Atrial FibrillationPhase 4AJUARNCT00702117
Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias
A Phase 4 study testing flecainide, ajmaline and procainamide in people with Atrial Fibrillation and Tachycardia, Ventricular, run by Hospital Clinic of Barcelona at 4 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Tachycardia, Ventricular, Brugada Syndrome
- What is being tested?
- flecainide, ajmaline and procainamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 4 sitesSpain
- Study dates
- Jun 2008to Jan 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Servicio de Cardiología, Hospital Clínic
Barcelona, Barcelona, 08036
Hospital Donostia
Donostia / San Sebastian, Guipuzcoa
Hospital Puerta de Hierro
Madrid, Madrid
Hospital La Fe
Valencia, Valencia
About this study
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
- Being tested
- flecainide, ajmaline, procainamide
- Medical subject headings
- Atrial Fibrillation, Tachycardia, Ventricular, Brugada Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flecainideDrug
2 mg/kg iv in 10 minutes
ajmalineDrug
1 mg/kg iv in 10 minutes
procainamideDrug
10 mg/kg iv in 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | IV flecainide in atrial fibrillation Receives: Drug: flecainide |
| B | Experimental | IV ajmaline in atrial fibrillation Receives: Drug: ajmaline |
| c | Active comparator | iv procainamide in ventricular tachycardia Receives: Drug: procainamide |
| d | Experimental | iv ajmaline in ventricular tachycardia Receives: Drug: ajmaline |
| e | Active comparator | iv flecainide in diagnosis of Brugada Sd Receives: Drug: flecainide |
| f | Experimental | iv ajmaline in diagnosis of Brugada Sd Receives: Drug: ajmaline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with reversion of atrial fibrillation
Measured: 1 hour
Proportion of patients with reversion of ventricular tachycardia
Measured: 15 min
Proportion of subjects developing EKG pattern diagnostic of Brugada Sd. after provocation test.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702117
- Sponsor's protocol ID
- AJUAR
- Other IDs
- EudraCT number:2007-006334-33
- Acronym
- AJUAR
- Status last verified
- Jan 2010
- First submitted
- 19 Jun 2008
- Last updated
- 15 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias
- ClinicalTrials.gov ID
- NCT00702117
- Acronym / sponsor ID
- AJUAR / AJUAR
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 20 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: flecainideIV flecainide in atrial fibrillation |
| B | Experimental | Drug: ajmalineIV ajmaline in atrial fibrillation |
| c | Active comparator | Drug: procainamideiv procainamide in ventricular tachycardia |
| d | Experimental | Drug: ajmalineiv ajmaline in ventricular tachycardia |
| e | Active comparator | Drug: flecainideiv flecainide in diagnosis of Brugada Sd |
| f | Experimental | Drug: ajmalineiv ajmaline in diagnosis of Brugada Sd |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flecainide2 mg/kg iv in 10 minutes | Drug | A, e |
| ajmaline1 mg/kg iv in 10 minutes | Drug | B, d, f |
| procainamide10 mg/kg iv in 10 minutes | Drug | c |
Primary outcome
Proportion of patients with reversion of atrial fibrillation
Time frame: 1 hour
Proportion of patients with reversion of ventricular tachycardia
Time frame: 15 min
Proportion of subjects developing EKG pattern diagnostic of Brugada Sd. after provocation test.
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing flecainide, ajmaline and procainamide in people with Atrial Fibrillation and Tachycardia, Ventricular, run by Hospital Clinic of Barcelona at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with reversion of atrial fibrillation (time frame: 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2010.