Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias - Tabular View

Tracking Information

First Received Date ^ICMJE

June 19, 2008

Last Updated Date

January 28, 2009

Start Date ^ICMJE

June 2008

Current Primary Outcome Measures ^ICMJE

Proportion of patients with reversion of atrial fibrillation [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Proportion of patients with reversion of ventricular tachycardia [ Time Frame: 15 min ] [ Designated as safety issue: No ]
Proportion of subjects developing EKG pattern diagnostic of Brugada Sd. after provocation test. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00702117 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias

Official Title ^ICMJE

Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias

Brief Summary

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 :

recent-onset atrial fibrillation versus iv flecainide
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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Atrial Fibrillation
Tachycardia, Ventricular
Brugada Syndrome

Intervention ^ICMJE

Drug: flecainide
Drug: ajmaline
Drug: procainamide

Study Arms / Comparison Groups

Active Comparator: IV flecainide in atrial fibrillation
Experimental: IV ajmaline in atrial fibrillation
Active Comparator: iv procainamide in ventricular tachycardia
Experimental: iv ajmaline in ventricular tachycardia
Active Comparator: iv flecainide in diagnosis of Brugada Sd
Experimental: iv ajmaline in diagnosis of Brugada Sd

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

December 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

10 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jose Brugada, MD

+34932275703

jbrugada@clinic.ub.es

Location Countries ^ICMJE

Spain

Administrative Information

NCT ID ^ICMJE

NCT00702117

Responsible Party

José Brugada, Hospital Clinic de Barcelona

Study ID Numbers ^ICMJE

AJUAR, EudraCT number:2007-006334-33

Study Sponsor ^ICMJE

Hospital Clinic of Barcelona

Collaborators ^ICMJE

Investigators ^ICMJE

Information Provided By

Hospital Clinic of Barcelona

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP