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Sponsors and Collaborators: |
Spanish Society of Cardiology Fondo de Investigacion Sanitaria Sanofi-Synthelabo Cordis Corporation Medtronic Guidant Corporation Boston Scientific Corporation |
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Information provided by: | Spanish Society of Cardiology |
ClinicalTrials.gov Identifier: | NCT00257309 |
General objective: To compare the efficacy and safety of primary angioplasty(PA) with that of thrombolytic therapy (TT) for the treatment of AMI in patients >=75 years old with ST-segment elevation or LBBB AMI <6 hours of evolution without contraindications for TT.
Hypothesis: The therapeutical strategy based on PA is superior to that based initially on TT in patients >=75 years old with AMI.
Participating Centers: 27 Spanish hospitals performing >50 PA/year. Primary Endpoint (PE): Incidence of the aggregate of death of any cause, reinfarction or disabling stroke at 30 days. There are also 7 secondary endpoints (SE). Procedure: Diagnosis of inclusion/exclusion criteria --> Centralized randomization --> Treatment allocation to 1) TT with weight adjusted TNK + unfractionated heparin or 2) PA within 120 minutes. Estimated Sample size and recruitment time: 570 patients in 19 months. Follow-up: Blinded evaluation of events (PROBE regulations) specified in PE and SE at 30 days and 12 months. Quality control: 100% variable and follow-up review by external CRO.
Safety Committee and Event Adjudication Committee formed by experts not participating in the study.
Condition | Intervention | Phase |
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Acute Myocardial Infarction |
Drug: Tenecteplase + UFH (+ clopidogrel, since 01/97) Procedure: Primary angioplasty |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | TRIANA: A Randomized Trial to Compare the Efficay and Safety of Thrombolysis With Primary Angioplasty as Initial Reperfusion Therapy in Older Patients (>= 75 Years Old) With Acute Myocardial Infarction |
Enrollment: | 266 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | December 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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TT: Active Comparator
Weight adjusted TNK + UFH
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Drug: Tenecteplase + UFH (+ clopidogrel, since 01/97) |
PA: Active Comparator
Primary angioplasty
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Procedure: Primary angioplasty |
Ages Eligible for Study: | 75 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Diagnosis of AMI: chest pain or any symptom of myocardial ischemia of, at least, 20 minutes of duration, not responding to nitrate therapy, an evolution period of less than 6 hours after symptom onset until randomization process, and, at least, one of the following alterations:
EXCLUSION CRITERIA:
Spain | |
Hospital Clinic i Provincial de Barcelona | |
Barcelona, Spain, 08036 | |
Hospital de la Santa Creu i Sant Pau | |
Barcelona, Spain, 08025 | |
Hospital Universitario Virgen de las Nieves | |
Granada, Spain, 18012 | |
Hospital Juan Ramón Jiménez | |
Huelva, Spain, 21005 | |
Complejo Hospitalario Universitario "Juan Canalejo" | |
La Coruña, Spain, 15006 | |
Hospital Universitario Virgen Macarena | |
Sevilla, Spain, 41009 | |
Hospital Clínico "San Carlos" | |
Madrid, Spain, 28040 | |
Hospital 12 de Octubre | |
Madrid, Spain, 28041 | |
Hospital Universitario La Paz | |
Madrid, Spain, 28046 | |
Hospital Universitario Marques de Valdecilla | |
Santander, Spain, 39008 | |
Hospital General Universitario "Gregorio Maranon" | |
Madrid, Spain, 28007 | |
Complejo Hospitalario de Toledo Hospital Virgen de la Salud | |
Toledo, Spain, 45004 | |
Consorcio Hospital General Universitario de Valencia | |
Valencia, Spain, 46014 | |
Hospital Clínico Universitario de Valladolid | |
Valladolid, Spain, 47005 | |
Spain, Asturias | |
Hospital Universitario Central de Asturias | |
Oviedo, Asturias, Spain, 33006 | |
Spain, Baleares | |
Hospital Universitario Son Dureta | |
Palma de Mallorca, Baleares, Spain, 07003 | |
Spain, Barcelona | |
Hospital Universitario de Bellvitge | |
Hospitalet de Llobregat, Barcelona, Spain, 08907 | |
Spain, La Coruña | |
Complejo Hospitalario Universitario de Santiago | |
Santiago de Compostela, La Coruña, Spain, 15706 | |
Spain, León | |
Complejo Hospitalario de León | |
Leon, León, Spain, 24010 | |
Spain, Málaga | |
Hospital Universitario "Virgen de la Victoria" | |
Malaga, Málaga, Spain, 29010 | |
Spain, Navarra | |
Hospital de Navarra | |
Pamplona, Navarra, Spain, 31008 | |
Spain, Tenerife | |
Hospital Universitario de Canarias | |
La Laguna, Tenerife, Spain, 38320 | |
Spain, Vizcaya | |
Hospital de Cruces | |
Barakaldo, Vizcaya, Spain, 48903 |
Principal Investigator: | Hector Bueno, MD, PhD | Spanish Society of Cardiology (WG on Ischemic Heart Disease and CCUs) |
Principal Investigator: | Rosa Ana Hernández-Antolín, MD | Spanish Society of Cardiology (WG on Interventional Cardiology) |
Responsible Party: | Spanish Society of Cardiology |
Study ID Numbers: | EUDRACT 2004-001943-31, FIS PI042122 |
Study First Received: | November 18, 2005 |
Last Updated: | May 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00257309 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
Acute myocardial infarction Elderly Thrombolysis Primary angioplasty |
Randomized trial Efficacy Safety |
Fibrin Modulating Agents Necrosis Heart Diseases Clopidogrel Myocardial Ischemia Vascular Diseases |
Tenecteplase Fibrinolytic Agents Cardiovascular Agents Ischemia Infarction Myocardial Infarction |
Heart Diseases Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Hematologic Agents Vascular Diseases Tenecteplase Fibrinolytic Agents Cardiovascular Agents Ischemia |
Pharmacologic Actions Necrosis Fibrin Modulating Agents Pathologic Processes Therapeutic Uses Cardiovascular Diseases Infarction Myocardial Infarction |