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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number:2007-006334-33 |
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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 :
The study also evaluates in an open, randomized, crossover study, the use of iv ajmaline versus iv flecainide in the diagnosis of Brugada syndrome
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | IV flecainide in atrial fibrillation |
|
| B | Experimental | IV ajmaline in atrial fibrillation |
|
| c | Active Comparator | iv procainamide in ventricular tachycardia |
|
| d | Experimental | iv ajmaline in ventricular tachycardia |
|
| e | Active Comparator | iv flecainide in diagnosis of Brugada Sd |
|
| f | Experimental | iv ajmaline in diagnosis of Brugada Sd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| flecainide | Drug | 2 mg/kg iv in 10 minutes |
| |
| ajmaline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Servicio de CardiologÃa, Hospital ClÃnic | Barcelona | Barcelona | 08036 | Spain | ||
| Hospital Donostia |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D017180 | Tachycardia, Ventricular |
| D053840 | Brugada Syndrome |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D005424 | Flecainide |
| D000404 | Ajmaline |
| D011342 | Procainamide |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D046948 | Secologanin Tryptamine Alkaloids |
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| Drug |
1 mg/kg iv in 10 minutes |
|
| procainamide | Drug | 10 mg/kg iv in 10 minutes |
|
| Donostia / San Sebastian |
| Guipuzcoa |
| Spain |
| Hospital Puerta de Hierro | Madrid | Madrid | Spain |
| Hospital La Fe | Valencia | Valencia | Spain |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |