NCT00702117

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 :

  1. 1.recent-onset atrial fibrillation versus iv flecainide
  2. 2.sustained monomorphous ventricular tachycardia versus iv procainamide

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P25-P50 for phase_4 atrial-fibrillation

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_4 atrial-fibrillation

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

December 15, 2010

Status Verified

January 1, 2010

Enrollment Period

1.6 years

First QC Date

June 19, 2008

Last Update Submit

December 14, 2010

Conditions

Atrial FibrillationTachycardia, VentricularBrugada Syndrome

Outcome Measures

Primary Outcomes (3)

  • Proportion of patients with reversion of atrial fibrillation

    1 hour

  • Proportion of patients with reversion of ventricular tachycardia

    15 min

  • Proportion of subjects developing EKG pattern diagnostic of Brugada Sd. after provocation test.

    1 hour

Study Arms (6)

A

ACTIVE COMPARATOR

IV flecainide in atrial fibrillation

Drug: flecainide

B

EXPERIMENTAL

IV ajmaline in atrial fibrillation

Drug: ajmaline

c

ACTIVE COMPARATOR

iv procainamide in ventricular tachycardia

Drug: procainamide

d

EXPERIMENTAL

iv ajmaline in ventricular tachycardia

Drug: ajmaline

e

ACTIVE COMPARATOR

iv flecainide in diagnosis of Brugada Sd

Drug: flecainide

f

EXPERIMENTAL

iv ajmaline in diagnosis of Brugada Sd

Drug: ajmaline

Interventions

flecainideDRUG

2 mg/kg iv in 10 minutes

Ae
ajmalineDRUG

1 mg/kg iv in 10 minutes

Bdf
procainamideDRUG

10 mg/kg iv in 10 minutes

c

Eligibility Criteria

Age10 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • General: Pregnancy
  • AF: Pre-existing heart disease.
  • Secondary AF
  • nd 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.
  • nd and 3rd degree AV block or RBBB associated with LAFB or LPFB (bifascicular block).
  • Moderate-severe liver failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Servicio de Cardiología, Hospital Clínic

Barcelona, Barcelona, 08036, Spain

Location

Hospital Donostia

Donostia / San Sebastian, Guipuzcoa, Spain

Location

Hospital Puerta de Hierro

Madrid, Madrid, Spain

Location

Hospital La Fe

Valencia, Valencia, Spain

Location

MeSH Terms

Conditions

Atrial FibrillationTachycardia, VentricularBrugada Syndrome

Interventions

FlecainideAjmalineProcainamide

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsTachycardiaCardiac Conduction System DiseaseGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesBenzamidesAmidesOrganic Chemicalspara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 19, 2008

First Posted

June 20, 2008

Study Start

June 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

December 15, 2010

Record last verified: 2010-01

Locations

ES(4)