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| Sponsor: | Spanish Society of Cardiology |
|---|---|
| Collaborators: |
Fondo de Investigacion Sanitaria Sanofi-Synthelabo Cordis Corporation Medtronic Guidant Corporation Boston Scientific Corporation |
| Information provided by: | Spanish Society of Cardiology |
| ClinicalTrials.gov Identifier: | NCT00257309 |
Purpose
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 |
|---|---|---|
|
Acute Myocardial Infarction |
Drug: Tenecteplase + UFH (+ clopidogrel, since 01/97) Procedure: Primary angioplasty |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
|
Active Comparator: TT
Weight adjusted TNK + UFH
|
Drug: Tenecteplase + UFH (+ clopidogrel, since 01/97) |
|
Active Comparator: PA
Primary angioplasty
|
Procedure: Primary angioplasty |
Show Detailed Description
Eligibility| 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:
Contacts and Locations| Spain | |
| Hospital Universitario Central de Asturias | |
| Oviedo, Asturias, Spain, 33006 | |
| Hospital Universitario Son Dureta | |
| Palma de Mallorca, Baleares, Spain, 07003 | |
| Hospital Universitario de Bellvitge | |
| Hospitalet de Llobregat, Barcelona, Spain, 08907 | |
| Complejo Hospitalario Universitario de Santiago | |
| Santiago de Compostela, La Coruña, Spain, 15706 | |
| Complejo Hospitalario de León | |
| Leon, León, Spain, 24010 | |
| Hospital Universitario "Virgen de la Victoria" | |
| Malaga, Málaga, Spain, 29010 | |
| Hospital de Navarra | |
| Pamplona, Navarra, Spain, 31008 | |
| Hospital Universitario de Canarias | |
| La Laguna, Tenerife, Spain, 38320 | |
| Hospital de Cruces | |
| Barakaldo, Vizcaya, Spain, 48903 | |
| Hospital de la Santa Creu i Sant Pau | |
| Barcelona, Spain, 08025 | |
| Hospital Clinic i Provincial de Barcelona | |
| Barcelona, Spain, 08036 | |
| 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 12 de Octubre | |
| Madrid, Spain, 28041 | |
| Hospital General Universitario "Gregorio Maranon" | |
| Madrid, Spain, 28007 | |
| Hospital Universitario La Paz | |
| Madrid, Spain, 28046 | |
| Hospital Clínico "San Carlos" | |
| Madrid, Spain, 28040 | |
| Hospital Universitario Marques de Valdecilla | |
| Santander, Spain, 39008 | |
| Hospital Universitario Virgen Macarena | |
| Sevilla, Spain, 41009 | |
| 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 | |
| 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) |
More Information
| Responsible Party: | Spanish Society of Cardiology |
| ClinicalTrials.gov Identifier: | NCT00257309 History of Changes |
| Other Study ID Numbers: | EUDRACT 2004-001943-31, FIS PI042122 |
| Study First Received: | November 18, 2005 |
| Last Updated: | May 19, 2008 |
| Health Authority: | Spain: Spanish Agency of Medicines |
|
Acute myocardial infarction Elderly Thrombolysis Primary angioplasty |
Randomized trial Efficacy Safety |
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Clopidogrel Tenecteplase Platelet Aggregation Inhibitors Hematologic Agents |
Therapeutic Uses Pharmacologic Actions Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Fibrinolytic Agents Fibrin Modulating Agents Cardiovascular Agents |