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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00702117
Other study ID # AJUAR
Secondary ID EudraCT number:2
Status Completed
Phase Phase 4
First received June 19, 2008
Last updated December 14, 2010
Start date June 2008
Est. completion date January 2010

Study information

Verified date January 2010
Source Hospital Clinic of Barcelona
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial 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 :

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


Recruitment information / eligibility

Status Completed
Enrollment 123
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 80 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
Spain Servicio de Cardiología, Hospital Clínic Barcelona
Spain Hospital Donostia Donostia Guipuzcoa
Spain Hospital Puerta de Hierro Madrid
Spain Hospital La Fe Valencia

Sponsors (1)

Lead Sponsor Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients with reversion of atrial fibrillation 1 hour No
Primary Proportion of patients with reversion of ventricular tachycardia 15 min No
Primary Proportion of subjects developing EKG pattern diagnostic of Brugada Sd. after provocation test. 1 hour No
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