Iv Amiodarone Versus Iv Procainamide to Treat Haemodynamically Well Tolerated Ventricular Tachycardia
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ClinicalTrials.gov Identifier: NCT00383799 |
Recruitment Status
:
Terminated
(Steering Committee decision after inclusion of 74 patients after 6 years and very slow inclusion rate)
First Posted
: October 4, 2006
Last Update Posted
: April 6, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ventricular Tachycardia Wide QRS Tachycardia | Drug: iv Amiodarone Drug: iv Procainamide | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 302 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Comparison of Intravenous Amiodarone Versus Intravenous Procainamide for the Acute Treatment of Regular and Haemodynamically Well Tolerated Wide QRS Tachycardia (Probably of Ventricular Origen). The PROCAMIO Multicenter Study |
Study Start Date : | September 2005 |
Actual Primary Completion Date : | June 2011 |
Actual Study Completion Date : | June 2011 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Group 1
IV procainamide (single dose: 10 mg/kg over 20 min)
|
Drug: iv Procainamide |
Active Comparator: Group 2
IV Amiodarone (single dose: 5 mg/kg over 20 min)
|
Drug: iv Amiodarone |
- To compare clinically significant cardiac adverse events occurring within 40 minutes from treatment initiation [ Time Frame: 40 minutes ]
- To compare efficacy of both therapies in relation to episode termination [ Time Frame: 40 minuutes ]
- To compare the rate of total adverse events, cardiac and non cardiac, occurring during an observation period of 24 hours after treatment was applied [ Time Frame: 24 hours ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with stable tachycardia ≥120 lpm, QRS ≥120 ms and haemodynamically well tolerated defined as: 1)Systolic blood pressure ≥90 mmHg, 2) absence of dyspnea at rest, 3)absence of peripheric hypoperfusion signs and 4)no severe angina.
- Age > 18 years
- Written inform consent obtained
Exclusion Criteria:
- Treatment with iv amiodarone or iv procainamide during the previous 24 hours
- QRS tachycardia <120 ms
- Patients with QRS ≥120 ms tachycardia with haemodynamic compromise that requires urgent cardioversion for termination
- Irregular tachycardia
- Tachycardia that is considered as supraventricular due to physician criteria (adenosine and/or vagal manoeuvres response)
- Patient that do not want to cooperate

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00383799
Spain | |
Hospital El Escorial | |
El Escorial, Madrid, Spain | |
Hospital Universitario de Getafe | |
Getafe, Madrid, Spain | |
Hospital Santa María del Rosell | |
Cartagena, Murcia, Spain | |
Fundación Hospitalaria de Cieza | |
Cieza, Murcia, Spain | |
Hospital Los Arcos | |
San Javier, Murcia, Spain | |
Hospital General | |
Alicante, Spain | |
Hospital Clinic | |
Barcelona, Spain | |
Hospital Vall d'Hebron | |
Barcelona, Spain | |
Hospital de Basurto | |
Bilbao, Spain | |
Hospital San Cecilio | |
Granada, Spain | |
Hospital Virgen de las Nieves | |
Granada, Spain | |
Hospital General Universitario Gregorio Marañón | |
Madrid, Spain, 28007 | |
Hospital 12 de Octubre | |
Madrid, Spain | |
Hospital Clínico San Carlos | |
Madrid, Spain | |
Hospital de La Princesa | |
Madrid, Spain | |
Hospital de Móstoles | |
Madrid, Spain | |
Hospital General Universitario La Paz | |
Madrid, Spain | |
Hospital Puerta de Hierro | |
Madrid, Spain | |
Hospital Carlos Haya | |
Malaga, Spain | |
Hospital Virgen de la Arrixaca | |
Murcia, Spain | |
Hospital Clínico Virgen de la Victoria | |
Málaga, Spain | |
Hospital de Son Dureta | |
Palma de Mallorca, Spain | |
Hospital de Son Llatzer | |
Palma de Mallorca, Spain | |
Hospital de Donostia | |
San Sebastián, Spain | |
Hospital de Valme | |
Sevilla, Spain | |
Hospital Universitario Virgen del Rocío | |
Sevilla, Spain | |
Hospital Virgen de la Salud | |
Toledo, Spain | |
Hopital Clínico Universitario | |
Valencia, Spain | |
Hospital Río Hortega | |
Valladolid, Spain |
Principal Investigator: | Jesús Almendral, MD | Hospital General Universitario Gregorio Marañón. Madrid. Spain | |
Study Director: | Fernando Arribas, MD | Hospital General Universitario 12 de Octubre. Madrid. Spain | |
Study Director: | Rafael Peinado, MD | Hospital General Universitario La Paz. Madrid. Spain | |
Study Director: | Alfonso Martín, MD | Hospital de Móstoles. Madrid. Spain | |
Study Director: | Carmen del Arco, MD | Hospital de la Princesa. Madrid. Spain | |
Study Director: | Dolores Vigil, MD | Hospital general Universitario Gregorio Marañón. Madrid. Spain | |
Study Director: | Mercedes Ortiz, PhD | Hospital General Universitario Gregorio Marañón. Madrid. Spain | |
Study Director: | Blanca Coll-Vinent, MD | Hospital Clinic. Barcelona. Spain |
Publications:
Responsible Party: | Hospital General Universitario Gregorio Marañon |
ClinicalTrials.gov Identifier: | NCT00383799 History of Changes |
Other Study ID Numbers: |
2005-001505-25 |
First Posted: | October 4, 2006 Key Record Dates |
Last Update Posted: | April 6, 2016 |
Last Verified: | March 2016 |
Keywords provided by Hospital General Universitario Gregorio Marañon:
Ventricular tachycardia |
Additional relevant MeSH terms:
Tachycardia Tachycardia, Ventricular Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Amiodarone Procainamide Anti-Arrhythmia Agents Vasodilator Agents Potassium Channel Blockers |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Sodium Channel Blockers Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 CYP3A Inhibitors Voltage-Gated Sodium Channel Blockers |