• Proportion of patients with reversion of atrial fibrillation
  • Time Frame: 1 hour
    Safety Issue?: No
• Proportion of patients with reversion of ventricular tachycardia
  • Time Frame: 15 min
    Safety Issue?: No
• Proportion of subjects developing EKG pattern diagnostic of Brugada Sd. after provocation test.
  • Time Frame: 1 hour
    Safety Issue?: No

Inclusion Criteria:

• AF: Patients with isolated, idiopathic, sustained, symptomatic, recent onset(>10 minutes to <24 hours) atrial fibrillation.
• VT: Patients with ventricular tachycardia with good haemodynamic tolerability attending the emergency room or induced at the electrophysiology lab during testing for ventricular arrhythmias.
• Brugada Sd (BrS): First-degree relatives of a patient with Brugada Syndrome with a ECG non-diagnostic of the BrS.

Exclusion Criteria:

• General: Pregnancy
• AF: Pre-existing heart disease.
• Secondary AF
• 2nd and 3rd degree AV block or RBBB associated with LAFB or LPFB (bifascicular block).
• LVF<40%.
• Moderate-severe liver failure.
• AF with haemodynamic compromise.
• VT:VT with haemodynamic compromise.
• BrS:Pre-existing heart disease.
• 2nd and 3rd degree AV block or RBBB associated with LAFB or LPFB (bifascicular block).
• Moderate-severe liver failure.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 10 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hospital Clinic of Barcelona

Overall Clinical Trial Officials and Contacts

Overall Contact: Jose Brugada, MD +34932275703 jbrugada@clinic.ub.es

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00702117

Study ID Number: AJUAR

ClinicalTrials.gov Identifier: NCT00702117

Health Authority: Spain: Spanish Agency of Medicines